临床试验/CTRI/2025/07/091948

CTRI/2025/07/091948尚未招募4 期

Evaluation of ketamine as an adjuvant to scalp block for patients undergoing craniotomy

Institute of Neurosciences Kolkata1 个研究点分布在 1 个国家目标入组 62 人开始时间: 2025年8月18日最近更新: 2025年7月27日

试验速览

阶段: 4 期
状态: 尚未招募
发起方: Institute of Neurosciences Kolkata
入组人数: 62
试验地点: 1
主要终点: Reduction in pain assessed by visual analog scale

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

there are limited studies that have attempted to investigate the effect of ketamine in scalp nerve block with local anaesthetic on attenuation of haemodynamic response and postoperative analgesia in patients undergoing craniotomy. Therefore, the present double-blinded randomized clinical trial will be conducted to evaluate the efficacy of ketamine as an adjuvant to scalp nerve block for postoperative analgesia in patients undergoing elective craniotomy for supratentorial space occupying lesion, in a tertiary care hospital of Eastern India.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: Participant and Investigator 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

•Patients posted for elective craniotomoy for supratentorial space occupying lesion, duration of surgery less than 4 hours, body mass index less than 24, ASA grade 1 or 2.

排除标准

•Patient refusal
•ASA grade 3 or 4
•Surgery for cerebral aneurysm or av malformation
•Emergency surgery
•Morbid obesity.

结局指标

主要结局

Reduction in pain assessed by visual analog scale

时间窗: Baseline, 2 hours,4 hours,8 hours,12 hours,24 hours (post operative)

次要结局

Total intraoperative opioid consumption, intraoperative mean arterial pressure & heart rate(Every 30 minutes till closure & at extubation)

研究者

发起方

Institute of Neurosciences Kolkata

申办方类型

Private hospital/clinic

责任方

Principal Investigator

主要研究者

Dr Amrita Roy

Institute of Neurosciences

研究点 (1)

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