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The effect of remimazolam-based total intravenous anesthesia versus sevoflurane-based inhalation anesthesia on emergence delirium in children undergoing tonsillectomy and adenoidectomy: study protocol for a prospective randomized controlled trial.

ABSTRACT: Background: Remimazolam, a new ultrashort-acting benzodiazepine, is becoming increasingly applied in general anesthesia. This study is designed to investigate the effect of remimazolam-based total intravenous anesthesia and sevoflurane-based inhalation anesthesia on emergence delirium in pediatric tonsillectomy and adenoidectomy. Methods and analysis: This is a monocentric, prospective, randomized, double-blind clinical trial. A total of 90 pediatric patients will be randomized to receive remimazolam-based total intravenous anesthesia (remimazolam group, n = 45) or sevoflurane-based inhalation anesthesia (sevoflurane group, n = 45). The primary outcome will be the incidence of emergence delirium, which will be evaluated using the Pediatric Anesthesia Emergence Delirium (PAED) scale. The secondary outcomes include the extubation time, recovery time, behavior change using the post-hospitalization behavior questionnaire for ambulatory surgery (PHBQ-AS), and adverse events. Ethics and dissemination: This study has been approved by the Institutional Review Board (IRB) of the Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University (2023-K-262-02). Clinical trial registration: ClinicalTrials.gov, identifier NCT06214117.

SUBMITTER: Ma HY

PROVIDER: S-EPMC11231196 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature

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The effect of remimazolam-based total intravenous anesthesia versus sevoflurane-based inhalation anesthesia on emergence delirium in children undergoing tonsillectomy and adenoidectomy: study protocol for a prospective randomized controlled trial.

Ma Hong-Yu HY Cai Yu-Hang YH Zhong John Wei JW Chen Jia J Wang Zhen Z Lin Chao-Yi CY Wang Qiao-Qiao QQ Liu Hua-Cheng HC

Frontiers in pharmacology 20240625

<b>Background:</b> Remimazolam, a new ultrashort-acting benzodiazepine, is becoming increasingly applied in general anesthesia. This study is designed to investigate the effect of remimazolam-based total intravenous anesthesia and sevoflurane-based inhalation anesthesia on emergence delirium in pediatric tonsillectomy and adenoidectomy. <b>Methods and analysis:</b> This is a monocentric, prospective, randomized, double-blind clinical trial. A total of 90 pediatric patients will be randomized to ...[more]

PMID: 38983921

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Project description:BackgroundPrevious studies have shown that the anesthetic technique may influence long-term outcomes after cancer surgery. However, the association between the anesthetic technique and long-term oncological outcomes after oral cancer surgery remains unclear. Therefore, we conducted this study to address this gap.MethodsWe reviewed the electronic medical records of patients who underwent elective oral cancer surgery between January 2014 and December 2015. The patients were grouped based on the anesthesia maintenance: either propofol or sevoflurane. Propensity score matching in a 1:1 ratio was performed to deal with the potential confounding effects of baseline characteristics. Univariate and multivariate Cox regression analyses were performed to compare hazard ratios (HRs) and identify the risk factors for death and recurrence. Survival analysis was performed using the Kaplan-Meier method, and survival curves were constructed from the date of surgery to death.ResultsIn total, 1347 patients were eligible for analysis, with 343 and 1004 patients in the propofol and sevoflurane groups, respectively. After propensity score matching, 302 patients remained in each group. Kaplan-Meier survival curves demonstrated the 5-year overall and recurrence-free survival rates of 59.3% and 56.0% and 62.7% and 56.5% in the propofol and sevoflurane groups, respectively. There was no significant difference in overall survival or recurrence-free survival between the groups. The multivariate Cox analysis verified this conclusion with HRs of 1.10 and 1.11 for overall survival and recurrence-free survival, respectively, in the sevoflurane group. Older age, advanced tumor-node-metastasis (TNM) stage, and American Society of Anesthesiologists class III were associated with poor overall survival. Patients with advanced TNM stage and poorly differentiated squamous cell carcinoma had a higher recurrence risk than their counterparts.ConclusionThe overall and recurrence-free survival rates were similar between propofol-based intravenous anesthesia and sevoflurane volatile anesthesia in patients who underwent oral cancer surgery.

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:In recent years, more and more attention has been paid to intestinal microbiome. Almost all operations will go through the anesthesia process, but it is not clear whether the intervention of anesthesia alone will affect the change in the intestinal microbiome. The purpose of this study was to verify the effect of sevoflurane inhalation anesthesia on the intestinal microbiome. The animal in the experimental group was used to provide sevoflurane inhalation anesthesia for 4 hours. The control group was not intervened. The feces of the experimental group and the control group were collected on the 1st, 3rd, 7th and 14th days after anesthesia. Sevoflurane inhalation anesthesia will cause changes in the intestinal microbiome of mice. It appears on the 1st day after anesthesia and is most obvious on the 7th day. The specific manifestation is that the abundance of microbiome and the diversity of the microbiome is reduced. At the same time, Untargeted metabonomics showed that compared with the control group, the experimental group had more increased metabolites related to the different microbiome, among which 5-methylthioadenosine was related to the central nervous system. Subsequently, the intestinal microbiome diversity of mice showed a trend of recovery on the 14th day. At the genus level, the fecal samples obtained on the 14th day after anesthesia exhibited significantly increased abundances of Bacteroides, Alloprevotella, and Akkermansia and significantly decreased abundances of Lactobacillus compared with the samples obtained on the 1st day after anesthesia. However, the abundance of differential bacteria did not recover with the changing trend of diversity. Therefore, we believe that sevoflurane inhalation anesthesia is associated with changes in the internal microbiome and metabolites, and this change may be completed through the brain-gut axis, while sevoflurane inhalation anesthesia may change the intestinal microbiome for as long as 14 days or longer.

Project description:Background and aimTotal intravenous anesthesia (TIVA) has proven advantage over inhalational anesthesia in terms of stable hemodynamic, eco-friendly, and good recovery profile, but apprehension regarding adequate depth of anesthesia and intraoperative recall is still pertaining. This study aims to compare propofol-dexmedetomidine-based TIVA with sevoflurane-based inhalational anesthesia in modified radical mastectomy in terms of depth of anesthesia, intraoperative recall, recovery profile, and hemodynamic status.Settings and designThis prospective randomized controlled study was conducted at a tertiary care center over a time frame of 1 year.MethodologyIn this randomized controlled study, 100 patients were randomly distributed into two groups: TIVA (Group T) and inhalational anesthesia (Group I). Group T patients received injection dexmedetomidine: 1 μg.kg-1 over 10 min followed by 0.7 μg.kg-1.h-1 and injection propofol: 25-100 μg.kg-1.min-1. Ventilation was maintained with oxygen-air gas flow. In Group I, patients were ventilated with nitrous oxide-oxygen (50:50) and sevoflurane. Rest of anesthesia for both the groups was same. Primary objective was to achieve adequate depth of anesthesia as monitored by intraoperative bispectral index value (BIS, 40-60). Hemodynamic variables, recovery profile, and amount of individual anesthetic agent consumed were recorded for comparison between two groups. For comparison of scale variables between two groups, independent sample t-test for significant difference between two sample means has been followed.ResultsIntraoperative BIS and hemodynamic variables were comparable (P > 0.05). Emergence time was 5.10 min in the TIVA group versus 8.38 min in the inhalational group (P = 0.00). Modified Aldrete score was comparable in two groups (P > 0.05). Cost of TIVA agents consumed per patient was 40% lesser than inhalational agents.ConclusionTIVA maintains adequate depth of anesthesia along with stable hemodynamic and good recovery profile, at low cost in an eco-friendly manner.

Dataset Information

The effect of remimazolam-based total intravenous anesthesia versus sevoflurane-based inhalation anesthesia on emergence delirium in children undergoing tonsillectomy and adenoidectomy: study protocol for a prospective randomized controlled trial.

Publications

The effect of remimazolam-based total intravenous anesthesia versus sevoflurane-based inhalation anesthesia on emergence delirium in children undergoing tonsillectomy and adenoidectomy: study protocol for a prospective randomized controlled trial.

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