Dataset Information

Comparing the effects of dexmedetomidine versus propofol on the treatment of emergence agitation in adult patients after general anesthesia: study protocol for a randomized, superiority, controlled trial (DP-TEA Trial)

ABSTRACT:

Background

Emergence agitation (EA) after general anesthesia is a common complication in the post-anesthesia care unit (PACU). Once EA occurs, there are still no guidelines established for the treatment in adults. Propofol is excessively used in managing agitated patients in the PACU, but it lacks analgesia and can result in apnea. Intraoperative infusion of dexmedetomidine has been proven to have a preventive effect on EA, but the treatment effect of dexmedetomidine on EA remains unknown. This study aims to compare the effects between dexmedetomidine and propofol on relieving EA in adult patients after general anesthesia in the PACU.

Methods

In this randomized, superiority, controlled clinical study, a total of 120 adult patients aged 18–65 years of both genders, with American Society of Anesthesiologists (ASA) classification I or II developing EA in the PACU after general anesthesia, will be enrolled. Patients will be randomized at a 1:1 ratio into two groups, receiving either a single dose of dexmedetomidine (0.7μg/kg) or propofol (0.5 mg/kg). The primary outcome is the proportion of patients having a recurrent EA within 15 min after intervention in the PACU.

Discussion

Previous studies have focused on premedication for preventing EA, while therapeutics for reliving EA have rarely been reported. To our knowledge, this study is the first randomized, superiority, controlled trial to compare a bolus of dexmedetomidine with the current routine care for this indication.

Trial registration

ClinicalTrials.govNCT04142840. Registered on October 26, 2019

Supplementary Information

The online version contains supplementary material available at 10.1186/s13063-021-05743-2.

Background

Methods

Discussion

Trial registration

ClinicalTrials.govNCT04142840. Registered on October 26, 2019

Supplementary Information

The online version contains supplementary material available at 10.1186/s13063-021-05743-2.

SUBMITTER: Feng Z

PROVIDER: S-EPMC8593636 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:The objective of this article is to evaluate the effect of dexmedetomidine on emergence agitation (EA) and recovery profiles in children after sevoflurane anesthesia and its pharmacological mechanisms. Standard bibliographic databases, including MEDLINE, EMBASE, PsycINFP, Springer and ISI Web of Knowledge, were artificially searched to identify all randomized controlled trials (RCTs) comparing the impact of dexmedetomidine with placebo, fentanyl and midazolam on EA and recovery profiles after sevoflurane anesthesia in post-anesthesia care unit (PACU). Two authors assessed the quality of each study independently in accordance with strict inclusion criteria and extracted data. RevMan 5.0 software was applied for performing statistic analysis. The outcomes analyzed included: 1) incidence of EA, 2) emergence time, 3) time to extubation, 4) incidence of post-operation nausea and vomiting, 5) number of patients requiring an analgesic, and 6) time to discharge from PACU. A total of 1364 patients (696 in the dexmedetomidine group and 668 in the placebo, fentanyl and midazolam group) from 20 prospective RCTs were included in the meta-analysis. Compared with placebo, dexmedetomidine decreased the incidence of EA (risk ratio [RR] 0.37; 95% CI 0.30 to 0.46), incidence of nausea and vomiting (RR 0.57; 95% CI 0.38 to 0.85) and number of patients requiring an analgesic (RR 0.43; 95% CI 0.31 to 0.59). However, dexmedetomidine had a significantly delayed effect on the emergence time (weighted mean differences [WMD] 1.16; 95% CI 0.72 to 1.60), time to extubation (WMD 0.61; 95% CI 0.27 to 0.95), and time to discharge from recovery room (WMD 2.67; 95% CI 0.95 to 4.39). Compared with fentanyl (RR 1.39; 95% CI 0.78 to 2.48) and midazolam (RR 1.12; 95% CI 0.54 to 2.35), dexmedetomidine has no significantly difference on the incidence of EA. However, the analgesia effect of dexmedetomidine on postoperation pain has no significantly statistical differences compared with fentanyl (RR 1.12; 95% CI 0.66 to 1.91), which implied that its analgesia effect might play an important role in decreasing the incident of EA. No evidence of publication bias was observed.

Project description:The aim of the present study was to observe whether dexmedetomidine (DEX) combined with sufentanil decreased emergence agitation (EA) in children receiving sevoflurane anesthesia for cleft palate repair surgery. Children undergoing elective cleft palate repair surgery were randomly allocated into the DEX + sufentanil group (group DS; n=50) and the normal saline + fentanyl group (group SF; n=50). Patients in group DS were treated with 0.5 µg/kg DEX prior to induction of anesthesia, whereas patients in group SF received an equal volume of normal saline. Sufentanil (0.2 µg/kg) was administered to induce anesthesia, and 30 min before the end of surgery for patients in group DS. Fentanyl (2 µg/kg) was administered at the same time point for patients in group SF. Mean arterial pressure (MAP), heart rate (HR), duration of surgery and anesthesia, and the dosage of remifentanil were assessed. EA score, Pediatric Anesthesia Emergence Delirium (PAED) score and the Children and Infants Postoperative Pain Scale (CHIPPS) score were documented every 15 min in the post-anesthesia care unit (PACU). The number of cases requiring fentanyl (1 µg/kg) and the recovery profile data were analyzed. Compared with group DS (P<0.05) and the baseline (P<0.05), HR and MAP were significantly increased in group SF immediately following tracheal intubation and extubation. Mean values of maximum EA, PAED and CHIPPS scores were significantly reduced in group DS compared with group SF at 0 (P<0.01), 15 (P<0.05), and 30 min (P<0.05) after arrival at PACU. The incidence of EA in group SF was significantly increased compared with group DS (P<0.05). The dosage of remifentanil during the surgery and the number of cases requiring fentanyl (1 µg/kg) in group DS were significantly decreased compared with group SF (P<0.05). The findings of the present study suggested that DEX combined with sufentanil was able to effectively decrease the incidence of EA in children receiving sevoflurane anesthesia for cleft palate repair surgery.

Project description:Background: We conducted this systematic review and meta-analysis to investigate the clinical effect of dexmedetomidine in preventing pediatric emergence agitation (EA) or delirium (ED) following anesthesia compared with placebo or other sedatives. Methods: The databases of Pubmed, Embase, and Cochrane Library were searched until 8th January 2020. Inclusion criteria were participants with age<18 years and studies of comparison between dexmedetomidine and placebo or other sedatives. Exclusion criteria included adult studies; duplicate publications; management with dexmedetomidine alone; review or meta-analysis; basic research; article published as abstract, letter, case report, editorial, note, method, or protocol; and article presented in non-English language. Results: Fifty-eight randomized controlled trials (RCTs) and five case-control trials (CCTs) including 7,714 patients were included. The results showed that dexmedetomidine significantly decreased the incidence of post-anesthesia EA or ED compared with placebo [OR = 0.22, 95% CI: (0.16, 0.32), I 2 = 75, P < 0.00001], midazolam [OR = 0.36, 95% CI: (0.21, 0.63), I 2 = 57, P = 0.0003], and opioids [OR = 0.55, 95% CI: (0.33, 0.91), I 2 = 0, P = 0.02], whereas the significant difference was not exhibited compared with propofol (or pentobarbital) [OR = 0.56, 95% CI: (0.15, 2.14), I 2 = 58, P = 0.39], ketamine [OR = 0.43, 95% CI: (0.19, 1.00), I 2 = 0, P = 0.05], clonidine [OR = 0.54, 95% CI: (0.20, 1.45), P = 0.22], chloral hydrate [OR = 0.98, 95% CI: (0.26, 3.78), P = 0.98], melatonin [OR = 1.0, 95% CI: (0.13, 7.72), P = 1.00], and ketofol [OR = 0.55, 95% CI: (0.16, 1.93), P = 0.35]. Conclusion: Compared with placebo, midazolam, and opioids, dexmedetomidine significantly decreased the incidence of post-anesthesia EA or ED in pediatric patients. However, dexmedetomidine did not exhibit this superiority compared with propofol and ketamine. With regard to clonidine, chloral hydrate, melatonin, and ketofol, the results needed to be further tested due to the fact that only one trial was included for each control drug.

Project description:BackgroundThe incidence of restlessness in the wake-up period of sevoflurane inhalation anesthesia is high. Although many studies have explored the relationship between dexmedetomidine and restlessness in the wake-up period of sevoflurane anesthesia in children, they can't keep consistent conclusions and lack evidence-based medical evidence. Meta-analysis was conducted to explore the efficacy and safety of dexmedetomidine in the treatment of restlessness during the recovery period of sevoflurane anesthesia in children, and to provide reference for clinic.MethodsRelevant articles were retrieved from PubMed, Embase, MEDLINE, Science Direct, The Cochrane Library, the Chinese National Knowledge Infrastructure (CNKI), Wanfang Database, the Chinese Science and Technology Periodical Database, and the Chinese BioMedical Literature Database (CBM). The Chinese and English search keywords included "dexmedetomidine", "children", "sevoflurane", and "emergence agitation". The articles included were independently evaluated and cross-checked by 2 professionals in strict accordance with the 5 evaluation criteria for randomized controlled trials (RCTs) in the Cochrane Handbook for Systematic Reviews of Interventions (version 5.0.1).ResultsA total of 16 articles were included in this meta-analysis. Of the 16 RCTs, 14 described the generation of random sequences in detail, 8 described allocation concealment in detail, no patient blinding was described due to different surgical methods, 8 articles used operator blinding, and all 16 articles had complete outcome measures. The incidence of emergence agitation in the 0.5 µg/kg dexmedetomidine group was significantly lower than that in the control group, and the difference was statistically significant [odds ratio (OR) =0.22, 95% CI: 0.13, 0.40, P<0.00001]. The incidence of analgesic rescue in the experimental group was significantly lower than that in the control group, and the difference was statistically significant (OR =0.29, 95% CI: 0.13, 0.63, Z =3.13, P=0.002). The incidence of postoperative nausea and vomiting in the experimental group was significantly lower than that in the control group, and the difference was statistically significant (OR =0.33, 95% CI: 0.20, 0.55, Z =4.29, P<0.0001).DiscussionThe results of this meta-analysis confirmed that dexmedetomidine could reduce the incidence of emergence agitation, postoperative analgesic rescue, and nausea and vomiting in children after sevoflurane anesthesia.

Project description:ObjectivesEmergence agitation is a negative behavior commonly recorded after pediatric tonsillectomy. We investigated the efficacy of preoperative premedication with oral transmucosal buccal dexmedetomidine on the incidence and severity of emergence agitation in preschool children undergoing tonsillectomy under sevoflurane anesthesia.MethodsNinety patients aged (3-6 years), ASA I-II were enrolled into three groups (n = 30) to receive oral transmucosal dexmedetomidine 0.5 μg.kg-1 (Group DEX I), 1 μg.kg-1 (Group DEX II) or saline placebo (Group C). Our primary endpoint was the Watcha agitation score at emergence in PACU. Secondary outcomes were preoperative sedation score, intraoperative hemodynamics, postoperative Objective Pain Scale (OPS) and adverse effects.ResultsThe patients' demographics, preoperative sedation scores and extubation time showed no difference between groups. Significant differences between groups in incidence and frequency distribution of each grade of Watcha score were evident at 5 minutes (p = 0.007), 10 minutes (p = 0.034), 30 minutes (p = 0.022), 45 minutes (p = 0.034) and 60 minutes (p = 0.026), postoperatively with significant differences between DEX I and II groups. DEX groups showed lower OPS scores at 5 minutes (p = 0.011), 10 minutes (p = 0.037) and 30 minutes (p = 0.044) after arrival at PACU, with no difference between DEX I and II groups. Patients in DEX II group exhibited lower intraoperative mean heart rate at 15 minutes (p = 0.020), and lower mean arterial pressure at 30 minutes, (p = 0.040), 45 minutes (p = 0.002) and 60 minutes (p = 0.006) with no significant differences between groups in other time points.ConclusionThis study demonstrates the clinical advantage and the simple technique of oral transmucosal DEX premedication for emergence agitation in preschool children undergoing tonsillectomy under sevoflurane anesthesia compared with saline placebo.Trial registrationClinical Trials.gov trial registry: NCT02720705.

Project description:Background: Propofol injection pain, despite various interventions, still occurs during the anesthesia induction and causes intense discomfort and anxiety in patients. This study aimed to explore the effect of intravenous dexmedetomidine on propofol injection pain prior to anesthesia induction with propofol at 4°C. Methods: A total of 251 patients (American Society of Anesthesiologists I-II) who underwent oral and maxillofacial surgery were randomly assigned to a combination group (n = 63), lidocaine group (n = 62), dexmedetomidine group (n = 63), and placebo-control group (n = 63); they received 0.5 ug/kg dexmedetomidine prior to anesthesia induction with propofol at 4°C, 40 mg lidocaine, 0.5 ug/kg dexmedetomidine prior to anesthesia induction, and normal saline, respectively. Incidence of pain, pain intensity, and reaction to the pain stimulus were evaluated by using verbal categorial scoring (VCS), a numerical rating scale (NRS), and the Surgical Pleth Index (SPI), respectively. In addition, hemodynamic parameters such as heart rate (HR) and mean arterial pressure (MAP) were also measured. The VCS and NRS were evaluated at 5 s after propofol injection. In addition, SPI, HR, and MAP were evaluated at three time points (before anesthesia induction and 5 and 30 s after propofol injection). Results: The incidence of pain in the combination group (51%) was significantly lower than that in the lidocaine group (71%), dexmedetomidine group (67%), or placebo-control group (94%) (p < 0.001). VCS and NRS scores in the combination group were also lower compared with the other three groups (p < 0.001), with no statistically significant differences between the lidocaine group and dexmedetomidine group (p > 0.05). The SPI of the combination group decreased significantly in comparison with the other three groups at 5 s after propofol injection (F = 96.23, p < 0.001) and 30 s after propofol injection (F = 4.46, p = 0.005). Further comparisons between HR and MAP revealed no significant differences across the groups (p > 0.05). Conclusion: Because of the sedative nature of dexmedetomidine and analgesic effect of low temperature, this study showed that intravenous dexmedetomidine prior to anesthesia induction with propofol at 4°C is highly effective in attenuating the incidence and severity of pain during injection compared with lidocaine (40 mg), dexmedetomidine 0.5 ug/kg) and placebo. This approach was not associated with any anesthesia complications. Clinical Trial Registration: ClinicalTrials.gov, identifier: ChiCTR-2000034663.

Project description:Background: Emergence agitation (EA) is one of the most common and intractable postoperative complications among children undergoing surgery under general anesthesia. Dexmedetomidine, an α(2)-adrenoceptor agonist, offers an ideal sedation, reduces preoperative anxiety, and facilitates smooth induction of anesthesia, and it is widely used in pediatric surgery. We aimed to evaluate the efficacy of dexmedetomidine for preventing emergence agitation in children after general anesthesia. Methods: We comprehensively reviewed PubMed, Cochrane Library, EMBASE, and Web of Science databases to search all randomized controlled trials, published before April 22, 2020, investigating the efficacy of dexmedetomidine in preventing the emergence agitation in children after general anesthesia. The meta-analysis was performed using Review Manager 5.3. The primary outcome was the incidence of emergence agitation. Secondary outcomes included the number of patients requiring rescue analgesic, number of patients with postoperative nausea and vomiting, emergence time, extubation time, and time to discharge from the post-anesthesia care unit. Results: We included a total of 33 studies, comprising 2,549 patients in this meta-analysis. Compared with saline, dexmedetomidine significantly reduced the emergence agitation incidence [risk ratio (RR) 0.29; 95% confidence interval (CI) 0.22-0.37; p < 0.00001], incidence of postoperative nausea and vomiting (RR 0.46; 95% CI 0.3-0.69; p = 0.0002), and the requirement of rescue analgesic (RR 0.29; 95% CI 0.18-0.44; p < 0.00001). Furthermore, children in the dexmedetomidine group experienced a longer emergence time [mean difference (MD) 2.18; 95% CI 0.81-3.56; p = 0.002] and extubation time (MD 0.77; 95% CI 0.22-1.31; p = 0.006) compared with those in the saline group. However, no significant difference was observed in the time to discharge from the post-anesthesia care unit (MD 2.22; 95% CI -2.29-6.74; p = 0.33) between the two groups. No significant differences were observed between the effects of dexmedetomidine and other drugs like midazolam, propofol, fentanyl, tramadol, and clonidine in terms of the emergence agitation incidence and other parameters, except for the requirement of rescue analgesic (RR 0.45; 95% CI 0.33-0.61; p < 0.00001). Conclusions: Dexmedetomidine can prevent emergence agitation, relieves postoperative pain, decreases the requirement of rescue analgesic, and decreases the postoperative nausea and vomiting events.

Dataset Information

Comparing the effects of dexmedetomidine versus propofol on the treatment of emergence agitation in adult patients after general anesthesia: study protocol for a randomized, superiority, controlled trial (DP-TEA Trial)

Background

Methods

Discussion

Trial registration

Supplementary Information

Background

Methods

Discussion

Trial registration

Supplementary Information

Similar Datasets

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