跳至主要内容
临床试验/CTRI/2025/07/090188
CTRI/2025/07/090188招募中3 期

EFFECTIVENESS OF TRAMADOL AND KETAMINE AS ADJUVANTS TO BUPIVACAINE FOR INCISIONAL INFILTRATION FOR POSTOPERATIVE ANALGESIA FOLLOWING MAJOR ABDOMINAL SURGERY UNDER GENERAL ANESTHESIA

Gujarat Cancer and research institute1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
To Compare post operative pain score

研究概览

简要总结

Overnight fasting

All patient will be premedicated with Tab lorazepam (1 mg) at night before surgery.

Preoperative patient will be informed about Numeric Rating Scale for pain.

Local Infiltration at the end of surgery.

ØGroup-1 : Subcutaneous Tramadol 1mg/kg mixed with 0.25% of Bupivacaine 0.7mg/kg (diluted to 20ml with 0.9% NS) (N = 40)

ØGroup-2 : Subcutaneous Ketamine 1mg/kg mixed with 0.25% of Bupivacaine 0.7mg/kg (diluted to 20ml with 0.9% NS) (N = 40)

Standard monitor

Standard General Anaesthesia with proper size cuffed oral endotracheal tube.

Intra-Operative monitoring - HR, ECG, BP, SPO2, ETCO2, Urine output, Temperature

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Open abdomibal surgeries under general anaesthesia.

排除标准

  • Uncotrolled cardio respiratory disorders Altered hepatorenal function Refusal to participate Allergic to study drugs Psychological problems long term opioid users BMI more than 30 kilogram per meter square.

结局指标

主要结局

To Compare post operative pain score

时间窗: 0 hr, 2 hr, 4 hr, 6 hr, 12 hr, 18 hr, 24 hrs after Infiltration

次要结局

  • To compare duration of analgesia(To compare post-operative rescue analgesic requirements)

研究者

发起方
Gujarat Cancer and research institute
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Darotikumari Sudhirbhai Patel

Gujarat cancer and Research institute,BJMC

研究点 (1)

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