P1299SODIUM ZIRCONIUM CYCLOSILICATE FOR THE TREATMENT OF PERSISTENT HYPERKALAEMIA IN PREVALENT HAEMODIALYSIS PATIENTS: EXPERIENCE FROM CLINICAL PRACTICE

Abstract Background and Aims Sodium zirconium cyclosilicate (SZC) (Lokelma®) is a new oral potassium binder. In September 2019 the UK National Institute for Health and Care Excellence (NICE) did not recommend SZC for dialysis patients due to a lack of evidence. The recent DIALIZE phase 3b randomised controlled trial concluded that SZC is an effective and well-tolerated treatment for hyperkalemia in haemodialysis (HD) patients. We offer an insight into SZC treatment in HD patients with persistent hyperkalaemia in clinical practice. Method Adult prevalent HD patients prescribed SZC for persistent hyperkalaemia were included for analysis. The highest pre-dialysis serum potassium (sK+) values were recorded each month before (M-6 to M-1) and after (M1 to M5) SZC initiation. The primary efficacy measure was a reduction in sK+ with SZC treatment. Results Sixteen patients (mean age 53.5 years, 56.3% male) were included for analysis. 43.8% (n=7) were diabetic. At the time of SZC initiation 43.8% (n=7) received HD via arteriovenous fistula, 12.4% (n=2) via arteriovenous graft and 43.8% (n=7) via tunnelled central venous catheter. The mean Urea Reduction Ratio [SD] was 68.5% [10.8] and the mean [SD] pre-HD bicarbonate was 22.8mmol/L [2.7]. The dialysate potassium prescription was 2mmol/L for 93.8% of patients (n=15) and 1mmol/L for 6.2% of patients (n=1). The mean [SD] achievement of prescribed dialysis hours over the previous 4 weeks was 93.5% [12.2]. 68.8% (n=11) had previous treatment with calcium polystyrene sulfonate and 12.5% (n=2) with patiromer. 18.8% (n=3) were currently prescribed a renin-angiotensin-aldosterone system inhibitor. 93.8% (n=15) had received dietetic advice. SZC starting doses ranged from 5g four times a week on non-dialysis days to 10g three times a day. Mean [SD] sK+ at month-1 (M-1) (immediate pre-treatment period) was 7.38mmol/L [0.31]. Mean [SD] sK+ at month 1 (M1) was 6.37mmol/L [1.21]. The statistical difference between these groups was p=0.0023 (paired two-tailed T-test). Figure 1 includes mean maximum monthly pre-dialysis sK+ from M-6 to M5. SZC was stopped in two patients (after M1 with sK+ 5.0mmol/L and after M4 with sK+ 4.3mmol/L) as it was no longer clinically indicated. Two patients became non-compliant (clinician-suspected or confirmed by patient) with SZC after M2 (sK+ 6.7mmol/L and sK+ 6.4mmol/L). Subsequent sK+ values would not reflect treatment with SZC in these patients. Figure 2 includes mean maximum monthly sK+ for the 12 patients on SZC from M-3 to M5. ANOVA and post-hoc Dunnett’s tests were undertaken to compare SZC treatment months (M1, 2, 3, 4 and 5) to the immediate pre-treatment period (M-1). ANOVA was close to significance (p=0.058), with post-hoc corrected for multiple comparisons finding the data to be significant for M1 vs. M-1 (p=0.045) and M5 vs. M-1 (p=0.018). The same tests across M1 through M5 revealed no significant difference (p=0.968 ANOVA and p=0.555 Dunnett’s), demonstrating that continued treatment with SZC to M5 did not result in a further decline in sK+. Conclusion Sodium zirconium cyclosilicate is effective in reducing pre-dialysis sK+ in patients with moderate and severe hyperkalaemia undergoing haemodialysis in clinical practice.

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Effect of Sutimlimab Treatment on Healthcare Resource Utilization in Patients with Cold Agglutinin Disease

Blood ◽

10.1182/blood-2020-139738 ◽

2020 ◽

Vol 136 (Supplement 1) ◽

pp. 17-18

Author(s):

Alexander Röth ◽

Sophie Guillonneau ◽

Nadege Narcisse ◽

Paulo Carita ◽

Jun Su ◽

...

Keyword(s):

Blood Transfusion ◽

Treatment Period ◽

Healthcare Resource ◽

Post Treatment ◽

Blood Transfusions ◽

Publicly Traded ◽

Post Hoc Analysis ◽

The Mean ◽

Pre Treatment ◽

Post Hoc

Introduction Cold agglutinin disease (CAD) is a serious and rare autoimmune disorder associated with severe fatigue, weakness and other symptoms of chronic anemia and hemolysis. Prior studies have demonstrated that CAD is associated with substantial economic burden and healthcare resource use, including blood transfusions, and highlight an unmet need for novel treatments (Mullins M et al. Blood Adv 2017; Su J et al. J Med Econ 2019). In the pivotal CARDINAL study (Part A), sutimlimab (BIVV009), a monoclonal antibody that targets the underlying cause of hemolysis in CAD by selectively inhibiting complement C1s, provided clinically meaningful improvements with an acceptable safety profile in CAD patients (Röth A et al. Blood 2019). A post hoc analysis was conducted to describe the impact of sutimlimab treatment on healthcare resource utilization (HCRU) in CAD patients. Methods CARDINAL is a Phase 3 open-label, international, multicenter, single-arm study (NCT03347396), evaluating the efficacy, safety, and tolerability of sutimlimab in patients with primary CAD and a recent history of blood transfusion (defined as having ≥1 transfusion 6 months prior to enrollment). The study enrolled 24 patients who received an IV infusion of sutimlimab over approximately 60 minutes on Day 0, Day 7, and every 14 days thereafter through Week 25. Post-hoc analysis of the full analysis set assessed hospitalizations and transfusions that occurred in the 6 month period pre- and post-administration of the first treatment dose. Distribution and descriptive statistics (mean, SD, median, min and max) were determined pre- and post-treatment periods and calculated for the differences between the pre- and post-treatment periods. Results The number of hospitalizations experienced by CAD patients in this post hoc analysis decreased 3.3-fold following sutimlimab treatment: from 10 patients (41.7%) in the pre-treatment period to 3 patients (12.5%) in the post-treatment period. Pre-treatment hospitalizations were the result of CAD-related symptoms or blood transfusion. Reasons for post-treatment hospitalizations included sepsis, infection and blood transfusion. The mean number of hospitalizations per patient decreased post-treatment compared with pre-treatment, but the mean duration of hospitalization per patient was similar between treatment periods (Table). During the post-treatment period, one patient was hospitalized for 18 days due to an infected hematoma following surgery, unrelated to sutimlimab treatment. Nine patients (37.5%) experienced fewer hospitalizations, shortened mean and total hospitalization duration following treatment. Similarly, blood transfusion use by CAD patients also decreased following sutimlimab treatment. Pre-treatment, all patients received ≥1 transfusion, decreasing to 41.7% patients post-treatment. This represented a total of 105 transfusions pre-treatment and 25 transfusions post-treatment, respectively (Table). Overall, 95.9% (23/24) patients received, at least, one less transfusion during the post-treatment versus pre-treatment period. The mean number of units transfused per transfusion was similar pre- and post-treatment; notably, the total number of units transfused decreased from 196 pre-treatment to 43 post-treatment (Table). Conclusion This post hoc analysis of HCRU data from the CARDINAL study provides evidence that CAD is a serious condition that can require hospitalization and blood transfusions. Sutimlimab treatment demonstrates substantial reductions in hospitalizations and blood transfusions. This results in a reduced HCRU impact and decreases the associated burden for hospitals, patients and payers. Disclosures Röth: Roche: Consultancy, Honoraria, Research Funding; Biocryst: Consultancy, Honoraria; Novartis: Consultancy, Honoraria; Sanofi: Consultancy, Honoraria; Apellis: Consultancy, Honoraria; Alexion Pharmaceuticals Inc.: Consultancy, Honoraria, Research Funding. Guillonneau:Sanofi: Current Employment, Current equity holder in publicly-traded company. Narcisse:Sanofi: Consultancy. Carita:Sanofi: Current Employment, Current equity holder in publicly-traded company. Su:Sanofi: Current Employment, Current equity holder in publicly-traded company. Joly:Sanofi: Current Employment, Current equity holder in publicly-traded company.

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Telmisartan in Migraine Prophylaxis: A Randomized, Placebo-Controlled Trial

Cephalalgia ◽

10.1111/j.1468-2982.2008.01825.x ◽

2009 ◽

Vol 29 (9) ◽

pp. 921-927 ◽

Cited By ~ 39

Author(s):

HC Diener ◽

A Gendolla ◽

A Fruersenger ◽

S Evers ◽

A Straube ◽

...

Keyword(s):

Adverse Events ◽

Treatment Period ◽

Controlled Trial ◽

Baseline Period ◽

Migraine Prophylaxis ◽

Symptom Reduction ◽

Double Blind ◽

End Point ◽

Significant Difference ◽

Post Hoc

We evaluated telmisartan 80 mg for migraine prophylaxis. Migraine patients ( n = 95) with three to seven migraine attacks in 3 months were randomized, double-blind to telmisartan or placebo. The primary end-point was the reduction in the number of migraine days (i.e. a day with ≥ 1 h of symptoms) between the 4-week baseline period and the last 4 weeks of the 12-week treatment period. A responder was recorded when there was a symptom reduction of ≥ 50% in these 4-week baseline and treatment periods. The reduction in migraine days was 1.65 with telmisartan and 1.14 with placebo ( P > 0.05). Post hoc analyses adjusting for baseline and centre showed a 38% reduction in migraine days with telmisartan vs. 15% with placebo ( P = 0.03), and a borderline significant difference in responders (40% vs. 25%, P = 0.07). The incidence of adverse events was similar between treatments. This study indicates that telmisartan might be effective in migraine prophylaxis.

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Effect of Delayed Cord Clamping Reduced Anemic Outcome in Preterm Neonate

Journal of the Medical Association of Thailand ◽

10.35755/jmedassocthai.2021.05.9614 ◽

2021 ◽

Vol 104 (5) ◽

pp. 695-700

Keyword(s):

Intraventricular Hemorrhage ◽

Preterm Neonate ◽

Controlled Trial ◽

Preterm Neonates ◽

Maternal Outcomes ◽

Delayed Cord Clamping ◽

Randomized Controlled ◽

Cord Clamping ◽

Significant Difference ◽

The Mean

Objective: To compare the effects of immediate versus delayed cord clamping on neonatal outcomes in preterm neonates of gestational age of 32 to 36⁺⁶ weeks, and maternal outcomes. Materials and Methods: A randomized controlled trial was conducted in the Obstetrics and Gynecology Department at Bhumibol Adulyadej Hospital, in Bangkok, Thailand. The study compared the effects of immediate to delayed cord clamping at 60 seconds among preterm neonates born between 32 weeks, 0 day and 36 weeks, 6 days of gestation between August and October 2018. Results: The mean age of the participants was 26 years old, and half of the cases were nulliparous. One hundred ten women were randomly separated into two equal groups (n=55). Delayed cord clamping at 60 seconds increased hematocrit levels (Hct) in both two (p=0.004) and 48 (p<0.001) hours after delivery compared to the immediate cord clamping group. There were no differences in exposing the neonate to hypothermia, hypoxemia, Apgar score at 1-minute, polycythemia, intraventricular hemorrhage, hyperbilirubinemia, length of stay in hospital, and affecting the process of resuscitation. There were no statistical differences between the two groups in maternal outcomes such as retained placenta and postpartum hemorrhage. Conclusion: Delayed cord clamping at 60 seconds increased Hct in the newborn at two to 48 hours after birth. There was no significant difference in adverse maternal and neonatal complications within both groups. Keywords: Delayed cord clamping, Hematocrit, Preterm

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TOP-PRO study: A randomized double-blind controlled trial of topiramate versus propranolol for prevention of chronic migraine

Cephalalgia ◽

10.1177/03331024211047454 ◽

2021 ◽

pp. 033310242110474

Author(s):

Debashish Chowdhury ◽

Luv Bansal ◽

Ashish Duggal ◽

Debabrata Datta ◽

Ankit Mundra ◽

...

Keyword(s):

Adverse Events ◽

Chronic Migraine ◽

Virus Disease ◽

Controlled Trial ◽

Preventive Treatment ◽

Point Estimate ◽

Tolerability Profile ◽

Double Blind ◽

Significant Difference ◽

The Mean

Objective The aim of the TOP-PRO-study, a double-blind randomized controlled trial, was to assess the efficacy (non-inferiority) and tolerability of propranolol compared to topiramate for the prevention of chronic migraine. Background Except for topiramate, oral preventive treatment for chronic migraine lacks credible evidence. Methods Chronic migraine patients aged above 18 years and less than 65 years of age, not on any preventive treatment were randomly allocated to receive topiramate (100 mg/day) or propranolol (160 mg/day). The primary efficacy outcome was the mean change in migraine days per 28 days at the end of 24 weeks from baseline. A mean difference of 1.5 days per four weeks was chosen as the cut-off delta value. Multiple secondary efficacy outcomes and treatment emergent adverse events were also assessed. Results As against the planned sample size of 244, only 175 patients could be enrolled before the spread of the corona virus disease-2019 pandemic and enforcement of lockdown in India. Of the 175 randomized patients, 95 (topiramate 46 and propranolol 49) completed the trial. The mean change in migraine days was −5.3 ± 1.2 vs −7.3 ± 1.1 days (p = 0.226) for topiramate and propranolol groups respectively. Propranolol was found to be non-inferior and not superior to topiramate (point estimate of −1.99 with a 95% confidence interval of −5.23 to 1.25 days). Multiple secondary outcomes also did not differ between the two groups. Intention to treat analysis of 175 patients and per-protocol analysis of 95 patients yielded concordant results. There was no significant difference in the incidence of adverse events between the two groups. Conclusion Propranolol (160mg/day) was non-inferior, non-superior to topiramate (100mg/day) for the preventive treatment of chronic migraine and had a comparable tolerability profile. Trial Registration: Clinical Trials Registry-India CTRI/2019/05/018997)

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A randomized controlled trial comparing oxytocin administration before and after placental delivery in the prevention of postpartum haemorrhage in a tertiary care hospital in Bankura district of West Bengal, India

International Journal of Reproduction Contraception Obstetrics and Gynecology ◽

10.18203/2320-1770.ijrcog20201791 ◽

2020 ◽

Vol 9 (5) ◽

pp. 1976

Author(s):

Rahul Kirtania ◽

Jayita Pal ◽

Sisir Biswas ◽

Aditi Aich

Keyword(s):

Randomized Controlled Trial ◽

Blood Loss ◽

Controlled Trial ◽

Active Management ◽

Control Group ◽

Care Hospital ◽

Normal Delivery ◽

Randomized Controlled ◽

Significant Difference ◽

The Mean

Background: PPH is the prime cause of maternal mortality worldwide. The incidence of PPH can be drastically combatted by application of uterotonic in active management of third stage labour. Timing of its administration is a matter of concern. This study aimed to assess whether timing of administration of oxytocin would have any impact on incidence or mean blood loss of PPH.Methods: It was a single blinded randomized controlled trial conducted in the department of Obstetrics and Gynecology, Bankura Sammilani Medical College for 6 months where 100 antenatal mothers admitted for normal delivery in labour room were allocated randomly in study and control group considering inclusion and exclusion criteria. Incidence of PPH and mean blood loss had been identified clinically by following them for 24 hours.Results: Only 9% of study population had experienced PPH. There was no statistically significant difference in incidence of PPH with difference in timing of administration of oxytocin (p >0.05). But there was statistically significant decrease in mean blood loss if oxytocin was administered before the placental delivery. The mean blood loss with oxytocin administered before placental delivery was 296.8 ml (102.45) and after placental delivery was 452.0 (128.87) ml respectively.Conclusions: Policy makers should keep in mind not only the incidence of PPH, but the mean blood loss amount too in a setting where anaemia in pregnancy is quite prevalent.

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To Compare the Recurrence Rate of Strictures after Internal Optical Urethrotomy with Intralesional Injection of Mitomycin C versus without Mitomycin C Injection in Patients Presenting with Anterior Urethral Stricture

10.53350/pjmhs2115102856 ◽

2021 ◽

Vol 15 (10) ◽

pp. 2856-2858

Author(s):

Ismat Ullah ◽

Muhammad Waqar Shahid ◽

Muhammad Azeem Mughal ◽

Rahat Usman

Keyword(s):

Mitomycin C ◽

Recurrence Rate ◽

Urethral Stricture ◽

Controlled Trial ◽

P Value ◽

Intralesional Injection ◽

Corpus Spongiosum ◽

Indwelling Catheter ◽

Significant Difference ◽

The Mean

Background: The urethral strictures occurred due to narrowing of urethra. These may occur after an injury or ureteral or excretory system diseases, due to the injury to urothelium or corpus spongiosum that lead to the development of scar tissues. Mitomycin C can be used as chemotherapeutic agent because of its quality of being anti-tumour actions. Aim: To compare the recurrence rate of strictures after internal optical urethrotomy with intralesional injection of Mitomycin C versus without Mitomycin C injection in patients presenting with anterior urethral stricture. Study Design: Randomized controlled trial. Place and Duration of Study: Department of Urology, Lahore General Hospital, Lahore from 5th September 2016 to 5th March 2017. Methodology: Sixty male patients age 18-70 years, diagnosed with anterior (penile and bulbar) urethral stricture up to 2.0cm were included. Patients were randomly divided into two groups; Group A patients were treated with internal optical urethrotomy alone and Group B patients treated with internal optical urethrotomy with intralesional injection of Mitomycin C. After the procedure, an 18F or 20F indwelling catheter left for 7 days. After 6 months, surgical site evaluated and if stricture again developed, then recurrence labeled. Results: The mean age was 39.32±11.38 years, mean duration of stricture was 6.85±3.32 months and the mean stricture size was 1.21±0.45 cm. The recurrence occurred in 18 (30%) patients. Significant difference was noted for recurrence in both groups (p-value<0.05). Conclusion: The recurrence rate with anterior urethral stricture is significantly lower in with Mitomycin C as compared to without Mitomycin C. Keywords: Recurrence, Urethral stricture, Mitomycin C

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OCT-Angiography as a reliable prognostic tool in laser-treated proliferative diabetic retinopathy: The RENOCTA Study

European Journal of Ophthalmology ◽

10.1177/1120672120963451 ◽

2020 ◽

pp. 112067212096345

Author(s):

Marco Lupidi ◽

Ramkailash Gujar ◽

Alessio Cerquaglia ◽

Jay Chhablani ◽

Daniela Fruttini ◽

...

Keyword(s):

Diabetic Retinopathy ◽

Proliferative Diabetic Retinopathy ◽

Additional Treatment ◽

Post Treatment ◽

Vascular Perfusion ◽

Significant Difference ◽

Before And After ◽

The Mean ◽

Pre Treatment ◽

Induced Changes

Purpose: To quantitatively assess retinal neovascularizations (RNVs) in proliferative diabetic retinopathy (PDR) before and after photocoagulative laser treatment (PLT) using Optical Coherence Tomography Angiography (OCT-A). Methods: Consecutive patients with PDR were examined with fluorescein angiography (FA) and OCT-A before and after PLT. Baseline and after-treatment FA images were quantitatively analyzed to assess both the RNVs area and leakage area. On OCT-A RNVs area, vascular perfusion density (VPD), vessel length density (VLD) and fractal dimension were computed. VPD of the full-retina OCT-A underneath the RNV was determined to evaluate potential laser-induced changes in vascular perfusion. Results: Fifteen eyes of 13 patients with PDR were enrolled. The mean area of the RNVs was 0.47 ± 0.50 mm2 in the baseline OCT-A and 0.32 ± 0.40 mm2 in the post-treatment assessment ( p = 0.0002). The mean RNV VPD of RNV was 2% ± 4% in pre-treatment and 1% ± 1% for the post-treatment ( p = 0.0001). The mean VLD of RNV was 7.26 ± 1.53 at baseline and 6.64 ± 1.65 in the post treatment ( p = 0.0002). A significant difference in terms of mean RNVs area and VPD reduction between eyes that needed additional treatment and those that did not (~40% vs ~20%; p < 0.05), was observed. Mean VPD of full-retinal thickness OCT-angiogram was 55% ± 10% for the pre-treatment and 53% ± 8% for the post treatment scan ( p = 0.02). Conclusion: The quantitative OCT-A assessment of laser-induced changes of RNVs can be a useful non-invasive approach for determining treatment efficacy. A reduction of RNVs area or VPD ⩾ 40% might reveal those eyes that won’t require additional treatment. Retinal perfusion impairment seemed to progress independently from the treatment.

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Urinary Steroids in Depressive Illness

Scottish Medical Journal ◽

10.1177/003693307101600403 ◽

1971 ◽

Vol 16 (4) ◽

pp. 224-227 ◽

Cited By ~ 3

Author(s):

A. Balfour Sclare ◽

J. K. Grant

Keyword(s):

Depressive Illness ◽

Post Treatment ◽

Normal Range ◽

Mean Values ◽

Female Patients ◽

Significant Difference ◽

The Mean ◽

Pre Treatment ◽

Depressive Patients ◽

Source Of Information

A longitudinal study of urinary 17-OHCS in 16 depressive patients showed mean values within the accepted normal range. There were no significant differences between pre-treatment and post-treatment values; only the female patients showed a tendency to have somewhat lower post-treatment levels. 17-KS output was measured in 18 depressive patients. The mean values were within the normal range. There was no significant difference between pre-treatment and post-treatment values although the female patients displayed a tendency towards somewhat lower levels following treatment. DHA and EA excretion were measured in 9 depressive patients. There was a very wide variance in the findings. There was no significant difference between pre-treatment and post-treatment levels. The significance of the above findings is discussed. It is considered that measurements of urinary excretion of corticosteroids in affective disorders constitute a limited source of information.

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Contamination and washing of cloth masks and risk of infection among hospital health workers in Vietnam: a post hoc analysis of a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-042045 ◽

2020 ◽

Vol 10 (9) ◽

pp. e042045

Author(s):

Chandini Raina MacIntyre ◽

Tham Chi Dung ◽

Abrar Ahmad Chughtai ◽

Holly Seale ◽

Bayzidur Rahman

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Poor Performance ◽

Full Time ◽

Risk Of Infection ◽

Viral Contamination ◽

Post Hoc Analysis ◽

Significant Difference ◽

Randomised Controlled ◽

Post Hoc

BackgroundIn a previous randomised controlled trial (RCT) in hospital healthcare workers (HCWs), cloth masks resulted in a higher risk of respiratory infections compared with medical masks. This was the only published RCT of cloth masks at the time of the COVID-19 pandemic.ObjectiveTo do a post hoc analysis of unpublished data on mask washing and mask contamination from the original RCT to further understand poor performance of the two-layered cotton cloth mask used by HCWs in that RCT.Setting14 secondary-level/tertiary-level hospitals in Hanoi, Vietnam.ParticipantsA subgroup of 607 HCWs aged ≥18 years working full time in selected high-risk wards, who used a two-layered cloth mask and were part of a randomised controlled clinical trial comparing medical masks and cloth masks.InterventionWashing method for cloth masks (self-washing or hospital laundry). A substudy of contamination of a sample of 15 cloth and medical masks was also conducted.Outcome measureInfection rate over 4 weeks of follow up and viral contamination of masks tested by multiplex PCR.ResultsViral contamination with rhinovirus was identified on both used medical and cloth masks. Most HCW (77% of daily washing) self-washed their masks by hand. The risk of infection was more than double among HCW self-washing their masks compared with the hospital laundry (HR 2.04 (95% CI 1.03 to 4.00); p=0.04). There was no significant difference in infection between HCW who wore cloth masks washed in the hospital laundry compared with medical masks (p=0.5).ConclusionsUsing self-reported method of washing, we showed double the risk of infection with seasonal respiratory viruses if masks were self-washed by hand by HCWs. The majority of HCWs in the study reported hand-washing their mask themselves. This could explain the poor performance of two layered cloth masks, if the self-washing was inadequate. Cloth masks washed in the hospital laundry were as protective as medical masks. Both cloth and medical masks were contaminated, but only cloth masks were reused in the study, reiterating the importance of daily washing of reusable cloth masks using proper method. A well-washed cloth mask can be as protective as a medical mask.Trial resgistration numberACTRN12610000887077.

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Prevention of Intraoperative Awareness with Explicit Recall in an Unselected Surgical Population

Anesthesiology ◽

10.1097/aln.0b013e31826904a6 ◽

2012 ◽

Vol 117 (4) ◽

pp. 717-725 ◽

Cited By ~ 164

Author(s):

George A. Mashour ◽

Amy Shanks ◽

Kevin K. Tremper ◽

Sachin Kheterpal ◽

Christopher R. Turner ◽

...

Keyword(s):

Medical Center ◽

Controlled Trial ◽

Academic Medical Center ◽

Secondary Analysis ◽

Intraoperative Awareness ◽

Anesthetic Concentration ◽

Significant Difference ◽

Explicit Recall ◽

Monitoring Protocols ◽

Post Hoc

Background Intraoperative awareness with explicit recall occurs in approximately 0.15% of all surgical cases. Efficacy trials based on the Bispectral Index® (BIS) monitor (Covidien, Boulder, CO) and anesthetic concentrations have focused on high-risk patients, but there are no effectiveness data applicable to an unselected surgical population. Methods We conducted a randomized controlled trial of unselected surgical patients at three hospitals of a tertiary academic medical center. Surgical cases were randomized to alerting algorithms based on either BIS values or anesthetic concentrations. The primary outcome was the incidence of definite intraoperative awareness; prespecified secondary outcomes included postanesthetic recovery variables. Results The study was terminated because of futility. At interim analysis the incidence of definite awareness was 0.12% (11/9,376) (95% CI: 0.07-0.21%) in the anesthetic concentration group and 0.08% (8/9,460) (95% CI: 0.04-0.16%) in the BIS group (P = 0.48). There was no significant difference between the two groups in terms of meeting criteria for recovery room discharge or incidence of nausea and vomiting. By post hoc secondary analysis, the BIS protocol was associated with a 4.7-fold reduction in definite or possible awareness events compared with a cohort receiving no intervention (P = 0.001; 95% CI: 1.7-13.1). Conclusion This negative trial could not detect a difference in the incidence of definite awareness or recovery variables between monitoring protocols based on either BIS values or anesthetic concentration. By post hoc analysis, a protocol based on BIS monitoring reduced the incidence of definite or possible intraoperative awareness compared with routine care.

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