Dexmedetomidine Induces Low Patient State Indices While Preventing the Development of Postoperative Delirium in Older Patients Undergoing General Anesthesia - A Secondary Analysis of a Randomized Controlled Trial (NEUPRODEX)

Abstract Background: Dexmedetomidine may have a delirium preventive effect in high-risk surgical patients. Accurate frontal EEG-guided anesthesia can decrease the incidence of postoperative delirium by avoiding too deep anesthesia. Aim of our study is to evaluate the incidence of postoperative delirium under intraoperative frontal EEG neuromonitoring during general anesthesia with dexmedetomidine.Methods: A secondary analysis of a single-center, randomized, double-blinded, placebo-controlled trial. Patients > 60 years were included with either abdominal or cardiac surgery, receiving intraoperative dexmedetomidine or placebo. Delirium incidence was measured up to the fifth postoperative day. Anesthetic depth was measured as Patient State Index (PSi™) every 15 minutes during surgery using EEG-based neuromonitoring.Results: Of the 60 patients included, the incidence of postoperative delirium was significantly reduced in the dexmedetomidine group (n=28) vs. the control group (n=32) (p=0.031). A PSi less than 25 at least once was seen in 85.2% of the verum group and 58.1% of the placebo group (p=0.024). The mean (SD) PSi value in the dexmedetomidine group was 28.17 (10.35) and 33.55 (11.31) in the placebo group using mixed-model ANOVA.Conclusions: Intraoperative Dexmedetomidine reduces the incidence of postoperative delirium in older patients at risk, although presenting with lower intraoperative PSi levels.

Download Full-text

Delirium in Older Patients after Combined Epidural–General Anesthesia or General Anesthesia for Major Surgery: A Randomized Trial

Anesthesiology ◽

10.1097/aln.0000000000003834 ◽

2021 ◽

Author(s):

Ya-Wei Li ◽

Huai-Jin Li ◽

Hui-Juan Li ◽

Bin-Jiang Zhao ◽

Xiang-Yang Guo ◽

...

Keyword(s):

At Risk ◽

Relative Risk ◽

General Anesthesia ◽

Epidural Anesthesia ◽

Older Patients ◽

Postoperative Delirium ◽

Number Needed To Treat ◽

General Anesthesia Group ◽

Anesthesia Group ◽

Patients At Risk

Background Delirium is a common and serious postoperative complication, especially in the elderly. Epidural anesthesia may reduce delirium by improving analgesia, reducing opioid consumption, and blunting stress response to surgery. This trial therefore tested the hypothesis that combined epidural–general anesthesia reduces the incidence of postoperative delirium in elderly patients recovering from major noncardiac surgery. Methods Patients aged 60 to 90 yr scheduled for major noncardiac thoracic or abdominal surgeries expected to last 2 h or more were enrolled. Participants were randomized 1:1 to either combined epidural–general anesthesia with postoperative epidural analgesia or general anesthesia with postoperative intravenous analgesia. The primary outcome was the incidence of delirium, which was assessed with the Confusion Assessment Method for the Intensive Care Unit twice daily during the initial 7 postoperative days. Results Between November 2011 and May 2015, 1,802 patients were randomized to combined epidural–general anesthesia (n = 901) or general anesthesia alone (n = 901). Among these, 1,720 patients (mean age, 70 yr; 35% women) completed the study and were included in the intention-to-treat analysis. Delirium was significantly less common in the combined epidural–general anesthesia group (15 [1.8%] of 857 patients) than in the general anesthesia group (43 [5.0%] of 863 patients; relative risk, 0.351; 95% CI, 0.197 to 0.627; P < 0.001; number needed to treat 31). Intraoperative hypotension (systolic blood pressure less than 80 mmHg) was more common in patients assigned to epidural anesthesia (421 [49%] vs. 288 [33%]; relative risk, 1.47, 95% CI, 1.31 to 1.65; P < 0.001), and more epidural patients were given vasopressors (495 [58%] vs. 387 [45%]; relative risk, 1.29; 95% CI, 1.17 to 1.41; P < 0.001). Conclusions Older patients randomized to combined epidural–general anesthesia for major thoracic and abdominal surgeries had one third as much delirium but 50% more hypotension. Clinicians should consider combining epidural and general anesthesia in patients at risk of postoperative delirium, and avoiding the combination in patients at risk of hypotension. Editor’s Perspective What We Already Know about This Topic What This Article Tells Us That Is New

Download Full-text

Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

Otolaryngology ◽

10.1177/0194599821994742 ◽

2021 ◽

pp. 019459982199474

Author(s):

Maggie Xing ◽

Dorina Kallogjeri ◽

Jay F. Piccirillo

Keyword(s):

Randomized Controlled Trial ◽

Cognitive Training ◽

Mixed Model ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Functional Index ◽

Open Label ◽

Randomized Controlled ◽

The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

Download Full-text

The effect of opioid-free anesthesia on the quality of recovery after gynecological laparoscopy: study protocol for a prospective randomized controlled trial

Trials ◽

10.1186/s13063-021-05166-z ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Jae Yen Song ◽

Hoon Choi ◽

Minsuk Chae ◽

Jemin Ko ◽

Young Eun Moon

Keyword(s):

General Anesthesia ◽

Assessment Tool ◽

Controlled Trial ◽

Perioperative Period ◽

Postoperative Outcomes ◽

Control Group ◽

Quality Of Recovery ◽

Gynecological Laparoscopy ◽

Prospective Randomized Controlled Trial

Abstract Background Because of the indiscriminate use of opioids during the perioperative period, opioid-free anesthesia (OFA) has been increasingly required. Nevertheless, the studies on the detailed techniques and effects of OFA are not sufficient. The Quality of Recovery-40 (QoR-40) questionnaire is a validated assessment tool for measuring recovery from general anesthesia. However, no study has used the QoR-40 to determine if OFA leads to better recovery than standard general anesthesia. Therefore, we aim to perform this study to determine the effects of OFA using dexmedetomidine and lidocaine on the quality of recovery as well as the various postoperative outcomes. Methods The participants (n = 78) will be allocated to one of the two groups; the study group will receive bolus and infusion of dexmedetomidine and lidocaine, and the control group will receive remifentanil infusion during general anesthesia for gynecological laparoscopy. The other processes including anesthetic and postoperative care will be performed similarly in the two groups. Intraoperative hemodynamic, anesthetic, and nociceptive variables will be recorded. Postoperative outcomes such as QoR-40, pain severity, and opioid-related side effects will be assessed. Additionally, an ancillary cytokine study (inflammatory cytokine, stress hormone, and reactive oxygen species) will be performed during the study period. Discussion This will be the first study to determine the effect of OFA, using the combination of dexmedetomidine and lidocaine, on the quality of recovery after gynecological laparoscopy compared with standard general anesthesia using remifentanil. The findings from this study will provide scientific and clinical evidence on the efficacy of OFA. Trial registration ClinicalTrials.gov NCT04409964. Registered on 28 May 2020

Download Full-text

A Randomized Controlled Trial Evaluating Integrative Psychotherapeutic Group Treatment Compared to Self-Help Groups in Functional Vertigo/Dizziness

Journal of Clinical Medicine ◽

10.3390/jcm10102215 ◽

2021 ◽

Vol 10 (10) ◽

pp. 2215

Author(s):

Karina Limburg ◽

Katharina Radziej ◽

Heribert Sattel ◽

Peter Henningsen ◽

Marianne Dieterich ◽

...

Keyword(s):

Group Treatment ◽

Mixed Model ◽

Linear Mixed Model ◽

Controlled Trial ◽

Clinical Psychologist ◽

Control Group ◽

Attrition Rates ◽

Randomized Controlled ◽

Self Help ◽

Self Help Groups

We tested the efficacy of an integrative psychotherapeutic group treatment (IPGT) in reducing vertigo/dizziness-related impairment along with depression, anxiety, and somatization by conducting a randomized controlled superiority trial comparing IPGT to self-help groups moderated by a clinical psychologist (SHG). Adult patients with functional vertigo and dizziness symptoms were randomly allocated to either the IPGT or SHG as active control group. Outcomes were assessed at baseline (t0), after treatment lasting 16 weeks (t1), and 12 months after treatment (t2). A total of 81 patients were assigned to IPGT and 78 patients were assigned to SHG. Vertigo-related impairment was reduced in both conditions (IPGT: t0–t1: d = 1.10, t0–t2: d = 1.06; SHG: t0–t1: d = 0.86, t0–t2: d = 1.29), showing the efficiency of both IPGT and SHG. Clinically relevant improvements were also obtained for depression in both groups. Linear mixed model analyses revealed no differences between groups for all outcomes (effect of group for the primary outcome: b = −1.15, SE = 2.13, t = −0.54, p = 0.59). Attrition rates were higher in SHG (52.6%) than in IPGT (28.4%). Both conditions improved primary and secondary outcomes while IPGT was better accepted by patients than SHG. Trial registration: ClinicalTrials.gov, Identifier: NCT02320851.

Download Full-text

Effectiveness of lidocaine/prilocaine cream on cardiovascular reactions from endotracheal intubation and cough events during recovery period of older patients under general anesthesia: prospective, randomized placebo-controlled study

BMC Geriatrics ◽

10.1186/s12877-020-01567-y ◽

2020 ◽

Vol 20 (1) ◽

Cited By ~ 1

Author(s):

Linsheng Lv ◽

Lei Yan ◽

Xun Liu ◽

Miaoxia Chen

Keyword(s):

Blood Pressure ◽

General Anesthesia ◽

Older Patients ◽

Recovery Period ◽

Test Group ◽

Control Group ◽

Tube Cuff ◽

Group 2 ◽

Lidocaine Prilocaine ◽

Cardiovascular Reactions

Abstract Background Endotracheal intubation is known to pose significant physiological, pharmacokinetic, and dynamic changes and postoperative respiratory complications in patients under general anesthesia. Method An RCT trial was organized by the Third Affiliated Hospital at Sun Yat-sen University, China. Patients were eligible for inclusion in the trial if they were over 60 years old and had upper-abdominal surgery during the induction of anesthesia and had enrolled in endotracheal intubations. The primary end point included cardiovascular reactions during the induction of anesthesia and endotracheal intubations and cough events during the recovery period. In the test group, 2 g of lidocaine/prilocaine cream (and in the control group, 2 g of Vaseline) were laid over the surface of the tracheal tube cuff. Results The systolic blood pressure (F value = 62.271, p < 0.001), diastolic blood pressure (F value = 150.875, p < 0.001), and heart rate (F value = 75.627, p < 0.001) of the test group were significantly lower than the control group. Cough events during the recovery period in the test group were better (spontaneous cough, χ2 value = 10.591, p < 0.001; induced cough, χ2 value =10.806, p < 0.001). Conclusion In older patients, coughing and cardiovascular reactions under anesthesia and endotracheal intubations were reduced, as a result of using lidocaine/prilocaine cream on the surface of the tracheal tube cuff. Trial registration International Clinical Trials Network NCT02017392, 2013-12-16.

Download Full-text

Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial

Trials ◽

10.1186/s13063-021-05333-2 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Lena Violetta Krämer ◽

Nadine Eschrig ◽

Lena Keinhorst ◽

Luisa Schöchlin ◽

Lisa Stephan ◽

...

Keyword(s):

Physical Activity ◽

Randomized Controlled Trial ◽

Mixed Model ◽

Controlled Trial ◽

Control Group ◽

Web Based ◽

Intention To Treat ◽

Randomized Controlled ◽

Link Type

Abstract Background Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectiveness of web-based interventions in university students is low. Our study aims at investigating a web-based intervention for students. The intervention is based on the Health Action Process Approach (HAPA), which discriminates between processes of intention formation (motivational processes) and processes of intention implementation (volitional processes). Primary outcome is change in physical activity; secondary outcomes are motivational and volitional variables as proposed by the HAPA as well as quality of life and depressive symptoms. Methods A two-armed randomized controlled trial (RCT) of parallel design is conducted. Participants are recruited via the internet platform StudiCare (www.studicare.com). After the baseline assessment (t1), participants are randomized to either intervention group (immediate access to web-based intervention) or control group (access only after follow-up assessment). Four weeks later, post-assessment (t2) is performed in both groups followed by a follow-up assessment (t3) 3 months later. Assessments take place online. Main outcome analyses will follow an intention-to-treat principle by including all randomized participants into the analyses. Outcomes will be analysed using a linear mixed model, assuming data are missing at random. The mixed model will include group, time, and the interaction of group and time as fixed effects and participant and university as random effect. Discussion This study is a high-quality RCT with three assessment points and intention-to-treat analysis meeting the state-of-the-art of effectiveness studies. Recruitment covers almost 20 universities in three countries, leading to high external validity. The results of this study will be of great relevance for student health campaigns, as they reflect the effectiveness of self-help interventions for young adults with regard to behaviour change as well as motivational and volitional determinants. From a lifespan perspective, it is important to help students find their way into regular physical activity. Trial registration The German clinical trials register (DRKS) DRKS00016889. Registered on 28 February 2019

Download Full-text

The Use of Telehealth Technology in Assessing the Accuracy of Self-Reported Weight and the Impact of a Daily Immediate-Feedback Intervention among Obese Employees

International Journal of Telemedicine and Applications ◽

10.1155/2011/909248 ◽

2011 ◽

Vol 2011 ◽

pp. 1-6 ◽

Cited By ~ 4

Author(s):

Nicolaas P. Pronk ◽

A. Lauren Crain ◽

Jeffrey J. VanWormer ◽

Brian C. Martinson ◽

Jackie L. Boucher ◽

...

Keyword(s):

Body Weight ◽

Mixed Model ◽

Linear Mixed Model ◽

Controlled Trial ◽

Intervention Group ◽

Study Groups ◽

Outcome Variable ◽

Control Group ◽

Immediate Feedback ◽

The Impact

Objective.To determine the accuracy of self-reported body weight prior to and following a weight loss intervention including daily self-weighing among obese employees.Methods.As part of a 6-month randomized controlled trial including a no-treatment control group, an intervention group received a series of coaching calls, daily self-weighing, and interactive telemonitoring. The primary outcome variable was the absolute discrepancy between self-reported and measured body weight at baseline and at 6 months. We used general linear mixed model regression to estimate changes and differences between study groups over time.Results.At baseline, study participants underreported their weight by an average of 2.06 (se=0.33) lbs. The intervention group self-reported a smaller absolute body weight discrepancy at followup than the control group.Conclusions.The discrepancy between self-reported and measured body weight appears to be relatively small, may be improved through daily self-monitoring using immediate-feedback telehealth technology, and negligibly impacts change in body weight.

Download Full-text

Acute effects of calcium supplements on blood pressure and blood coagulation: secondary analysis of a randomised controlled trial in post-menopausal women

British Journal Of Nutrition ◽

10.1017/s0007114515003694 ◽

2015 ◽

Vol 114 (11) ◽

pp. 1868-1874 ◽

Cited By ~ 18

Author(s):

Sarah M. Bristow ◽

Greg D. Gamble ◽

Angela Stewart ◽

Anne M. Horne ◽

Ian R. Reid

Keyword(s):

Blood Pressure ◽

Blood Coagulation ◽

Controlled Trial ◽

Secondary Analysis ◽

Control Group ◽

Calcium Citrate ◽

Acute Effects ◽

Menopausal Women ◽

Post Menopausal ◽

Randomised Controlled

AbstractRecent evidence suggests that Ca supplements increase the risk of cardiovascular events, but the mechanism(s) by which this occurs is uncertain. In a study primarily assessing the effects of various Ca supplements on blood Ca levels, we also investigated the effects of Ca supplements on blood pressure and their acute effects on blood coagulation. We randomised 100 post-menopausal women to 1 g/d of Ca or a placebo containing no Ca. Blood pressure was measured at baseline and every 2 h up to 8 h after their first dose and after 3 months of supplementation. Blood coagulation was measured by thromboelastography (TEG) in a subgroup of participants (n 40) up to 8 h only. Blood pressure declined over 8 h in both the groups, consistent with its normal diurnal rhythm. The reduction in systolic blood pressure was smaller in the Ca group compared with the control group by >5 mmHg between 2 and 6 h (P≤0·02), and the reduction in diastolic blood pressure was smaller at 2 h (between-groups difference 4·5 mmHg, P=0·004). Blood coagulability, assessed by TEG, increased from baseline over 8 h in the calcium citrate and control groups. At 4 h, the increase in the coagulation index was greater in the calcium citrate group compared with the control group (P=0·03), which appeared to be due to a greater reduction in the time to clot initiation. These data suggest that Ca supplements may acutely influence blood pressure and blood coagulation. Further investigation of this possibility is required.

Download Full-text

Effect of Low-Dose (Single-Dose) Magnesium Sulfate on Postoperative Analgesia in Hysterectomy Patients Receiving Balanced General Anesthesia

Anesthesiology Research and Practice ◽

10.1155/2015/306145 ◽

2015 ◽

Vol 2015 ◽

pp. 1-6 ◽

Cited By ~ 4

Author(s):

Arman Taheri ◽

Katayoun Haryalchi ◽

Mandana Mansour Ghanaie ◽

Neda Habibi Arejan

Keyword(s):

Single Dose ◽

Postoperative Pain ◽

General Anesthesia ◽

Magnesium Sulfate ◽

Pain Score ◽

Normal Saline ◽

Low Dose ◽

Rating Scale ◽

Controlled Trial ◽

Control Group

Background and Aim. Aparallel, randomized, double blinded, placebo-controlled trial study was designed to assess the efficacy of single low dose of intravenous magnesium sulfate on post-total abdominal hysterectomy (TAH) pain relief under balanced general anesthesia.Subject and Methods. Forty women undergoing TAH surgery were assigned to two magnesium sulfate (N=20) and normal saline (N=20) groups randomly. The magnesium group received magnesium sulfate 50 mg·kg−1in 100 mL of normal saline solution i.v as single-dose, just 15 minutes before induction of anesthesia whereas patients in control group received 100 mL of 0.9% sodium chloride solution at the same time. The same balanced general anesthesia was induced for two groups. Pethidine consumption was recorded over 24 hours precisely as postoperative analgesic. Pain score was evaluated with Numeric Rating Scale (NRS) at 0, 6, 12, and 24 hours after the surgeries.Results. Postoperative pain score was lower in magnesium group at 6, 12, and 24 hours after the operations significantly (P<0.05).Pethidinerequirement was significantly lower in magnesium group throughout 24 hours after the surgeries (P=0.0001).Conclusion. Single dose of magnesium sulfate during balanced general anesthesia could be considered as effective and safe method to reduce postoperative pain and opioid consumption after TAH.

Download Full-text

Immediate Effect of Scalp Acupuncture on the Gait of Patients with Subacute Intracerebral Haemorrhage Analysed by Three-Dimensional Motion: Secondary Analysis of a Randomised Controlled Trial

Acupuncture in Medicine ◽

10.1136/acupmed-2016-011272 ◽

2018 ◽

Vol 36 (2) ◽

pp. 71-79 ◽

Cited By ~ 2

Author(s):

Hai-Qiao Wang ◽

Gui-Rong Dong ◽

Chun-Ling Bao ◽

Zhi-Hua Jiao

Keyword(s):

Treatment Group ◽

Acupuncture Treatment ◽

Controlled Trial ◽

Secondary Analysis ◽

Three Dimensional ◽

Scalp Acupuncture ◽

Control Group ◽

Kinematic Parameters ◽

Spatiotemporal Parameters ◽

Randomised Controlled

Objective To investigate the immediate effect of scalp acupuncture on walking pattern, using three-dimensional gait analysis (3D-GA), among patients in the subacute stage of intracerebral haemorrhage (ICH). Methods A subset of 30 patients with subacute ICH participating in a recently published randomised controlled trial who were able to walk independently were assessed by 3D-GA before and immediately after scalp acupuncture treatment (treatment group) or no intervention (control group) and the results presented here as a secondary analysis. The acupuncture manipulation was repeated three times with an interval of 5 min. Spatiotemporal and kinematic parameters during walking were collected and analysed using a 3D motion analysis system. Results After treatment, there were significant differences between the treatment and control groups in the spatiotemporal parameters of step length, velocity and cadence (p<0.05) and double-limb support. No significant difference was found in step width. When kinematic parameters were evaluated, the treatment group showed a significantly decreased peak pelvic anterior tilt angle and an increased hip extension angle after scalp acupuncture treatment, whereas the control group demonstrated no temporal changes. There were no significant changes in any other kinematic parameters in either group. Conclusions As the first exploratory study to investigate the effect of the scalp acupuncture on gait performance in patients with subacute ICH, this secondary analysis of a recent randomised trial suggested an immediate effect of treatment on spatiotemporal parameters. Improvement in gait pattern may be associated with a decreased anterior tilt of the pelvis and augmented hip joint motion during walking. Trial Registration Number ChiCTR-TRC-08000225; Post-results.

Download Full-text