No Difference between Spinal Anesthesia with Hyperbaric Ropivacaine and Intravenous Dexmedetomidine Sedation with and without Intrathecal Fentanyl: A Randomized Noninferiority Trial

To enhance the duration of single-shot spinal anesthesia, intrathecal fentanyl and intravenous dexmedetomidine are widely used as adjuvants to local anesthetics. This noninferiority trial evaluated whether hyperbaric ropivacaine alone can produce a noninferior duration of sensory block in comparison to hyperbaric ropivacaine with intrathecal fentanyl in patients under dexmedetomidine sedation. Methods. Fifty patients scheduled for elective lower limb surgery under spinal anesthesia were randomly assigned in a double-blind fashion to receive either hyperbaric ropivacaine 15 mg (Group R) or hyperbaric ropivacaine 15 mg with intrathecal fentanyl 20 μg (Group RF). Intravenous dexmedetomidine (1 μg/kg for 10 min, followed by 0.5 μg/kg/h) was administered in both groups. The primary outcome of this study was the time to two-dermatomal regression of sensory block. The noninferiority margin for the mean difference was −10 min. Characteristics of the block, intraoperative and postoperative side effects, postoperative pain score, and analgesic consumption were assessed as secondary outcomes. Results. There was no difference in the two-dermatomal regressions of sensory block between the two groups (Group R 70.4 ± 10.2 min, Group RF 71.2 ± 12.4 min, p = 0.804) with a mean difference of 0.8 min (−7.2 to 5.6, 95% confidence interval). Thus, the noninferiority of hyperbaric ropivacaine alone was established. There were no significant differences in the secondary outcomes between the two groups. Conclusions. Under intravenous dexmedetomidine sedation, the duration of spinal anesthesia with hyperbaric ropivacaine alone was noninferior to that of hyperbaric ropivacaine with intrathecal fentanyl. This suggests that addition of intrathecal fentanyl to hyperbaric ropivacaine may not be necessary in patients receiving intravenous dexmedetomidine.

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Comparison of bupivacaine plus intrathecal fentanyl and bupivacaine alone for spinal anesthesia with intravenous dexmedetomidine sedation: a randomized, double-blind, noninferiority trial

Regional Anesthesia and Pain Medicine ◽

10.1136/rapm-2018-100084 ◽

2019 ◽

Vol 44 (4) ◽

pp. 459-465 ◽

Cited By ~ 2

Author(s):

Sun-Kyung Park ◽

Joon Hee Lee ◽

Seokha Yoo ◽

Won Ho Kim ◽

Young-Jin Lim ◽

...

Keyword(s):

Spinal Anesthesia ◽

Sensory Block ◽

Mean Difference ◽

Double Blind ◽

Significant Difference ◽

Registration Number ◽

Total Knee ◽

The Mean ◽

Secondary Outcomes ◽

Group B

Background and objectivesFentanyl is widely used as an intrathecal adjuvant to local anesthetics to enhance the duration of spinal anesthesia. Recent evidence suggests that intravenous dexmedetomidine prolongs the duration of spinal anesthesia. This noninferiority study evaluated whether bupivacaine alone could provide a noninferior duration of block compared with bupivacaine and fentanyl when intravenous dexmedetomidine was administered intraoperatively.MethodsFifty-six patients scheduled for total knee arthroplasty under spinal anesthesia were randomly allocated to receive either bupivacaine 13 mg with intrathecal fentanyl 20 µg (Group BF) or bupivacaine 13 mg (Group B). Both groups underwent intravenous dexmedetomidine sedation throughout the surgery (1 µg kg–1 for 10 min, followed by 0.5 µg kg–1 h–1). The primary outcome was the time to two-segment regression of the sensory block. The noninferiority margin for the mean difference was predefined as −10 min. Secondary outcomes included postoperative pain scores, analgesics consumptions, and the incidences of pruritus, nausea, and vomiting.ResultsThere was no significant difference in the two-segment regression time of sensory block (Group B 109.1±25.0 min vs Group BF 104.3±25.9 min; p=0.484). The mean difference in the two-segment regression time between the 2 groups was 4.8 min (95 % CI −8.9 to 18.6), demonstrating the noninferiority of bupivacaine alone. Secondary outcomes showed no significant differences between the two groups.ConclusionsThe duration of spinal anesthesia with bupivacaine alone is noninferior to that of bupivacaine plus fentanyl in patients receiving intravenous dexmedetomidine intraoperatively. Our results suggest that intrathecal fentanyl may not be required when intravenous dexmedetomidine is administered.Trial registration numberNCT03105115.

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Efficacy of tocilizumab in patients with hand osteoarthritis: double blind, randomised, placebo-controlled, multicentre trial

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-218547 ◽

2020 ◽

pp. annrheumdis-2020-218547

Author(s):

Pascal Richette ◽

Augustin Latourte ◽

Jérémie Sellam ◽

Daniel Wendling ◽

Muriel Piperno ◽

...

Keyword(s):

Primary Outcome ◽

Controlled Study ◽

Hand Osteoarthritis ◽

Double Blind ◽

Osteoarthritis Pain ◽

Inflammatory Drugs ◽

The Mean ◽

Secondary Outcomes ◽

And Function ◽

To Receive

ObjectiveTo evaluate the efficacy of tocilizumab, an antibody against IL-6 receptor, in patients with hand osteoarthritis.MethodsThis was a multicentre, 12-week, randomised, double-blind, placebo-controlled study from November 2015 to October 2018. Patients with symptomatic hand osteoarthritis (pain ≥40 on a 0–100 mm visual analogue scale (VAS) despite analgesics and non-steroidal anti-inflammatory drugs; at least three painful joints, Kellgren-Lawrence grade ≥2) were randomised to receive two infusions 4 weeks apart (weeks 0 and 4) of tocilizumab (8 mg/kg intravenous) or placebo. The primary endpoint was changed in VAS pain at week 6. Secondary outcomes included the number of painful and swollen joints, duration of morning stiffness, patients’ and physicians’ global assessment and function scores.ResultsOf 104 patients screened, 91 (45 to tocilizumab and 46 to placebo; 82% women; mean age 64.4 (SD 8.7) years) were randomly assigned and 79 completed the 12-week study visit. The mean change between baseline and week 6 on the VAS for pain (primary outcome) was −7.9 (SD 19.4) and −9.9 (SD 20.1) in the tocilizumab and placebo groups (p=0.7). The groups did not differ for any secondary outcomes at weeks 4, 6, 8 or 12. Overall, adverse events were slightly more frequent in the tocilizumab than placebo group.ConclusionTocilizumab was no more effective than placebo for pain relief in patients with hand osteoarthritis.

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Clinical Comparative Study between Fentanyl and Dexmedetomidine with Bupivacaine for Lower Limb Surgery in Spinal Anaesthesia

Academia Anesthesiologica International ◽

10.21276/aan.2020.5.1.25 ◽

2020 ◽

Vol 5 (1) ◽

pp. 126-130

Author(s):

Tuhin Vashishth ◽

Sangeeta Varun

Keyword(s):

Spinal Anesthesia ◽

Lower Limb ◽

Motor Block ◽

Sensory Block ◽

Double Blind Study ◽

Hyperbaric Bupivacaine ◽

Double Blind ◽

Block Time ◽

Lower Limb Surgery ◽

Group D

Background: Spinal anesthesia is a preferred technique of choice in infraumbilical surgeries. The spinal anesthesia effect can be improved by adding various adjuvant like Fentanyl, clonidine, dexmedetomidine. Dexmedetomidine is a highly selective alpha 2 adrenergic agonists. The aim of study to compare efficacy and safety between Dexmedetomidine and Fentanyl with Bupivacaine.Subjects and Methods:A prospective randomized, double-blind study was conducted on 100 patient by dividing them into two groups. Group D: 2.5ml (12.5mg) of 0.5% hyperbaric bupivacaine with 5mcg (0.5ml) dexmedetomidine and Group F : 2.5ml(12.5mg) of 0.5% hyperbaric bupivacaine with 2 5mcg(0.5ml) fentanyl. The total volume injected intrathecally was 3.0ml in ASA I and II grade patient undergoing lower limb surgery.Results:Patients in dexmedetomidine groupD had a significantly longer sensory and motor block time than patients in fentanyl group F.The mean time of sensory regression to level S1 was 306.00 ± 13 .32 in group D and 206.14± 16.69 in group F(P<0.001). The regression time of motor block to reach modified Bromage 0 was 257.70±14.61 in group D and 178.54±14.23 in group F(P<0.001).Conclusion:Intrathecal Dexmedetomidine is associated with prolonging motor and sensory block as compare to Fentanyl.

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Effects of addition of Magnesium sulphate to heavy Bupivacaine for spinal anesthesia in vaginal hysterectomy

Journal of Kathmandu Medical College ◽

10.3126/jkmc.v2i2.10628 ◽

2014 ◽

Vol 2 (2) ◽

pp. 63-68

Author(s):

Sushila Tabdar ◽

Uzma Shrestha ◽

Ekraj Kadariya

Keyword(s):

Spinal Anesthesia ◽

Spinal Anaesthesia ◽

Magnesium Sulphate ◽

Vaginal Hysterectomy ◽

Motor Block ◽

Sensory Block ◽

P Value ◽

Double Blind ◽

Medical College ◽

To Receive

Background: Adequate pain management is essential for every patient to recover and return to their normal activity quickly. Central sensitization is one of the mechanism which increases excitability of spinal neurons and results persistent pain postoperatively. Objectives: The aim of the study was to investigate the effects of addition of 100 mg 50% Magnesium Sulphate intrathecally to 0.5% heavy Bupivacaine on sensory onset up to T4 level, complete motor block, post-operative analgesia and complications in patients planned for vaginal hysterectomy under spinal anesthesia. Methods: The design of the study was prospective randomized and double blind. With the Institutional improvements and informed consent in Kathmandu Medical College from January 2011 till December 2012, 60 American society of Anesthesiologist class (I, II) patients of age between (40 to 70) years, weight between (45 to 70) kg and height between (4.8 to 5.2) feet undergoing routine vaginal hysterectomy not exceeding one and half hour in spinal anaesthesia were included in the study. The exclusion criteria were patients not following above criteria, having coagulopathy, renal function derangements, uncontrolled hypertension or severe hypotension and having dysarrhythmias. Total patients were randomized into two groups of thirty each. Group A was allocated to receive four ml 0.5% Bupivacaine +0.25 ml normal saline and group B was allocated to receive four ml 0.5% Bupivacaine + 100 mg of 50% Magnesium Sulphate. The anaesthesiologist who was double blind to the drug preparation performed spinal anaesthesia with either of the drug for the whole study.The recorded parameters were time of onset of sensory block upto T4 level, onset of complete motor block, total duration of analgesia and complications in both the groups. Data analysis was done by Computer software polystat XLS using Student’s “t” test. P value <0.05 was considered statistically significant. Result: The addition of 100 mg of 50% Magnesium sulphate to 0.5% Bupivacaine intrathecally resulted early onset of sensory block upto T4 level in (Mean± SD) (3.79 ± 0.25) min Vs (9.61 ± 0.75) min with sole 0.5% Bupivacaine where p value was < 0.05. Similarly onset of complete motor block with 0.5% Bupivacaine plus Magnesium Sulphate was (1.9 ± 0.23) min verses (10.4 ± 0.63) min with 0.5 % Bupivacaine only. Here again p value was < 0.05. Duration of analgesia with 0.5 % Bupivacaine plus Magnesium Sulphate was (176.8 ± 19. 85) min than that of 0.5% Bupivacaine (105 ± 26.82) min with P value< 0.05. Conclusion: The study concluded that onset as well as analgesic effect of 0.5% Bupivacaine was potentiated by intrathecal Magnesium Sulphate without major side effects.DOI: http://dx.doi.org/10.3126/jkmc.v2i2.10628Journal of Kathmandu Medical College, Vol. 2, No. 2, Issue 4, Apr.-Jun., 2013, Page: 63-68

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The Antiaggressive Action of Combined Haloperidol-Propranolol Treatment in Schizophrenia

European Psychologist ◽

10.1027//1016-9040.5.4.312 ◽

2000 ◽

Vol 5 (4) ◽

pp. 312-325 ◽

Cited By ~ 9

Author(s):

Gadi Maoz ◽

Daniel Stein ◽

Sorin Meged ◽

Larisa Kurzman ◽

Joseph Levine ◽

...

Keyword(s):

Rating Scales ◽

Double Blind ◽

Propranolol Group ◽

Schizophrenic Patients ◽

Propranolol Treatment ◽

Simultaneous Decrease ◽

The Mean ◽

Haloperidol Treatment ◽

To Receive ◽

Drug Free

Psychopharmacological interventions for managing aggression in schizophrenia have thus far yielded inconsistent results. This study evaluates the antiaggressive efficacy of combined haloperidol-propranolol treatment. Thirty-four newly admitted schizophrenic patients were studied in a controlled double-blind trial. Following a 3-day drug-free period and 7 days of haloperidol treatment, patients were randomly assigned to receive either haloperidol-propranolol or haloperidol-placebo for eight consecutive weeks. Doses of medications were adjusted as necessary; biperiden was administered if required. Rating scales were applied to assess aggression, anger, psychosis, depression, anxiety and extrapyramidal symptoms. The mean daily dose of haloperidol was 21 mg (SD = 6.4) in the research group and 29 mg (SD = 6.9) in the controls. Mean and maximal daily doses of propranolol were 159 mg (SD = 61) and 192 mg (SD = 83), and of placebo, 145 mg (SD = 50) and 180 mg (SD = 70), respectively. Compared with the controls, the scores for the research patients decreased significantly from baseline, particularly after 4 weeks of treatment, for some dimensions of anger, psychosis, anxiety, and neuroleptic-induced parkinsonism. A tendency for reduced aggression was shown in the combined haloperidol-propranolol group for some dimensions but not others. These patients also required significantly less biperiden. The tendency toward elevated antiaggressive effect of combined haloperidol-propranolol treatment compared to haloperidol alone may be explained by a simultaneous decrease in aggression, psychotic symptomatology, and anxiety.

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Preemptive ganciclovir for mechanically ventilated patients with cytomegalovirus reactivation

Annals of Intensive Care ◽

10.1186/s13613-020-00793-2 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Laurent Papazian ◽

◽

Samir Jaber ◽

Sami Hraiech ◽

Karine Baumstarck ◽

...

Keyword(s):

Mechanical Ventilation ◽

Invasive Mechanical Ventilation ◽

Double Blind ◽

Intravenous Ganciclovir ◽

Subdistribution Hazard ◽

Mechanically Ventilated ◽

Cytomegalovirus Reactivation ◽

Secondary Outcomes ◽

To Receive ◽

Cmv Reactivation

Abstract Background The effect of cytomegalovirus (CMV) reactivation on the length of mechanical ventilation and mortality in immunocompetent ICU patients requiring invasive mechanical ventilation remains controversial. The main objective of this study was to determine whether preemptive intravenous ganciclovir increases the number of ventilator-free days in patients with CMV blood reactivation. Methods This double-blind, placebo-controlled, randomized clinical trial involved 19 ICUs in France. Seventy-six adults ≥ 18 years old who had been mechanically ventilated for at least 96 h, expected to remain on mechanical ventilation for ≥ 48 h, and exhibited reactivation of CMV in blood were enrolled between February 5th, 2014, and January 23rd, 2019. Participants were randomized to receive ganciclovir 5 mg/kg bid for 14 days (n = 39) or a matching placebo (n = 37). Results The primary endpoint was ventilator-free days from randomization to day 60. Prespecified secondary outcomes included day 60 mortality. The trial was stopped for futility based on the results of an interim analysis by the DSMB. The subdistribution hazard ratio for being alive and weaned from mechanical ventilation at day 60 for patients receiving ganciclovir (N = 39) compared with control patients (N = 37) was 1.14 (95% CI from 0.63 to 2.06; P = 0.66). The median [IQR] numbers of ventilator-free days for ganciclovir-treated patients and controls were 10 [0–51] and 0 [0–43] days, respectively (P = 0.46). Mortality at day 60 was 41% in patients in the ganciclovir group and 43% in the placebo group (P = .845). Creatinine levels and blood cells counts did not differ significantly between the two groups. Conclusions In patients mechanically ventilated for ≥ 96 h with CMV reactivation in blood, preemptive ganciclovir did not improve the outcome.

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489 Pivotal Phase 3 Study of FT218, a Once-Nightly Sodium Oxybate Formulation, in Patients With Narcolepsy: REST-ON Primary Results

SLEEP ◽

10.1093/sleep/zsab072.488 ◽

2021 ◽

Vol 44 (Supplement_2) ◽

pp. A193-A193

Author(s):

Clete Kushida ◽

Colin Shapiro ◽

Thomas Roth ◽

Michael Thorpy ◽

Russell Rosenberg ◽

...

Keyword(s):

Adverse Reactions ◽

Sleep Latency ◽

Sodium Oxybate ◽

Mean Difference ◽

Pivotal Phase ◽

Double Blind ◽

Old Patients ◽

Maintenance Of Wakefulness Test ◽

To Receive ◽

Clinical Global Impression Improvement

Abstract Introduction Sodium oxybate (SO) is an effective treatment for patients with narcolepsy; however, currently available SO formulations require twice-nightly dosing. The purpose of this study was to evaluate efficacy and safety of FT218, an investigational once-nightly controlled-release SO formulation, for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy types 1 (NT1) and 2 (NT2). Methods This was a randomized, double-blind, placebo-controlled, multicenter study in patients with narcolepsy ≥16 years old. Patients were randomized 1:1 to receive FT218 or matching placebo: 4.5 g/night for 1 week, 6.0 g/night for 2 weeks, 7.5 g/night for 5 weeks, and 9.0 g/night for 5 weeks (maximum treatment duration, 13 weeks). Coprimary endpoints were mean sleep latency (minutes) on maintenance of wakefulness test (MWT), Clinical Global Impression-Improvement (CGI-I) of sleepiness, and weekly number of cataplexy attacks (NCAs; NT1 only). Results A total of 212 patients were randomized and received study treatment (FT218, n=107; placebo, n=105). FT218 showed significant (P<0.001) improvement vs placebo in mean sleep latency on MWT for all evaluated doses; LS mean difference (minutes) between FT218 and placebo was 6.13 at 9.0 g (week 13), 6.21 at 7.5 g (week 8), and 4.98 at 6.0 g (week 3). A higher proportion of patients receiving FT218 were much/very much improved on CGI-I vs placebo (72% vs 31.6% at 9.0 g; 62.6% vs 22.8% at 7.5 g; and 40.1% vs 6.1% at 6.0 g; all P<0.001). LS mean difference between FT218 and placebo in mean weekly NCAs was significant (P<0.001) for all doses: −6.65 at 9.0 g, −6.27 at 7.5 g, and −4.83 at 6.0 g. The most common adverse reactions were nausea, vomiting, headache, dizziness, enuresis, and decreased appetite. Conclusion All evaluated doses of FT218 showed significant improvement vs placebo in mean sleep latency on MWT, CGI-I, and weekly NCAs. FT218 was generally well tolerated and the most common adverse events were consistent with known side effects of SO. Support (if any) Avadel Pharmaceuticals.

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A Parallel-Group Comparison of Astemizole and Loratadine for the Treatment of Perennial Allergic Rhinitis

Journal of International Medical Research ◽

10.1177/030006059702500401 ◽

1997 ◽

Vol 25 (4) ◽

pp. 175-181 ◽

Cited By ~ 66

Author(s):

H Al-Muhaimeed

Keyword(s):

Allergic Rhinitis ◽

Statistical Significance ◽

Double Blind Study ◽

Perennial Allergic Rhinitis ◽

Double Blind ◽

Once Daily ◽

Runny Nose ◽

Parallel Group ◽

The Mean ◽

To Receive

The efficacy and safety of the two antihistamines, astemizole and loratadine, were compared in a double-blind study of 84 patients with perennial allergic rhinitis. Patients were randomized to receive orally either astemizole 10 mg once daily ( n = 40) or loratadine 10 mg once daily ( n = 44) for 1 week. No other antirhinitis medication was allowed during the study. By day 7 the mean daily symptom scores, recorded on diary cards, were lower in patients receiving astemizole than in those receiving loratadine for runny nose, itchy nose and sneezing, although not for blocked nose, and treatment differences only reached statistical significance for runny nose. After 7 days, 53.75% of patients on astemizole and 38.6% on loratadine were free of symptoms, and 87% of patients on astemizole described the treatment as good or excellent compared with 62% on loratadine. The present results suggest that astemizole may be more effective than loratadine in controlling symptoms of perennial allergic rhinitis.

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A Double-Blind Randomized Prospective Study Comparing Ondansetron with Droperidol in the Prevention of Emesis following Strabismus Surgery

Anaesthesia and Intensive Care ◽

10.1177/0310057x9502300404 ◽

1995 ◽

Vol 23 (4) ◽

pp. 438-443 ◽

Cited By ~ 25

Author(s):

A. Davis ◽

S. Krige ◽

D. Moyes

Keyword(s):

Recovery Time ◽

Strabismus Surgery ◽

Double Blind Study ◽

Double Blind ◽

Oral Fluids ◽

Group A ◽

The Mean ◽

Group B ◽

To Receive ◽

Mean Time

A prospective double-blind study was conducted to compare the anti-emetic efficacy of ondansetron and droperidol in preventing postoperative emesis following strabismus surgery. A sample size of 213 patients was divided into three equal groups to receive ondansetron 150 μg/kg (Group A), ondansetron 75 μg/kg (Group B), or droperidol 75 fig/kg (Group C). All patients received a standardized anaesthetic technique. All episodes of emesis, recovery time, and time to tolerating oral fluids were recorded. The incidence of emesis during 24 hours was Groups A and B 19.7%, and Group C 28.2%. The lower incidence of emesis recorded by the ondansetron groups compared with the droperidol group was not statistically significant. Ondansetron at 75 μg/kg was as effective as 150 μg/kg in reducing emesis when compared with droperidol. Mean time to discharge from the recovery room was 75.3 minutes (Group A), 44.4 minutes (Group B), and 41.0 minutes (Group C). The mean time to tolerating oral fluids was 356.5 minutes (Group A), 402.8 minutes (Group B), and 378.1 minutes (Group C). There was no statistical difference in discharge times from recovery or time to tolerating oral fluids in any of the three groups.

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