跳至主要内容
临床试验/CTRI/2023/07/055087
CTRI/2023/07/055087尚未招募Phase 3 4

To evaluate the analgesic efficacy of Ketamine -Dexmedetomidine (Ketodex)in elective laproscopic cholecystectomy - Prospective Randomized double blind control study

Indira Gandhi Institute of Medical Sciences Patna1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2023年7月19日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
102
试验地点
1
主要终点
Visual analogue scale at 0 minute,30 minutes.1hr,2 hr ,4 hr ,6 hr ,8 hr ,12 hr,and 24 hr

研究概览

简要总结

Patients will be  randomly     divided into two Group  based on computer generated random numbers. Before skin incision study drugs will be given by anaesthesiologist who will not participate in study.

Group KD Patients will be received intravenous bolus inj. Ketamine -dexmedetomidine (0.5mg/kg +0.5microgram/kg) in 10 ml over 10 minutes before skin incision.

Group K Patients will be received intravenous bolus ketamine (0.5mg/kg)in 10 ml over 10 minutes before skin incision .

Postoperative pain will be assessed using visual analogue scale at 0 minutes,30 minutes,1hr, 2hr,4hr,6hr,8hr, 12hr and 24 hr.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator 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

  • AS A 1 & 2 Patients having no any co morbidities Patients willing to participate in the trial.

排除标准

  • ASA 3 & 4 Patients having college morbidities Patients not willing to participate in the trial.

结局指标

主要结局

Visual analogue scale at 0 minute,30 minutes.1hr,2 hr ,4 hr ,6 hr ,8 hr ,12 hr,and 24 hr

时间窗: Visual analogue scale at 0 minute,30 minutes.1hr,2 hr ,4 hr ,6 hr ,8 hr ,12 hr,and 24 hr | Time of first rescue analgesia (inj Tramadol ) | Total does of rescue analgesia (Inj.Tramadol)

Time of first rescue analgesia (inj Tramadol )

时间窗: Visual analogue scale at 0 minute,30 minutes.1hr,2 hr ,4 hr ,6 hr ,8 hr ,12 hr,and 24 hr | Time of first rescue analgesia (inj Tramadol ) | Total does of rescue analgesia (Inj.Tramadol)

Total does of rescue analgesia (Inj.Tramadol)

时间窗: Visual analogue scale at 0 minute,30 minutes.1hr,2 hr ,4 hr ,6 hr ,8 hr ,12 hr,and 24 hr | Time of first rescue analgesia (inj Tramadol ) | Total does of rescue analgesia (Inj.Tramadol)

次要结局

  • 1.To assess the side effects of adding ketamine & dexmedetomidine if any (nausea vomiting, & bradycardia).(post-operatively)

研究者

发起方
Indira Gandhi Institute of Medical Sciences Patna
申办方类型
Government medical college

研究点 (1)

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