Dataset Information

Impact of dexmedetomidine supplemented analgesia on delirium in patients recovering from orthopedic surgery: A randomized controlled trial.

ABSTRACT:

Background

Dexmedetomidine promotes normal sleep architecture; the drug also improves analgesia. We therefore tested the hypothesis that supplementing intravenous analgesia with dexmedetomidine reduces delirium in older patients recovering from orthopedic surgery.

Methods

In this double-blinded randomized controlled trial, we enrolled 712 older (aged 65-90 years) patients scheduled for major orthopedic surgery. Postoperative analgesia was provided by patient-controlled intravenous sufentanil, supplemented by randomly assigned dexmedetomidine (1.25 μg/mL) or placebo, for up to three days. The primary outcome was the incidence of delirium assessed twice daily with the Confusion Assessment Method. Among secondary outcomes, pain severity was assessed twice daily and sleep quality once daily, each with an 11-point scale where 0 = no pain/the best possible sleep and 10 = the worst pain/the worst possible sleep.

Results

The incidence of postoperative delirium was 7.3% (26 of 354) with placebo and 4.8% (17 of 356) with dexmedetomidine; relative risk 0.65, 95% CI 0.36 to 1.18; P = 0.151. Dexmedetomidine reduced pain both at rest (median difference -1 to 0 points, P ≤ 0.001) and with movement (-1 points, P < 0.001) throughout the first 5 postoperative days; it also improved subjective sleep quality during the first 3 postoperative days: day one median difference -1 point (95% CI -1 to 0), P = 0.007; day two 0 point (-1 to 0), P = 0.010; and day three 0 point (-1 to 0), P = 0.003. The incidence of adverse events was similar in each group.

Conclusions

Supplementing sufentanil intravenous analgesia with low-dose dexmedetomidine did not significantly reduce delirium, but improved analgesia and sleep quality without provoking adverse events.

Trial registration

www.chictr.org.cn : ChiCTR1800017182 (Date of registration: July 17, 2018); ClinicalTrials.gov: NCT03629262 (Date of registration: August 14, 2018).

SUBMITTER: Hong H

PROVIDER: S-EPMC8435562 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature

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Publications

Impact of dexmedetomidine supplemented analgesia on delirium in patients recovering from orthopedic surgery: A randomized controlled trial.

Hong Hong H Zhang Da-Zhi DZ Li Mo M Wang Geng G Zhu Sai-Nan SN Zhang Yue Y Wang Dong-Xin DX Sessler Daniel I DI

BMC anesthesiology 20210913 1

<h4>Background</h4>Dexmedetomidine promotes normal sleep architecture; the drug also improves analgesia. We therefore tested the hypothesis that supplementing intravenous analgesia with dexmedetomidine reduces delirium in older patients recovering from orthopedic surgery.<h4>Methods</h4>In this double-blinded randomized controlled trial, we enrolled 712 older (aged 65-90 years) patients scheduled for major orthopedic surgery. Postoperative analgesia was provided by patient-controlled intravenous ...[more]

PMID: 34517840

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Project description:BackgroundDelirium is a frequent complication after cardiac surgery and its occurrence is associated with poor outcomes. The purpose of this study was to investigate the impact of perioperative dexmedetomidine administration on the incidence of delirium in elderly patients after cardiac surgery.MethodsThis randomized, double-blinded, and placebo-controlled trial was conducted in two tertiary hospitals in Beijing between December 1, 2014 and July 19, 2015. Eligible patients were randomized into two groups. Dexmedetomidine (DEX) was administered during anesthesia and early postoperative period for patients in the DEX group, whereas normal saline was administered in the same rate for the same duration for patients in the control (CTRL) group. The primary endpoint was the incidence of delirium during the first five days after surgery. Secondary endpoints included the cognitive function assessed on postoperative days 6 and 30, the overall incidence of non-delirium complications within 30 days after surgery, and the all-cause 30-day mortality.ResultsTwo hundred eighty-five patients were enrolled and randomized. Dexmedetomidine did not decrease the incidence of delirium (4.9% [7/142] in the DEX group vs 7.7% [11/143] in the CTRL group; OR 0.62, 95% CI 0.23 to 1.65, p = 0.341). Secondary endpoints were similar between the two groups; however, the incidence of pulmonary complications was slightly decreased (OR 0.51, 95% CI 0.26 to 1.00, p = 0.050) and the percentage of early extubation was significantly increased (OR 3.32, 95% CI 1.36 to 8.08, p = 0.008) in the DEX group. Dexmedetomidine decreased the required treatment for intraoperative tachycardia (21.1% [30/142] in the DEX group vs 33.6% [48/143] in the CTRL group, p = 0.019), but increased the required treatment for postoperative hypotension (84.5% [120/142] in the DEX group vs 69.9% [100/143] in the CTRL group, p = 0.003).ConclusionsDexmedetomidine administered during anesthesia and early postoperative period did not decrease the incidence of postoperative delirium in elderly patients undergoing elective cardiac surgery. However, considering the low delirium incidence, the trial might have been underpowered.Trial registrationClinicalTrials.gov NCT02267538.

Project description:BackgroundAdministration of adjuvant drugs epidurally in combination with local anesthetics offers new dimensions in the management of postoperative pain. This study aimed to compare the addition of either nalbuphine or dexmedetomidine to epidural bupivacaine for postoperative analgesia in lower limb orthopedic surgeries under combined spinal-epidural anesthesia.MethodsThis prospective randomized double-blind study included 69 patients scheduled for lower limb orthopedic surgeries. Anesthesia was started with 15 mg hyperbaric bupivacaine 0.5% intrathecally, and then an epidural bolus dose of 12 ml (10 ml 0.25% bupivacaine with 2 ml normal saline in group C, 2 ml (10 mg) nalbuphine in group N or dexmedetomidine 2 ml (100 µg) in group D was administered when sensory regression to T10. Postoperatively, when visual analogue scale (VAS) was ≥ 3, an epidural top-up dose of 8 ml (6 ml 0.25% bupivacaine plus 2 ml normal saline in group C, 2 ml (2 mg) nalbuphine in group N or 20 µg dexmedetomidine (2 ml) in group D was given. The primary outcome was to evaluate the duration of postoperative analgesia and secondary outcomes were any side effects and patient satisfaction.ResultsThe onset of epidural analgesia was 17.83 ± 2.53 versus 13.39 ± 1.27 versus 12.17 ± 1.27 min in groups C, N and D, respectively (p value < 0.001). The mean duration of analgesia was 241.3 ± 14.24 versus 318.38 ± 22.54 versus 365.87 ± 18.01 min in groups C, N and D, respectively (p value < 0.001). The mean sedation score was less in group C than group N and D (P < 0.001). The patient satisfaction score showed the lowest degree of satisfaction in group C (p value < 0.001). Top-up doses consumed and total analgesic requirements were lower in groups N and D than in group C. There was a statistically significant difference between the studied groups regarding VAS over time (p value < 0.001), intraoperative bradycardia (p value 0.029), and shivering (p value 0.029).ConclusionThe addition of either nalbuphine or dexmedetomidine to epidural bupivacaine was effective for postoperative analgesia in terms of onset, duration, and patient satisfaction with the superiority of dexmedetomidine over nalbuphine.Trial registrationApproval from the research ethics committee of the Faculty of Medicine, Zagazig University was obtained with the reference number (ZU-IRB#:7045-15-8-2021) and it was registered under clinicaltrials.gov (NCT05041270) on registration date 13/09/2021.

Project description:BackgroundThe medical community is beginning to recognize the contribution of prescription opioids in the growing national opioid crisis. Many studies have compared the safety and efficacy of alternative analgesics to opioids, but none utilizing a completely opioid-free perioperative protocol in orthopedics.MethodsWe developed and tested an opioid-free perioperative analgesic pathway (from preoperative to postoperative period) among patients undergoing common elective orthopedic procedures. Patients will be randomized to receive either traditional opioid-including or completely opioid-free perioperative medications. This study is being conducted across multiple orthopedic subspecialties in patients undergoing the following common elective orthopedic procedures: single-level or two-level ACDF/ACDA, 1st CMC arthroplasty, Hallux Valgus/Rigidus corrections, diagnostic knee arthroscopies, total hip arthroplasty (THA), and total shoulder arthroplasty/reverse total shoulder arthroplasty (TSA/RTSA). The primary outcome measure is pain score at 24 h postoperatively. Secondary outcome measures include pain scores at additional time points, medication side effects, and several patient-reported variables such as patient satisfaction, quality of life, and functional status.DiscussionWe describe the methods for a feasibility randomized controlled trial comparing opioid-free perioperative analgesics to traditional opioid-including protocols. We present this study so that it may be replicated and incorporated into future studies at other institutions, as well as disseminated to additional orthopedic and/or non-orthopedic surgical procedures. The ultimate goal of presenting this protocol is to aid recent efforts in reducing the impact of prescription opioids on the national opioid crisis.Trial registrationThe protocol was approved by the local institutional review board and registered with clinicaltrials.gov (Identifier: NCT04176783 ) on November 25, 2019, retrospectively registered.

Project description:BackgroundThe reciprocal nexus between sleep and pain is well-documented, with the deleterious impact of operative trauma potentially playing a pivotal role in the dysregulation of this interplay, which could significantly contribute to the manifestation of postoperative delirium (POD). Studies have investigated the effect of adding dexmedetomidine (DEX) to patient-controlled intravenous analgesia (PCIA) pumps on postoperative pain-sleep interaction cycle and POD, but conclusions remained uncertain. The objective of this investigation is to perform a meta-analysis that thoroughly assesses the impact of integrating DEX into PCIA, focusing on analgesic effectiveness, sleep quality, and the incidence of delirium in postoperative patients.MethodsPubMed, Embase, Cochrane Library, SinoMed, and Wanfang Data Knowledge Service Platform were searched, for publications in any language, from database inception to September 2023. Our analysis encompassed randomized controlled trials (RCTs) that examine the therapeutic efficacy and risk profile of adding DEX to the PCIA on the postoperative pain-sleep interaction cycle, by focusing on changes in postoperative analgesia (Visual analog scale (VAS) score), sleep efficiency, sleep structure, subjective sleep score (Assen insomnia scale and numerical rating scale) and adverse event rate.Results34 RCTs (4324 patients) were analyzed. This study shows DEX improved analgesia and reduced VAS scores at 6, 12, and 24 h after surgery. Sleep efficiency was enhanced on the 1st and 2nd postoperative night. DEX improved sleep structure at the 1st postoperative night by reducing non-rapid eye movement stage 1 (N1) sleep and increasing non-rapid eye movement stage 2 (N2) and non-rapid eye movement stage 3 (N3) sleep. At the 2nd night, DEX reduced N1 sleep and increased N2 sleep, but not N3 sleep. Data from AIS and NRS showed improvement in subjective sleep scores on the 1st postoperative night and 2nd night. Additionally, DEX decreased the occurrence of POD on the 24 h and first-three days.ConclusionThis study shows that the typical DEX doses added to PCIA with sufentanil were 2-5 μg/kg or approximately 200-250 μg, and the addition of DEX to PCIA can improve pain-sleep interaction cycle from multiple perspectives, and further decrease the occurrence of POD.

Dataset Information

Impact of dexmedetomidine supplemented analgesia on delirium in patients recovering from orthopedic surgery: A randomized controlled trial.

Background

Methods

Results

Conclusions

Trial registration

Publications

Impact of dexmedetomidine supplemented analgesia on delirium in patients recovering from orthopedic surgery: A randomized controlled trial.

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