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临床试验/CTRI/2024/02/063345
CTRI/2024/02/063345已完成不适用

Opioid free versus Opioid based Anaesthesia for laparoscopic Cholecystectomy- A Randomized clinical trial.

Dr Basavaraj Patil MD1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2024年1月3日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
68
试验地点
1
主要终点
Postoperative pain scores using Visual analogue scale (VAS) between

研究概览

简要总结

A study on Opioid free versus conventional opioid based Laparoscopic cholecystectomy. Aimed at comparing the  pain scores using VAS scores in both the groups along with  intraoperative Hemodynamics like heart rate, blood pressure, MAP. Also to compare the duration of analgesia post operatively, and total analgesics that will be consumed  in first 24 hours post operatively. Any associated adverse effects are also studied. Patients were divided by computer generated  random numbers into 2 groups of 34 patients each who are posted for elective laparoscopic cholecystectomy. Inclusion and exclusion criteria was evaluated and then informed consent was taken. The above study was held at Shri B.M Patil medical college and research centre , vijayapura, karnataka. At the end of the study, it was found that the Opioid free anesthesia group exhibited a significantly longer duration of analgesia compared to conventional opioid group. VAS scores were high in the opioid group especially in the first four hours postoperatively. Consumption of analgesics were less in Opioid free group when compared to conventional opioid group. Intraoperative systolic blood pressure was high in the OFA group, however it was clinically insignificant. Postoperative adverse effects were more prevalent in opioid group.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Patients aged between 18-70 years.
  • Patients of either sex.
  • Patients admitted for laparoscopic cholecystectomy under General Anesthesia with ASA Grade I & II.

排除标准

  • Patients with Obstructive sleep Apnea Syndrome (OSAS),s having significant Cardiopulmonary, hepatic or renal insufficiencies,Allergy to Study medications.

结局指标

主要结局

Postoperative pain scores using Visual analogue scale (VAS) between

时间窗: Postoperative pain scores using Visual analogue scale (VAS) between | opioid free anesthesia and opioid based technique. VAS score was compared at 0, 2, | 4,6,12 and 24 hours.

opioid free anesthesia and opioid based technique. VAS score was compared at 0, 2,

时间窗: Postoperative pain scores using Visual analogue scale (VAS) between | opioid free anesthesia and opioid based technique. VAS score was compared at 0, 2, | 4,6,12 and 24 hours.

4,6,12 and 24 hours.

时间窗: Postoperative pain scores using Visual analogue scale (VAS) between | opioid free anesthesia and opioid based technique. VAS score was compared at 0, 2, | 4,6,12 and 24 hours.

次要结局

  • 1. To compare intraoperative Hemodynamic parameters like Heart rate, Systolic,(Diastolic Blood pressures and Mean Arterial pressures.)

研究者

发起方
Dr Basavaraj Patil MD
申办方类型
Other [guide]

研究点 (1)

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