Dataset Information

Effect of xenon and dexmedetomidine as adjuncts for general anesthesia on postoperative emergence delirium after elective cardiac catheterization in children: study protocol for a randomized, controlled, pilot trial.

ABSTRACT:

Background

Emergence 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/design

In 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.

Discussion

Sevoflurane 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 registration

EudraCT, 2018-002258-56. Registered on 20 August 2018. https://www.clinicaltrialsregister.eu.

SUBMITTER: Devroe S

PROVIDER: S-EPMC7126401 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effect of xenon and dexmedetomidine as adjuncts for general anesthesia on postoperative emergence delirium after elective cardiac catheterization in children: study protocol for a randomized, controlled, pilot trial.

Devroe Sarah S Devriese Lisa L Debuck Frederik F Fieuws Steffen S Cools Bjorn B Gewillig Marc M Van de Velde Marc M Rex Steffen S

Trials 20200403 1

<h4>Background</h4>Emergence 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-anesthes ...[more]

PMID: 32245513

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Project description:Children with cerebral palsy can demonstrate irritability following emergence from general anaesthesia. As well, an elevated rate of emergence delirium (ED) in children has been associated with the application of sevoflurane. The current study's intent is to administer dexmedetomidine, in a single dosage administration, at the initial phase of sevoflurane based anesthesia with regard to the occurrence and severity of ED in children afflicted with cerebral palsy. Participating in the study (American Society of Anesthesiologists I-II) are eighty children ranging in ages two through twelve years. They would be anaesthetised with sevoflurane based anesthesia while undergoing lower limb surgical procedures. The participants were equally distributed to either Group c or Group D. Group C was administered 10 ml saline 0.9%, and Group D was administered dexmedetomidine 0.5 μg•kg(-1). Five minutes prior to commencement of the surgical procedures, the participants received the prescribed pharmaceutical dosages under the anesthesia of sevoflurane. In order to sustain the BIS values in a range of 45 and 55, at 60 second increments, endtidal sevoflurane concentrations (ETsev) were modified. After conclusion of the surgical procedures, in post anesthesia care unit (PACU), the frequency of ED was gauged with Aonos four point scale and the severity of ED was gauged with pediatric anesthesia emergence delirium scale upon admission (T0), after intervals of five minutes (T5), fifteen minutes (T15) and thirty minutes (T30). Extubation time, emergence time and length of at stay at the PACU were assessed. Relative to Group C, participants of Group D exhibited noticeably shortened times of emergence, extubation and PACU duration of stay. Prior to surgical incision, ETsev was elevated in the control group, (1.9±0.2 vs 1.6±0.3; P = 0.023) and amid the initial 20 minutes following the surgical incision (1.6±0.2 vs 1.1±0.2; P = 0.016). At intervals of commencement, T0, of five minutes (T5) and fifteen minutes T15, Group D exhibited lower occurrences and severity of ED than those participants in Group C. Dexmedetomidine, given as a bolus dose post induction, was effective in reducing the occurrence and severity of emergence delirium in children with cerebral palsy who were undergoing lower limb surgical procedures under sevoflurane anaesthesia.

Project description:Background:Several studies have identified side effects of general anesthesia with endotracheal intubation, such as laryngeal pain, dysphonia, and postoperative nausea and vomiting (PONV). The laryngeal mask airway (LMAw) is believed to decrease these side effects. The aim of this trial was to compare postoperative discomfort, emergence delirium, and recovery time of patients who received either an LMAw or nasotracheal intubation (NTI). Patients and methods:A total of 70 children were randomly assigned to the LMAw group (n=35) or the NTI group (n=35). Both groups underwent mask induction with 8% sevoflurane. The NTI group received muscle relaxant, whereas the LMAw group did not. Postoperative laryngeal pain, dental pain, dysphonia, and PONV were assessed immediately and at 1 hour and 6 hours postoperatively. The Wong-Baker Faces Scale was used to evaluate the patients' self-reported pain. In addition, decayed, missing, and filled teeth (dft/DMFT) values, dental procedure type, number of dental procedures, duration of the dental operation, duration of anesthesia, recovery time, emergence delirium, pediatric dentist's access to the mouth, and parents' satisfaction levels were recorded. Data were analyzed using descriptive statistics, chi-square tests, and two-sample t-tests. Results:The incidence of postoperative laryngeal pain was significantly higher in the NTI group immediately (97.2% vs. 8.5%, P=0.00), 1 hour (94.2% vs. 0%, P=0.00), and 6 hours postoperatively (25.7% vs. 0%, P=0.00). There were no statistically significant differences between the two groups in dental pain scores, dft/DMFT values, duration of anesthesia, duration of the dental operation, number of dental procedures, the incidence of PONV, or pediatric dentist's access to the mouth (P>0.05). Emergence delirium and recovery time were significantly higher in the NTI group (P<0.05). Conclusion:The LMAw provided a more comfortable postoperative period than NTI for children who underwent full-mouth dental rehabilitation under general anesthesia.

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).

Dataset Information

Effect of xenon and dexmedetomidine as adjuncts for general anesthesia on postoperative emergence delirium after elective cardiac catheterization in children: study protocol for a randomized, controlled, pilot trial.

Background

Methods/design

Discussion

Trial registration

Publications

Effect of xenon and dexmedetomidine as adjuncts for general anesthesia on postoperative emergence delirium after elective cardiac catheterization in children: study protocol for a randomized, controlled, pilot trial.

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