Opioid Free Versus Opioid Balanced Anesthesia in Middle Ear Surgery.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- PONV
研究概览
简要总结
OPIOID FREE VERSUS OPIOID BALANCED ANAESTHESIA IN MIDDLE EAR SURGERY AIM OF THE WORK
Primary aim:
To compare between opioid and opioid free anaesthesia on post-operative nausea and vomiting in middle ear surgery
Secondary aim:
Monitoring analgesia, post-operative satisfaction and drowsiness.
详细描述
After approval of the Ethical Committee of Faculty of Medicine, Alexandria University and having an informed written consent from every patient included in the study, the present study will be carried out in Alexandria Main University Hospitals on sixty adult patients belonging to ASA class I or II scheduled for middle ear surgery under general anaesthesia.
(The sample size is approved to be sufficient by the Department of Statistics, Medical Research Institute, University of Alexandria).
Inclusion criteria:
- Patients of either sex.
- American Society Anesthesiologists' physical status I-II.
- Age between 18 and 50 years. Exclusion criteria:(depend on table 1)
- Patients with gastrointestinal disease.
- A history of motion sickness, or a previous episode of PONV.
- Patient received any opioid, steroid, or antiemetic medication within 72 h before surgery.
- Those who were pregnant or menstruating.
- History of opioid or drug abuse. METHODS Patients will be randomly allocated into two equal groups (thirty patients each) using the closed envelope method.
I will compare postoperative nausea and vomiting (PONV) in patients scheduled for middle ear surgery. Sixty patients will be randomly allocated to receive either balanced anaesthesia (group A) using fentanyl, propofol and isoflurane, or opioid free anaesthesia (group B) using propofol and isoflurane. Pain scores, nausea ⁄ vomiting scores, conditions for surgery and analgesic requirements will be recorded post operatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Doctors, patients and outcomes assessors will be blinded regarding the technique used in anesthesia.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of either sex.
- •American Society Anesthesiologists' physical status I-II.
- •Age between 18 and 50 years.
排除标准
- •Patients with gastrointestinal disease.
- •A history of motion sickness, or a previous episode of PONV.
- •Patient received any opioid, steroid, or antiemetic medication within 72 h before surgery.
- •Those who were pregnant or menstruating.
- •History of opioid or drug abuse.
研究组 & 干预措施
Fentanyl Opioid Anesthesia
Fentanyl (1mg/kg i.v.) will be administered before general anaesthesia (GA). GA will be maintained with inhalation anaesthetics (isoflurane) at a minimum alveolar concentration of 0.7-1.3.
干预措施: Fentanyl Opioid anesthesia (Drug)
Saline Nonopioid Anesthesia
Opioid free anesthesia (syringe of saline is given instead of fentanyl) and the same general anesthesia is given as group A(muscle relaxant ,propofol, inhalation for maintance).
干预措施: Saline Nonopioid anesthesia (Drug)
结局指标
主要结局
PONV
时间窗: 72 hours
Post operative nausea and vomiting from 0-3 for nausea and 0 to 4 for vomiting
次要结局
- Drowsiness(72 hours)
- analgesia.post-operative pain(72 hours)
- Patient satisfaction(72 hours)
研究者
Mohammad Hazem I. Ahmad Sabry
Lecturer of Anesthesia
University of Alexandria