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临床试验/CTRI/2026/02/103667
CTRI/2026/02/103667尚未招募不适用

EFFICACY OF TARGET CONTROLLED INFUSION FOR TOTAL INTRAVENOUS ANAESTHESIA (TCI-TIVA) ON RECOVERY PROFILE IN PATIENTS UNDERGOING MAJOR GASTROENTROLOGY SURGERIES

Dr. Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Gomtinagar, Lucknow, UP1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2026年2月23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
62
试验地点
1

研究概览

简要总结

This study is designed to evaluate the efficacy of target controlled infusion total intravenous anesthesia using Propofol and Remifentanil on the recovery profile and perioperative stability of patients undergoing major gastroenterology surgeries.

Major abdominal surgeries are associated with significant physiological stress and require anesthesia techniques that provide stable hemodynamics, adequate depth of anesthesia, rapid recovery, and minimal postoperative adverse effects. Target controlled infusion systems use pharmacokinetic models to maintain a desired plasma or effect site drug concentration, allowing more precise titration of anesthetic agents compared to conventional manual infusion or inhalational anesthesia.

In this prospective clinical study, adult patients scheduled for elective major gastroenterology procedures under general anesthesia will receive anesthesia maintained with target controlled infusion guided Propofol and Remifentanil infusions according to standard institutional practice. Standard monitoring will be used, and intraoperative parameters such as heart rate, blood pressure, oxygen saturation, end tidal carbon dioxide, and anesthetic drug consumption will be recorded at predefined intervals. The need for additional vasoactive drugs and intraoperative complications will also be documented.

Recovery characteristics will be assessed using objective measures including time to spontaneous breathing, extubation time, response to verbal commands, orientation. Total anesthetic drug consumption will be calculated, and postoperative side effects such as postoperative nausea and vomiting and other adverse events will also be noted. Postoperative outcomes such as pain scores, requirement of rescue analgesia, sedation level, and any respiratory or cardiovascular adverse events will be noted during the immediate postoperative period.

The results of this study will help determine whether target controlled infusion total intravenous anesthesia with Propofol and Remifentanil provides improved recovery quality and perioperative stability in major gastroenterology surgeries, potentially contributing to enhanced recovery protocols and better patient safety.

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

  • Adults aged 18 to 65 years ASA physical status I and II Undergoing elective major gastroabdominal surgery under general anesthesia Provided written informed consent.

排除标准

  • Known allergy to propofol or remifentanil Significant cardiac, hepatic, or renal disease BMI more than 35 Surgery duration more than 8 hr Neurological or psychiatric conditions Pregnant or lactating women.

研究者

发起方
Dr. Ram Manohar Lohia Institute of Medical Sciences, Vibhuti Khand, Gomtinagar, Lucknow, UP
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Shilpi misra

Dr RML IMS, Lucknow

研究点 (1)

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