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临床试验/NCT07114237
NCT07114237尚未招募不适用

The Effect of Opioid Free Anesthesia in Morbid Obese Patient Undergoing Gynecological Surgeries Using Ultrasound-Guided Bilateral Transversus Abdominus Plane Block and Dexmedetomidine Infusion: A Randomized Controlled

Tanta University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年8月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
150
试验地点
1
主要终点
quality of recovery on postoperative day

研究概览

简要总结

This study aimed to determine the effects of Opioid-free anesthesia using dexmedetomidine and bilateral Transversus abdominis plane block on the quality of recovery, incidence of Opioid-free anesthesia, and post-operative pain and delirium in morbid obese patients undergoing gynecological surgeries.

详细描述

Opioid analgesic drugs have been the most commonly used perioperative pain-relieving medications for a very long time. While they are effective at relieving somatic pain they, unfortunately, do not eliminate neuropathic pain and have a profound potential for developing addiction.

The most significant opioid side effect is respiratory depression. This is especially important in patients with obesity, sleep apnea, chronic obstructive pulmonary disease and operations that are associated with a high incidence of post-operative respiratory failure.

Opioid may also induce post-operative nausea and vomiting , pruritus, urine retention, postoperative delirium. Furthermore, opioids depress cell mediated immunity and, in some studies, opioids have been found to be associated with an increased tumor recurrence rate after cancer surgery.

Opioid-free anesthesia has become more and more popular among anesthesiologists around the world. It is an emerging technique and a recent research perspective based on the idea that avoiding intraoperative opioids would be associated with better postoperative outcomes. It allows opioid-sparing and better outcomes than morphine administered as a sole analgesic agent after surgery. Opioid-free anesthesia is based on the same concept, as one drug will not replace opioids. It is the association of drugs and/or techniques that allows a good quality general anesthesia with no need for opioids. Dexmedetomidine is an alpha-2 agonist with analgesic action. Unlike opioids it is not associated with significant respiratory depression, post-operative nausea and vomiting, pruritus, constipation, ileus or delirium.

In laparoscopic surgeries, it has been found to provide adequate analgesia when used as the only analgesic. It provides enhanced recovery and patient satisfaction after laparotomy and should be considered as part of any enhanced recovery after surgery program.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
21 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 50 female patients aged 21-65 years.
  • Patients with a Body mass index≥ 35 kg/m2
  • American society of Anesthesiology class II-III.
  • Undergoing elective gynecological surgeries.

排除标准

  • Patient refusal.
  • History of allergy to local anesthetic.
  • Liver or renal pathology affecting drug elimination.
  • Mental dysfunction or cognitive disorders.
  • Patients on chronic pain medications.
  • Hypotension, bradycardia, atrioventricular block, intraventricular or sinoatrial block.
  • Coagulopathy

结局指标

主要结局

quality of recovery on postoperative day

时间窗: one day

The Quality of Recovery-40 questionnaire scores. The Quality of Recovery-40 questionnaire includes five dimensions of recovery: physical comfort (12 items), emotional state (9 items), physical independence (5 items), psychological support (7 items), and pain (7 items).

次要结局

  • Postoperative pain severity(24 HOURS)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Merihan Alaa Eldin Ahmed

Resident

Tanta University

研究点 (1)

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