Pregabalin Premedication for Conscious Sedation for Flexible Bronchoscopy: A Randomized Double Blind Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 主要终点
- Total amount of sedative
研究概览
简要总结
Conscious sedation is usually required during flexible bronchoscopy. Sedation should be done without causing respiratory depression or loss of consciousness. The present study was designed to evaluate the advantage of pregabalin pre-medication on reducing sedatives and respiratory depression for patients undergoing flexible bronchoscopy with dexmedetomidine and midazolam.
详细描述
Seventy patients undergoing elective flexible bronchoscopy were randomly divided into two equal groups, 35 patients each. All patients received premedication one hour before the procedure. PG group received 150 mg pregabalin and C group received placebo. All patients sedated to achieve optimum working conditions. Intra-operative respiratory rate and post procedure patients' and pulmonologists' satisfaction were compared in both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 21 and 65 years old American Society of Anaesthesiologists physical status II or III scheduled for elective flexible bronchoscopy
排除标准
- •Patients with known allergy to any drug used in the study, chronic use of analgesics and/or sedatives, substance abuse, sleep apnea, renal or hepatic dysfunction, and psychiatric disorders.
研究组 & 干预措施
Pregabalin (PG)
Patients received 150 mg pregabalin one hour before the procedure.
干预措施: Pregabalin (PG) (Drug)
Control placebo (C)
Patients received placebo tablet one hour before surgery.
干预措施: Control placebo (C) (Drug)
结局指标
主要结局
Total amount of sedative
时间窗: 45 minutes during the procedure
The total amount of the sedative used during the procedure.
次要结局
- Patients' satisfaction(30 minutes after the end of the procedure.)
研究者
Dr Ezzeldin Ibrahim
Assistant Professor in anaesthesia, intensive care, and pain medicine.
Menoufia University