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临床试验/CTRI/2025/07/091472
CTRI/2025/07/091472已完成4 期

Effects of gallbladder bed irrigation with Ropivacaine vs Normal Saline on Pulmonary functions of patients undergoing laparoscopic cholecystectomy.

Moksha Joshi1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年8月4日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
FEV1, FVC, FEF 25-75

研究概览

简要总结

hypothesis - Gallbladder bed irrigation with ropivacaine, when used as an adjunctive technique during laparoscopic cholecystectomy, will result in improved pulmonary functions compared to standard laparoscopic cholecystectomy without ropivacaine irrigation.

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 65.00 Year(s)(—)
性别
All

入选标准

  • The patients who were willing to participate in study and had given written, valid and informed consent. Age.
  • 18-65 years Patients posted for laparoscopic cholecystectomy American Society of Anaesthesiologist grade I and II Patients belonging to either gender.

排除标准

  • Patient refusal to be part of the study.
  • Patients with known allergies or contraindications to ropivacaine, the agent used for gallbladder bed irrigation.
  • Pregnancy or Lactation: Pregnant or lactating patients, as the safety of ropivacaine use during pregnancy and lactation, is not established.
  • Chronic Respiratory Conditions; Severe Cardiovascular Disease; Severe Liver or kidney disease; acute cholecystitis, choledocholithiasis History of Allergic Reactions; Current Medications; Patients currently taking medications that may interact with ropivacaine (eg Fluvoxamine, cimetidine, ciprofloxacin, ketoconazole, verapamil, amiodarone) or affect pulmonary function particularly medications that influence neuromuscular function (eg aminoglycosides, magnesium, or chronic steroids) or respiratory depression (eg Opioids, benzodiazepines, barbiturates).

结局指标

主要结局

FEV1, FVC, FEF 25-75

时间窗: Baseline, 6 hours, 8 hours, 12 hours, 24 hours

次要结局

  • Visual Analog Scale, BHT, SBC, Cough test

研究者

发起方
Moksha Joshi
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Moksha Joshi

Grant Government Medical College and Sir J.J. Group of hospitals

研究点 (1)

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