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临床试验/NCT07189845
NCT07189845已完成不适用

Effect of Bispectral Index (BIS)-Guided Anesthesia on Postoperative Nausea and Vomiting in Children Aged 3 to 8 Years: A Prospective Randomized Controlled Trial

Engin Çetin1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2025年9月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
58
试验地点
1
主要终点
Incidence of postoperative nausea and vomiting (PONV) during the first 24 hours postoperatively.

研究概览

简要总结

This randomized controlled trial will evaluate the effect of bispectral index (BIS)-guided anesthesia on postoperative nausea and vomiting (PONV) in children aged 3-8 years undergoing elective adenoidectomy. Fifty-eight patients will be randomized to BIS-guided anesthesia (target 40-60) or standard clinical management. The primary outcome is PONV incidence within 24 hours. Secondary outcomes include antiemetic use, emergence time, hospital stay, and parental satisfaction.

详细描述

This prospective, randomized, double-blind controlled trial aims to evaluate the effect of bispectral index (BIS)-guided anesthesia on postoperative nausea and vomiting (PONV) in children aged 3 to 8 years undergoing elective adenoidectomy. PONV is a common postoperative complication in pediatric surgery, with reported incidences of 30-70%, leading to delayed oral intake, prolonged hospital stay, and reduced parental satisfaction. BIS monitoring provides an objective EEG-based measure of anesthesia depth, allowing precise titration of anesthetic agents and potentially reducing postoperative complications. While adult studies and meta-analyses have shown that BIS guidance decreases the incidence of PONV, evidence in pediatric populations remains limited. A total of 58 ASA I-II patients will be randomized into two groups: BIS-guided anesthesia (target 40-60) and standard clinical parameter-guided anesthesia with the BIS screen hidden. The primary outcome is the incidence of PONV within 24 hours postoperatively. Secondary outcomes include antiemetic use, severity of PONV, time to emergence, length of hospital stay, and parental satisfaction assessed with a Likert scale. The findings of this trial are expected to clarify the role of BIS monitoring in improving postoperative outcomes in pediatric anesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double (Participant, Investigator)

盲法说明

Parallel Assignment

入排标准

年龄范围
3 Years 至 8 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Children aged 3-8 years
  • •ASA physical status class I-II
  • •Scheduled for elective adenoidectomy
  • •Written informed consent obtained from parents

排除标准

  • •Children with a previous history of PONV
  • •Patients receiving antiemetic, steroid, or sedative medication
  • •Acute upper respiratory tract infection
  • •History of neurological or psychiatric disorders
  • •Body mass index (BMI) below the 5th percentile or above the 95th percentile
  • •Anatomical airway abnormalities

研究组 & 干预措施

BIS GROUP

Active Comparator

BIS monitoring will be visible, and anesthesia depth will be adjusted according to BIS values (40-60).

干预措施: BIS GROUP (Diagnostic Test)

CONTROL GROUP

Active Comparator

In the control group, the BIS monitor will be applied with the screen concealed from the investigator, and anesthesia depth will be guided solely by clinical parameters

干预措施: CONTROL GROUP (Diagnostic Test)

结局指标

主要结局

Incidence of postoperative nausea and vomiting (PONV) during the first 24 hours postoperatively.

时间窗: T1: Immediately before extubation T2: 6 hours after extubation T3: 12 hours after extubation T4: 24 hours after extubation

PONV will be assessed at postoperative intervals of 0-6, 6-12, and 12-24 hours. The Postoperative nausea and vomiting (PONV) will be assessed at postoperative intervals of 0-6, 6-12, and 12-24 hours. PONV severity will be evaluated using a predefined four-point ordinal scale based on the presence and frequency of nausea and vomiting, as follows: 0: No nausea or vomiting 1. Mild nausea 2. Severe nausea or a single vomiting episode 3. Severe nausea with multiple vomiting episodes or intractable PONV

次要结局

  • Emergence Time(From discontinuation of sevoflurane at the end of surgery until eye opening in response to verbal command, assessed up to 30 minutes)
  • Antiemetic use and timing(0-24 hours postoperatively)

研究者

发起方
Engin Çetin
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Engin Çetin

principal investigator

Kocaeli City Hospital

研究点 (1)

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