EFFECT OF CONTINUOUS INTRAVENOUS LIGNOCAINE INFUSION VERSUS PLACEBO ON INTRAOPERATIVE FENTANYL CONSUMPTION IN PATIENTS UNDERGOING SUPRATENTORIAL TUMOUR RESECTION UNDER GENERAL ANAESTHESIA
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To compare cumulative intraoperative fentanyl consumption in patients undergoing supratentorial tumor resection surgery under general anesthesia, with either intravenous lignocaine infusion or placebo.
研究概览
简要总结
In this double-blind randomized controlled trial, we will enrollapproximately 15 adult
patients in each group scheduled for elective supratentorial tumour surgery.Participants will
be randomly assigned to two groups: one receiving intravenous lignocaineinfusion
(maintenance infusion of 2 mg/kg/hour) and the other receiving a placebo(normal saline
infusion). The primary outcome will measure cumulative intraoperative fentanyl
consumption, while secondary outcomes will assess postoperative opioid-relatedside effects
and postoperative rescue analgesia requirements.
The hypothesis is that intravenous lignocaine infusion will result in lowercumulative
intraoperative fentanyl use, fewer fentanyl-related side effects, andreduced requirements for
analgesia during the perioperative period. The primary objective of thestudy is to compare
cumulative intraoperative fentanyl consumption in patients undergoingsupratentorial tumour
surgery under general anaesthesia with intravenous lignocaine infusionversus placebo. The
secondary objectives are to compare opioid-related side effects and the needfor rescue
analgesia during the postoperative period between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •American Society of Anaesthesiologists (ASA) physical status I and II Body Mass Index = 18.5-35 kg/m2 Glasgow Coma Score 15.
排除标准
- •Refusal to give consent for participation History of allergy to medications to be used in the study Patient routinely taking opioids within last 2 weeks.
结局指标
主要结局
To compare cumulative intraoperative fentanyl consumption in patients undergoing supratentorial tumor resection surgery under general anesthesia, with either intravenous lignocaine infusion or placebo.
时间窗: To compare cumulative intraoperative fentanyl consumption in patients undergoing supratentorial tumor resection surgery under general anesthesia, with either intravenous lignocaine infusion or placebo during skull pin insertion T1, during incision T2, and during any time in the intraoperative period.
次要结局
- 1.To compare the incidence of fentanyl-related side effects, including postoperative nausea, and vomiting (PONV) during the first 24 hours postoperatively between the two study groups.(2.To compare the rescue analgesic requirements during the first 24 hours postoperatively between the two groups, evaluating the effect of intravenous lignocaine infusion on analgesic consumption.)