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临床试验/CTRI/2025/03/081935
CTRI/2025/03/081935尚未招募Phase 3 4

Comparative study between Segmental spinal block versus General Anesthesia on fitness for patient discharge post operatively in patients undergoing Laparoscopic Cholecystectomy

Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年4月1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
100
试验地点
1
主要终点
Comparison of time to unaided mobility post operatively in patients undergoing laparoscopic cholecystectomy in segmental spinal block versus general anesthesia.

研究概览

简要总结

Written informed consent will be obtained from each lot for anesthesia technique and probabilty to convert to general anesthesia if needed

Group A will undergo Laparoscopic cholecystectomy under general anesthesia and Group B under segmental spinal block

Time to go test will be assessed three hours after completion of surgery i.e whether patients will be able to walk without support for 45 meters and then return to the starting point.Patients will be allowed to leave the hospital once they had passed urine and had been assessed by the surgeon.

Comparison of time to unaided mobility will be assessed every 30minutes post operatively

Incidence of post operative nausea and vomiting in both groups,timing of acceptance of clear fluids & return of bowel movements,post operative pain by visual analogue scale,time at which patient passed urine post operatively,time to discharge will all be assessed thereafter.

研究设计

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

入排标准

年龄范围
30.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • Patients posted for elective laparoscopic cholecystectomy of duration less than 90minutes with uncomplicated gallstone disease of either gender in the age group 30-45,with ASA grade I & II.

排除标准

  • Patient refusal for participating in the study.
  • ASA Grade III and IV patients.
  • Patients with active cholecystitis.
  • Patients with coagulopathy.
  • Patients with BMI more than 32 kg per m
  • Spinal deformity or previous spine surgery.
  • Any other contraindication to central neuraxial blockade or thoracicsegmental spinal anesthesia.
  • Patients allergic to the study drugs.
  • Requiring more than 3 attempts for the procedure.

结局指标

主要结局

Comparison of time to unaided mobility post operatively in patients undergoing laparoscopic cholecystectomy in segmental spinal block versus general anesthesia.

时间窗: assessed every 30minutes post operatively

次要结局

  • Incidence of post operative nausea and vomiting in both groups.(Timing of acceptance of clear fluids & return of bowel movements .)

研究者

发起方
Institute of Medical Sciences
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Saborni Ganguly

Institute of Medical Sciences, Banaras Hindu University

研究点 (1)

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