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临床试验/CTRI/2025/08/092547
CTRI/2025/08/092547尚未招募不适用

Impact of Segmental Spinal Anesthesia on Pulmonary Function and Outcomes in Laparoscopic Cholecystectomy: A Randomized Controlled Pilot Trial

AIIMS Rishikesh1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Peak expiratory flow rate (assessed using a hand-held spirometer)

研究概览

简要总结

This is a prospective, randomised analyser blinded study. This study aims to explore the impact of segmental spinal anaesthesia on postoperative pulmonary function and overall patient outcomes in patients undergoing Laparoscopic cholecystectomy comparing it with general anaesthesia in randomised controlled pilot trials. The study duration is 2 years. Stratified randomization methodology will be used and after allocation patients will be divided into two groups( General anaesthesia and segmental spinal anaesthesia). The primary objective of this study is to compare the peak expiratory flow rate at predefined time points [ preoperative (T0), postoperative (T1) at  6 hr, postoperative day 1(T2), 24 hr postoperative day 2(T3) 48 hr in patients receiving general anaesthesia versus segmental spinal anaesthesia for laparoscopic cholecystectomy surgery. Secondary objectives are to compare other parameters for pulmonaryoutcome analysis at predefined time points , to compare the USG parameters for pulmonary function assessment during perioperative period at predefined time points,  to compare evidence of any other perioperative complication and to compare the satisfaction scores of patients and surgeons in patients undergoing laparoscopic cholecystectomy.

研究设计

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

入排标准

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

入选标准

  • Age 18 to 70 years All genders American Society of Anaesthesiology physical status I till III.

排除标准

  • Patient refusal
  • Contraindications to spinal anaesthesia (e.g., bleeding diathesis, infection)
  • Pregnancy 4.BMI more than 35 5.Severe systemic disease (ASA IV) 6.Patients having pre-existing severe respiratory illnesses (ARISCAT Score more than 44)
  • Vertebral deformity or previous spine surgeries
  • Allergy to local anaesthetics
  • Inadequate spinal anaesthesia effects
  • Intraoperative changes in surgery plan.

结局指标

主要结局

Peak expiratory flow rate (assessed using a hand-held spirometer)

时间窗: T0- preoperative | T1-6 hours post operative period | T2- 24 hours post operative period | T3-48 hours post operative period

次要结局

  • 1. Breath holding time and SpO2(2. Postoperative lung aeration score (USG assessed))

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Nikita Choudhary

AIIMS Rishikesh

研究点 (1)

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