Comparing Opioid Free Versus Opioid Balanced Anesthesia in Ophthalmic Surgery: a Single Centre Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 104
- 主要终点
- Postoperative nausea and vomiting (PONV)
研究概览
简要总结
Anesthesia without the use of opioid (Opioid free anesthesia) is an alternative to conventional opioid balanced anesthesia, with less post operative nausea and vomiting, and comparable analgesia. This study aim to compare the effect of opioid free versus opioid balanced anesthesia in ophthalmology surgery
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physical status of ASA 1-2
- •Undergo elective ophthalmology surgery under general anesthesia with laryngeal mask insertion
- •BMI 17.5-34.9
排除标准
- •Allergy to study drugs
- •Baseline heart rate < 70 beat per minute or systolic blood pressure < 100 mmHg
- •Will undergo regional block
- •Operation lasting for > 4 hours or < 90 minutes
- •Consumes opioid routinely prior to operation
研究组 & 干预措施
Control
干预措施: Fentanyl (Drug)
Opioid free anesthesia
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Postoperative nausea and vomiting (PONV)
时间窗: 24 hours
Incidence of PONV
Time to laryngeal mask exertion
时间窗: Intraoperative
Measured from the last surgical knot to LMA exertion
Adverse effect
时间窗: 24 hours
Severe changes in hemodynamics, including severe bradycardia, tachycardia, hypotension, hypertension, desaturation
Pain score
时间窗: 24 hours
Pain score assessed with numerical rating scale (0-10) where higher value corresponds to more pain experienced by the patient
次要结局
未报告次要终点
研究者
Aida Rosita Tantri
Anesthesiologist
Indonesia University