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临床试验/CTRI/2026/02/104261
CTRI/2026/02/104261尚未招募不适用

Intraoperative nociceptive responses and postoperative complications in patients undergoing laparoscopic colorectal surgery under general anaesthesia - A prospective observational study

Regional Cancer Centre Thiruvananthapuram1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2026年2月28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
82
试验地点
1
主要终点
Correlation between mean nociceptive response index and post operative complications

研究概览

简要总结

Nociception is the neural process of encoding and processing noxious stimuli. In conscious state, noxious stimuli cause the sensation of pain as response. Response to noxious stimuli during unconsciousness i.e., during general anaesthesia, however, are different from those in the awake state.Surgical invasion which activates peripheral nociceptors, induces autonomic responses, including increase in blood pressure and heart rate, and decrease in peripheral blood flow, under general anaesthesia.Intraoperative surgical stimulation also increases inflammation and tissue damage during surgery by producing various cytokines and chemokines.C - Reactive protein is a biomarker for such inflammatory process.The nociception produced by surgical invasiveness should be effectively balanced by anaesthesia.Monitoring nociception is an important growing area of investigation. Nociceptive response index (NRI), a recently proposed index is a dimensionless number between 0 & 1. It was developed based on appropriate mathematical models representing autonomic activation responses to noxious stimulation and considering heart rate, systolic blood pressure and perfusion index in calculating the numerical value. Hirose et al., evaluated its utility to discriminate nociceptive responses to a small and large skin incision in laparotomy and found that NRI quantitatively discerned the differences. They suggested that NRI could be used to assess either real time nociceptive responses or averaged nociceptive responses throughout surgery without special equipment.

A higher level of surgical stimulus is associated with more physiological responses which in turn is thought to be associated with incidence of postoperative morbidity and mortality.This study is based on the hypothesis that intraoperative nociceptive responses can add on to postoperative complications in patients undergoing colorectal surgery under general anaesthesia.

Postoperative complications can be classified as per modified Clavien – Dindo classification system.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • ASA class 1 & 2 Patients undergoing elective colorectal surgeries.

排除标准

  • BMI more than kg/m^2 Patients who will require intraoperative vasopressor will be excluded from the study.

结局指标

主要结局

Correlation between mean nociceptive response index and post operative complications

时间窗: 30 days

次要结局

  • Intraoperative nociceptive responses using nociceptive response index
  • To study the amount of opioids required for proper control of intraoperative nociception(At baseline)
  • To study the perioperative variables amounting to postoperative complications.(30 days)

研究者

发起方
Regional Cancer Centre Thiruvananthapuram
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr Subha R

Regional cancer centre, Thiruvananthapuram

研究点 (1)

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