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临床试验/CTRI/2023/08/056241
CTRI/2023/08/056241尚未招募4 期

Efficacy and safety during Endoscopic Retrograde Cholangio-Pancreatography under Total Intravenous Anesthesia-Propofol alone versus Propofol supplemented with Dexketa, a comparative study in Medical College Kolkata

Dr Debasish Ghosh1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2023年8月16日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
66
试验地点
1
主要终点
A decrease in heart rate when Dexmedetomidine is used

研究概览

简要总结

Endoscopic Retrograde Cholangio Pancreatography (ERCP) is an invasive procedure and hence is distressing for awake patients, requiring adequate level of anaesthesia. Recent advancements have encouraged use of monitored anaesthesia care (MAC) , that allows the patient to tolerate unpleasant procedures while maintaining cardio-respiratory function. The main aim was to compare the effect of Propofol alone and Propofol with Ketamine and Dexmedetomidine on the hemodynamics during ERCP, recovery profile and side effects (if any).

This is a comparative study. Adult patients from age group of 18-70 years belonging to ASA-I and ASA-II who will undergo ERCP under TIVA (Total Intravenous Anaesthesia) will be taken and will randomly be assigned to either of the two groups. Both groups will receive 0.2mg Glycopyrrolate, 4mg Ondansetron, 1mg Midazolam, 50mcg Fentanyl and 40mg Hyoscine. Group A patients will receive 30mg Propofol as bolus dose and will be repeated according to requirements. Group B patients will receive 0.5mcg/kg Dexmedetomidine as loading dose and 0.3mcg/kg as infusion dose. 20mg Propofol will be given before negotiating scope and then 1ml (1:1) mixture of Propofol and Ketamine will be repeated every 10 minutes. Total Propofol consumption, hemodynamics, quality of recovery and side effects (if any) will be recorded at regular intervals.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Physical status ASA-PS 1 and ASA-PS 2 Having no anticipated difficult airway.

排除标准

  • Patient refusal AKI,CKD,Low Ejection Fraction, Uncontrolled Diabetes Undergoing emergency procedure Known allergy to drugs to be used in the study Previous bleeding disorder or coagulopathy Administration of any sedative or narcotics within 24 hours Duration more than 60 minutes.

结局指标

主要结局

A decrease in heart rate when Dexmedetomidine is used

时间窗: Baseline, 4 weeks, 8 weeks

次要结局

  • Dose of Propofol required will be much less when used along with Ketamine & Dexmedetomidine(BASELINE 4 WEEKS AND 8 WEEKS)

研究者

发起方
Dr Debasish Ghosh
申办方类型
Other [self]

研究点 (1)

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