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临床试验/CTRI/2024/05/067636
CTRI/2024/05/067636尚未招募不适用

Correlation of Pupillary diameter with Quantium Nociception Index for estimation of intraoperative pain in patients undergoing laparoscopic cholecystectomy under general anaesthesia

Maulana Azad Medical college and associated Lok Nayak Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年6月1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
40
试验地点
1
主要终点
Establish the correlation between pupillary diameter and quantium nociception index (qNOX) values for estimation of intraoperative pain during general anaesthesia in laparoscopic cholecystectomy

研究概览

简要总结

We are correlating change in pupillary diameter with quantium nociception index (qNOX) for estimation of intraoperative pain in patients posted for laparoscopic cholecystectomy in Lok Nayak Hospital, Delhi. A total of 40 patients will be enrolled for the study. Patients will be explained about the study and written informed consent will be taken. CONOX monitor electrodes will be attached to patients’ forehead to record qNOX values and pupillometer will be used to record pupillary diameters. We will be using standard general anaesthesia for induction of the patients and pupillary diameter and qNOX values will be recorded at certain time intervals during the surgery. Intraoperative analgesic administration will be guided by qNOX. At the end, numerical rating scale will be used to assess pain postoperatively.

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

  • 18 to 60 years of age of either sex
  • American Society of Anaesthesiologists Physical Status I and II
  • Body Mass Index less than/ equal to 30Kg/m2.

排除标准

  • 1.Pregnancy and lactation 2.Psychiatric illness and patient suffering from intellectual disability 3.History of comorbidities such as Hypertension or any cardiac disease 4.History of allergy to any drug as per protocol 5.History of use of psychoactive drugs 6.Any neurological disorders 7.Eye disorders affecting pupillary size or reaction.

结局指标

主要结局

Establish the correlation between pupillary diameter and quantium nociception index (qNOX) values for estimation of intraoperative pain during general anaesthesia in laparoscopic cholecystectomy

时间窗: T0(Baseline) – before induction | T1 - 1 min after induction | T2 - At skin incision | T3 - During trochar insertion | - every 15 min interval following T3 | -At the end of surgery

次要结局

  • Correlation between pupillary diameter and hemodynamic parameters (HR, SBP, DBP, MAP) at different time intervals.(T0(Baseline) – before induction)

研究者

发起方
Maulana Azad Medical college and associated Lok Nayak Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Himanshu Garg

Maulana Azad Medical College and associated Lok Nayak Hospital

研究点 (1)

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