跳至主要内容
临床试验/CTRI/2025/04/085338
CTRI/2025/04/085338尚未招募不适用

Comparative Study of Magnesium Sulphate Vs Dexmedetomidine as Adjuvants to Bupivacaine in Scalp Nerve Block: Effects on Intraoperative Hemodynamic Parameters and Postoperative Pain for Patients Undergoing Supratentorial Brain Tumour Craniotomy (A Prospective Randomized Comparative Study)

Mahatma Gandhi Medical College Hospital1 个研究点 分布在 1 个国家目标入组 177 人开始时间: 2025年4月22日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
177
试验地点
1
主要终点
1. To evaluate and compare intraoperative hemodynamic parameters, including heart rate (HR), systolic blood pressure, diastolic blood pressure, and mean arterial pressure.

研究概览

简要总结

This study compares Magnesium Sulphate vs. Dexmedetomidine as adjuvants to Bupivacaine in scalp nerve block for patients undergoing supratentorial brain tumor craniotomy. It evaluates intraoperative hemodynamic stability, postoperative pain relief, and opioid consumption. 177 patients are randomized into three groups receiving Bupivacaine alone, with Dexmedetomidine, or with Magnesium Sulphate. Hemodynamic parameters, pain scores (VAS), cortisol levels, and analgesic requirements are assessed. The goal is to determine which adjuvant optimizes pain control and recovery while reducing opioid use. The study aims to improve anesthesia strategies and postoperative outcomes for brain surgery patients.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
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

  • Patient fulfilling criteria ASA Classes I/ II
  • Patient aged 18-65 years of both sexes.
  • Patients undergoing elective supratentorial craniotomy under general anaesthesia.

排除标准

  • Patient with ASA CLASS III, IV & V Refusal of patient Patient with difficult surgical anatomy Patient with previous craniotomy incision Local infection at the site of injection History of allergy to opioid or local anaesthesia Inability to comprehend or participate in pain scoring system.

结局指标

主要结局

1. To evaluate and compare intraoperative hemodynamic parameters, including heart rate (HR), systolic blood pressure, diastolic blood pressure, and mean arterial pressure.

时间窗: intraoperatively | postoperatively

2. To measure and compare postoperative Visual Analogue Scale (VAS) scores.

时间窗: intraoperatively | postoperatively

3. To determine the time until the first request for rescue analgesia

时间窗: intraoperatively | postoperatively

次要结局

  • • To observe and compare the need for supplemental analgesics during surgery.(• To analyze and compare serum cortisol levels.)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Swati Gupta

Mahatma Gandhi Medical College & Hospital

研究点 (1)

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