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临床试验/CTRI/2024/01/061321
CTRI/2024/01/061321已完成不适用

Opioid free technique enhances safety in patients with morbid obesity and obstructive sleep apnea, undergoing non -bariatric surgery : a double blind randomised controlled study

Max Healthcare1 个研究点 分布在 1 个国家目标入组 139 人开始时间: 2024年1月15日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
139
试验地点
1
主要终点
Discharge readiness : DR in hours

研究概览

简要总结

Opioids have been known to potentiate airway related adverse events related to sleep-disordered breathing in all patients, moreso, in the patients with morbid obesity. There is progressively large number of surgical patients with obesity and obstructive sleep apnea requiring not just bariatric but also non-bariatric surgery.

There are increasing reports of post operative adverse events in them.particularly  high risk of airway related adverse events (ARAE: risk of obstructed breathing, increased sedation and hypersomnolence) in the postoperative period. Furthermore, opioids are likely to put hurdle by increasing nausea, vomiting, respiratory depression, delayed emergence with hypoventilation , muscle fatigue , ileus and urinary retention to name a few. [4].

This remains a major deterrent while considering them for general anesthesia or ambulatory surgery. Though laparoscopic surgeries under ERAS (enhanced recovery after surgery) represents the best possible patient safety and quality improvement program, there remains a caveat with respect to use of opioids.

Anaesthetic considerations in ERAS have been well established including the multimodal analgesic approach, there remains speculation that opioid-free anaesthesia may offer additional benefit to achieve the goals of ERAS moreso, for this vulnerable group of patients. This remains main reason for considering use of opioid-free anesthesia techniques in them..

The concept of OFA (opioid free analgesia) techniques in the era of evidence- based medicine has emerged as a feasible safe option.  There is paucity of well structured studies to support the concept of OFA in this population.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Eligible patients will include consented adult patients of either gender, between the age of 18 and 65; body mass index (BMI) between 40 and 60; planned for elective laparoscopic cholecystectomy under general anesthesia.

排除标准

  • Patients with preoperative chronic use of opioid or NSAID; allergy to bupivacaine; local skin infection at the injection site of USTAP (ultrasound guided subcostal transverse abdominis plane block); liver or renal insufficiency; psychiatric, or neurological disease; prior open abdominal surgery above T10 dermatome; patients converted to open surgery; and patients expected to be subjected to more tissue trauma will be excluded from the study.

结局指标

主要结局

Discharge readiness : DR in hours

时间窗: Discharge readiness : DR in hours

次要结局

  • Assessment of OFA on discharge readiness, quality of recovery, opioid consumption and patient satisfaction(At the time of discharge readiness)

研究者

发起方
Max Healthcare
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Aparna Sinha

Max Healthcare

研究点 (1)

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