跳至主要内容
临床试验/CTRI/2025/07/092099
CTRI/2025/07/092099尚未招募不适用

Correlation of the surgical pleth index with the postoperative pain in laparoscopic cholecystectomy an observational study

Prajna Acharya1 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2025年8月11日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
87
试验地点
1
主要终点
To assess correlation of intraoperative SPI values with Postoperative pain scores in patients undergoing elective Laparoscopic Cholecystectomy under General Anaesthesia

研究概览

简要总结

This prospective cross-sectional observational study titled Correlation of the Surgical Pleth Index with Postoperative Pain in Laparoscopic Cholecystectomy aims to examine the relationship between intraoperative Surgical Pleth Index (SPI) values recorded at six specific timepoints during elective laparoscopic cholecystectomy under general anesthesia and postoperative pain intensity. The primary objective is to assess whether intraoperative SPI levels correlate with postoperative pain scores. Secondary objectives include evaluating how demographic factors (age), duration of surgery, comorbidities, and intraoperative analgesic use influence this correlation. There is a notable gap in the literature, as no prior studies have assessed SPI at multiple intraoperative intervals in this surgical context. The findings could inform perioperative pain assessment and individualized analgesic strategies in a routinely performed surgical procedure

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Participants undergoing elective laparoscopic cholecystectomy under General Anaesthesia ASA Physical Status 1 and 2.

排除标准

  • Participants with hypertension and antihypertensive medications especially beta blockers Participants with long standing Diabetes Mellitus Chronic smokers Participants with significant dysrhythmias Participants who receive neuraxial blockade before the surgery Participants with implanted pacemaker.

结局指标

主要结局

To assess correlation of intraoperative SPI values with Postoperative pain scores in patients undergoing elective Laparoscopic Cholecystectomy under General Anaesthesia

时间窗: Preoperative period, Intraoperative period and postoperative period

次要结局

  • Investigate the influence of patient’s demographic factors such as Age, Duration of surgery, comorbidities & intraoperative analgesic intervention on predictive capability of SPI on postoperative pain(On the day of surgery in Preoperative period, Intraoperative period & pain score in postoperative period once patients achieve RASS score of 0 or -1 at 5 minutes 15 minutes, 1 hour & 4 hours)

研究者

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

Prajna Acharya

Manipal College Of Health Professions

研究点 (1)

Loading locations...

相似试验

Understanding how pulse monitor readings relate to... | 临床试验