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临床试验/CTRI/2026/03/105681
CTRI/2026/03/105681尚未招募3 期

A Randomized Controlled Trial Comparing Opioid Free Protocol Using Combination of intravenous Ketamine Dexamethasone and Conventional opioid-based Regime for Laproscopic Tubal Ligation

Dr Baba Saheb Ambedkar Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年3月23日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
100
试验地点
1

研究概览

简要总结

Laparoscopic tubal ligation is commonly performed under procedural sedation and analgesia using opioid-based regimens. Opioids, although effective, are associated with adverse effects such as respiratory depression, postoperative nausea and vomiting, delayed recovery, and risk of persistent opioid use. Opioid-free anaesthesia (OFA) has emerged as an alternative strategy to reduce opioid-related complications.

This randomized, double-blind controlled trial aims to compare the efficacy and safety of an opioid-free protocol using intravenous ketamine and dexamethasone in combination with propofol versus a conventional opioid-based regimen using fentanyl and propofol in women undergoing laparoscopic tubal ligation.

A total of 100 ASA I–II female patients aged 18–45 years will be randomized into two equal groups. The primary outcomes include postoperative analgesic requirement, intraoperative haemodynamic stability, and additional propofol requirement. Secondary outcomes include postoperative pain scores, postoperative nausea and vomiting, duration of PACU stay, patient satisfaction, failure of opioid-free anaesthesia, and adverse events.

The study aims to evaluate whether the ketamine–dexamethasone combination provides effective analgesia with fewer opioid-related side effects and improved recovery characteristics.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • merican Society of Anesthesiologists (ASA) Physical Status I or II.
  • Scheduled for elective laparoscopic tubal ligation under procedural sedation and analgesia.
  • Willing to participate and provide written informed consent.

排除标准

  • Body Mass Index (BMI) more than 30 kg/meter square.
  • Known allergy or hypersensitivity to propofol, ketamine, dexamethasone, fentanyl, or any study drug.
  • History of diabetes mellitus.
  • Presence of acute or chronic infection.
  • History of chronic opioid use.
  • History of substance abuse.
  • History of psychiatric illness.
  • History of gastroesophageal reflux disease (acid reflux).

研究者

发起方
Dr Baba Saheb Ambedkar Medical College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Dipakshi Phooli

Dr Baba saheb ambedkar hospital and medical college

研究点 (1)

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