跳至主要内容
临床试验/CTRI/2025/08/092480
CTRI/2025/08/092480尚未招募不适用

Comparative evaluation of pupillometry changes during sevoflurane versus propofol anesthesia in patients undergoing laparoscopic cholecystectomy under general anesthesia

Maulana Azad Medical College and associated Lok Nayak 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20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
Pupillary diameter (PD) in patients undergoing propofol and sevoflurane anesthesia at the time of incision at comparable depths of sedation and nociception.

研究概览

简要总结

We are comparing changes in pupillary diameter with propofol and sevoflurane anesthesia in patients posted for laparoscopic cholecystectomy in Lok Nayak Hospital, Delhi. A total of 70 patients will be enrolled in the study—35 patients in each group. Patients will be explained about the study, and written informed consent will be taken. CONOX monitor electrodes will be attached to patients’ foreheads to record qNOX and qCON values, and a pupillometer will be used to record pupillary diameters. We will be using standard general anesthesia for induction of the patients, and pupillary diameter and qNOX and qCON values will be recorded at certain time intervals during the surgery. Intraoperative analgesic administration will be guided by qNOX.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

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

入选标准

  • Patients having American Society of Anesthesiologists (ASA) physical status I and II.
  • BMI less than or equal to 30 kg/m².

排除标准

  • Pregnant and lactating patients
  • History of allergy to any study drug
  • Patients on antipsychotics medications
  • Neurological disorders and ophthalmic disordersaffecting pupillary size or reaction
  • History of head trauma.

结局指标

主要结局

Pupillary diameter (PD) in patients undergoing propofol and sevoflurane anesthesia at the time of incision at comparable depths of sedation and nociception.

时间窗: TO (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

  • Pupillary diameter at other predefined time intervals
  • Change in pupillary diameters from baseline diameters at various predefined time intervals during the procedure(TO (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

Natasha Yadav

Maulana Azad Medical College and associated hospitals

研究点 (1)

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