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Effect of a mother's recorded voice on emergence from general anesthesia in pediatric patients: study protocol for a randomized controlled trial.

ABSTRACT: Emergence delirium is a behavioral disturbance after general anesthesia in children and may distress both the patients and the primary caregivers, such as parents and medical staff, looking after the patients. Various medical and emotional interventions have been investigated to reduce emergence delirium; however, none are completely effective. This trial intends to assess whether the mother's recorded voice can reduce this adverse post-anesthesia event and facilitate arousal from general anesthesia.This is a prospective, double-blind, single-center, parallel-arm, superiority, randomized controlled trial to be conducted in participants aged 2-8 years who are undergoing elective surgery requiring general anesthesia. Participants will be randomly assigned to one of two groups: those who are stimulated to wake up by listening to their mother's recorded voice (maternal group, n?=?33) or a stranger's voice (stranger group, n?=?33) during anesthetic emergence. The primary outcome is the initial emergence delirium score in the post-anesthesia care unit (PACU). The secondary outcomes are hemodynamic parameters, including heart rate and mean blood pressure, the duration of time between the cessation of anesthetics and a BIS level of 60, 70 and 80, eye-opening or purposeful movement time, extubation time, total consumption of analgesics, PACU stay time, emergence delirium and pain scores during the PACU stay.This is the first randomized controlled trial to investigate the effect of a mother's recorded voice during emergence on the pediatric emergence profile after general anesthesia. It may provide prophylactic treatment options to decrease emergence delirium and enhance arousal from general anesthesia.ClicnicalTrials.gov, ID: NCT02955680 . Registered on 2 November 2016.

SUBMITTER: Song SY

PROVIDER: S-EPMC5602836 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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Effect of a mother's recorded voice on emergence from general anesthesia in pediatric patients: study protocol for a randomized controlled trial.

Song Seok Young SY Kwak Sang Gyu SG Kim Eugene E

Trials 20170915 1

<h4>Background</h4>Emergence delirium is a behavioral disturbance after general anesthesia in children and may distress both the patients and the primary caregivers, such as parents and medical staff, looking after the patients. Various medical and emotional interventions have been investigated to reduce emergence delirium; however, none are completely effective. This trial intends to assess whether the mother's recorded voice can reduce this adverse post-anesthesia event and facilitate arousal ...[more]

PMID: 28915907

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Project description:BackgroundThe use of a laryngeal mask airway (LMA) in appropriate patients supports fast-track anesthesia with a lower incidence of postoperative airway-connected adverse events. Data on the most favorable anesthetic in this context, with the lowest rate of upper airway complications and fast emergence times, are controversial and limited. Desflurane seems to match these criteria best, but large randomized controlled trials (RCTs) with a standardized study protocol are lacking. Therefore, we aim to compare desflurane with other commonly used anesthetics, sevoflurane and propofol, in a sufficiently powered RCT. We hypothesize that desflurane is noninferior regarding the frequency of upper airway events and superior regarding the emergence times to sevoflurane and propofol.Methods/designA total of 351 patients undergoing surgery with an LMA will be included in this prospective, randomized, double-blind controlled, multicenter clinical trial. The patients will be randomly assigned to the three treatment arms: desflurane (n = 117), sevoflurane (n = 117), and propofol (n = 117). The emergence time (time to state the date of birth) will be the primary endpoint of this study. The secondary endpoints include further emergence times, such as time to open eyes, to remove LMA, to respond to command and to state name. Additionally, we will determine the frequency of cough and laryngospasm, measured intraoperatively and at emergence. We will assess the postoperative recovery on the first postoperative day via the Postoperative Quality Recovery Scale.DiscussionDespite increasing importance of cost-effective and safe anesthesia application, we lack proof for the most advantageous anesthetic agent, when an LMA is used. There are only a few RCTs comparing desflurane to other commonly used anesthetics (sevoflurane, propofol and isoflurane) in patients with LMA. These RCTs were conducted with small sample sizes, huge interstudy variability, and some also showed strong biases. The present multicenter RCT will provide results from a large sample size with a standardized study protocol and minimized bias, which is feasible in the clinical routine. Furthermore, we will expand our knowledge regarding the most favorable recovery on the first postoperative day, which impacts patients' comfort after surgery.Trial registrationEudraCT Identifier: 2014-003810-96, 5 September 2014 ClinicalTrials.gov: NCT02322502, December 2014.

Project description:BackgroundEmergence delirium, a manifestation of acute postoperative brain dysfunction, is frequently observed after pediatric anesthesia and has been associated with the use of sevoflurane. Both xenon and dexmedetomidine possess numerous desirable properties for the anesthesia of children with congenital heart disease, including hemodynamic stability, lack of neurotoxicity, and a reduced incidence of emergence delirium. Combining both drugs has never been studied as a balanced-anesthesia technique. This combination allows the provision of anesthesia without administering anesthetic drugs against which the Food and Drug Administration (FDA) issued a warning for the use in young children.Methods/designIn this phase-II, mono-center, prospective, single-blinded, randomized, controlled pilot trial, we will include a total of 80 children aged 0-3 years suffering from congenital heart disease and undergoing general anesthesia for elective diagnostic and/or interventional cardiac catheterization. Patients are randomized into two study groups, receiving either a combination of xenon and dexmedetomidine or mono-anesthesia with sevoflurane for the maintenance of anesthesia. The purpose of this study is to estimate the effect size for xenon-dexmedetomidine versus sevoflurane anesthesia with respect to the incidence of emergence delirium in children. We will also describe group differences for a variety of secondary outcome parameters including peri-interventional hemodynamics, emergence characteristics, incidence of postoperative vomiting, and the feasibility of a combined xenon-dexmedetomidine anesthesia in children.DiscussionSevoflurane is the most frequently used anesthetic in young children, but has been indicated as an independent risk factor in the development of emergence delirium. Xenon and dexmedetomidine have both been associated with a reduction in the incidence of emergence delirium. Combining xenon and dexmedetomidine has never been described as a balanced-anesthesia technique in children. Our pilot study will therefore deliver important data required for future prospective clinical trials.Trial registrationEudraCT, 2018-002258-56. Registered on 20 August 2018. https://www.clinicaltrialsregister.eu.

Project description:BackgroundEnhanced recovery after surgery (ERAS) is now widely used in various surgical fields including gynecological laparoscopic surgery, but the advantages of opioid-free anesthesia (OFA) in gynecological laparoscopic surgery under ERAS protocol are inexact.AimsThis study aims to assess the effectiveness and feasibility of OFA technique versus traditional opioid-based anesthesia (OA) technique in gynecological laparoscopic surgery under ERAS.MethodsAdult female patients aged 18 ~ 65 years old undergoing gynecological laparoscopic surgery were randomly divided into OFA group (Group OFA, n = 39) with esketamine and dexmedetomidine or OA group (Group OA, n = 38) with sufentanil and remifentanil. All patients adopted ERAS protocol. The primary outcome was the area under the curve (AUC) of Visual Analogue Scale (VAS) scores (AUCVAS) postoperatively. Secondary outcomes included intraoperative hemodynamic variables, awakening and orientation recovery times, number of postoperative rescue analgesia required, incidence of postoperative nausea and vomiting (PONV) and Pittsburgh Sleep Quality Index (PSQI) perioperatively.ResultsAUCVAS was (Group OFA, 16.72 ± 2.50) vs (Group OA, 15.99 ± 2.72) (p = 0.223). No difference was found in the number of rescue analgesia required (p = 0.352). There were no between-group differences in mean arterial pressure (MAP) and heart rate (HR) (p = 0.211 and 0.659, respectively) except MAP at time of surgical incision immediately [(Group OFA, 84.38 ± 11.08) vs. (Group OA, 79.00 ± 8.92), p = 0.022]. Times of awakening and orientation recovery in group OFA (14.54 ± 4.22 and 20.69 ± 4.92, respectively) were both longer than which in group OA (12.63 ± 3.59 and 18.45 ± 4.08, respectively) (p = 0.036 and 0.033, respectively). The incidence of PONV in group OFA (10.1%) was lower than that in group OA (28.9%) significantly (p = 0.027). The postoperative PSQI was lower than the preoperative one in group OFA (p = 0.013).ConclusionIn gynecological laparoscopic surgery under ERAS protocol, OFA technique is non-inferior to OA technique in analgesic effect and intraoperative anesthesia stability. Although awakening and orientation recovery times were prolonged compared to OA, OFA had lower incidence of PONV and improved postoperative sleep quality.Trial registrationChiCTR2100052761, 05/11/2021.

Project description:BackgroundEmergence delirium can occur after general anesthesia in children. An intravenous infusion of alfentanil may reduce the incidence or severity of emergence delirium after sevoflurane anesthesia.ObjectiveThe study aimed to investigate the effects of alfentanil intravenous infusion on emergence delirium and other perioperative complications.MethodThis was a single-center, randomized, placebo-controlled, double-blind clinical trial. A total of 172 children undergoing ambulatory dental treatment were randomized into three groups. Alfentanil group Alf2 received 0.2 μg/kg/min of alfentanil for continuous infusion, alfentanil group Alf4 received 0.4 μg/kg/min alfentanil, and the saline group (group Sal) received a continuous infusion of normal saline, with the same volume as the two other groups, as a placebo. The incidence of emergence delirium (assessed by the Paediatric Anaesthesia Emergence Delirium [PAED] scale), hemodynamic parameters, and recovery characteristics were recorded during the recovery period. The Aono scale was also used to assess for emergence delirium. A WeChat applet was designed to facilitate a caregiver teleconsultation and to provide feedback on postoperative nausea and vomiting and any other complications after discharge.ResultsThe incidence of emergence delirium in group Alf2 (22.9%) and group Alf4 (21.1%) was significantly lower than that observed in the Sal group (48.3%). The PAED scores in group Alf2 (6.4 ± 3.5) and group Alf4 (5.8 ± 3.8) were significantly lower than those for group Sal (9.6 ± 5.1) (p < 0.01). Ten children in the Alf4 group needed manual ventilatory assistance to maintain end-tidal carbon dioxide (ETCO2) < 55 mm; children in group Alf2 did not. There was no significant difference between the discharge time of groups Alf2 and Sal (31.2 ± 4.64 vs 30.5 ± 2.82 min; 0.659 [95% confidence interval {CI} -1.052 to 2.369], p = 0.643); the time to discharge of group Alf4 (35.16 ± 3.97 min) was significantly longer than that of groups Alf2 and Sal (p < 0.01). The incidence of nausea and vomiting was similar in the three groups. No other clinically relevant adverse events were observed.ConclusionsIntravenous infusion of 0.2 μg/kg/min and 0.4 μg/kg/min alfentanil decreased the incidence of emergence delirium in the post-anesthesia care unit. The 0.2 μg/kg/min dose of alfentanil resulted in less respiratory depression and discharge delay than the 0.4 μg/kg/min alfentanil dose.Trial registrationChinese Clinical Trial Registry (ChiCTR2100043320).

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

Effect of a mother's recorded voice on emergence from general anesthesia in pediatric patients: study protocol for a randomized controlled trial.

Publications

Effect of a mother's recorded voice on emergence from general anesthesia in pediatric patients: study protocol for a randomized controlled trial.

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