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临床试验/CTRI/2025/08/092615
CTRI/2025/08/092615尚未招募不适用

Correlation of Surgical Pleth Index measured at different time intervals with postoperative pain in patients undergoing Laparoscopic Cholecystectomy under General Anaesthesia.

ABVIMS and DR. RML Hospital1 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21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
70
试验地点
1
主要终点
Surgical pleth index measured at 4 time intervals and Post operative pain assessment done in PACU by using NRS.

研究概览

简要总结

This is an Observational study to correlate the surgical pleth index measured at different time intervals with postoperative in patients undergoing laparoscopic cholecystectomy under general anaesthesia, to be conducted in ABVIMS and DR RML Hospital, New Delhi, 110001.

Sample Size=70

The Primary objective is to study the correlation of surgical pleth index measured at 4 time intervals with Postoperative pain in patients undergoing laparoscopic cholecystectomy under General Anaesthesia.

The Secondary objective is to study the correlation between Surgical pleth index and hemodynamic parameters measured at different time intervals with postoperative pain in patients undergoing laparoscopic cholecystectomy under General Ananesthesia.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • ASA I and II patients scheduled for elective laparoscopic cholecystectomy under general anaesthesia.

排除标准

  • Patients on chronic pain medications, History of psychiatric illness or cognitive dysfunction, Conversion to open Cholecystectomy.

结局指标

主要结局

Surgical pleth index measured at 4 time intervals and Post operative pain assessment done in PACU by using NRS.

时间窗: SPI measured at different time intervals 5 minutes before induction, 5 minutes after Veress needle insertion, 5 minutes after Laparoscopic port insertion and 10 minutes before extubation and Post operative pain assessment done in PACU by using NRS at 5, 10, and 15 minutes after recovery.

次要结局

  • Surgical Pleth index and hemodynamic parameters such as Heart Rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Pressure (MAP) measured at 4 time intervals.(5 minutes before induction, 5 minutes after Veress needle insertion, 5 minutes after Laparoscopic port insertion and 10 minutes before extubation.)

研究者

发起方
ABVIMS and DR. RML Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Reshma P

ABVIMS and DR. RML Hospital

研究点 (1)

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