Dexmedetomidine With or Without Pregabalin Premedication for Conscious Sedation During Cataract Surgery Under Topical Anesthesia. A Randomized Double-blind Placebo-controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- sedation score changes
研究概览
简要总结
Although topical anesthesia by eye drops for cataract surgery is a non-invasive technique but it may provide insufficient anesthesia which requires the intraoperative use of additional topical local anesthetics and raises the need for sedation.
详细描述
The present study is constructed to evaluate the effect of pregabalin on sedation using dexmedetomidine for cataract surgery under topical anesthesia . In the dexmedetomidine-pregabalin group, the patients will be premedicated by pregabalin. In the placebo group (control group) the patients will be premedicated by placebo capsules. All patients will be sedated by dexmedetomidine. Sedation will be assessed as a primary outcome measurement where pain, vital signs, intraoperative and postoperative pain, total analgesic needs and side effects will be assessed as secondary outcome measurements.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The patients, the surgeons and the research team will be blinded to the randomization.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society Of Anesthesiologists (ASA) I and II physical status.
- •Scheduled for cataract extraction under topical anesthesia.
排除标准
- •Hepatic or renal impairment.
- •Taking chronic psychotropic medications.
- •Mental instability.
- •Morbid obesity.
- •Alcohol abuse.
- •Substance abuse.
- •Pregnant and lactating females.
- •History of allergy to the study drugs used
研究组 & 干预措施
Control
placebo oral capsule+ dexmedetomidine+topical anesthesia
干预措施: Dexmedetomidine Injection (Drug)
Control
placebo oral capsule+ dexmedetomidine+topical anesthesia
干预措施: Placebo oral capsule (Drug)
Control
placebo oral capsule+ dexmedetomidine+topical anesthesia
干预措施: topical anesthesia (Drug)
Dexmedetomidine- Pregabalin
Pregabalin Oral Capsule +Dexmedetomidine Injection+topical anesthesia
干预措施: Dexmedetomidine Injection (Drug)
Dexmedetomidine- Pregabalin
Pregabalin Oral Capsule +Dexmedetomidine Injection+topical anesthesia
干预措施: Pregabalin Oral Capsule (Drug)
Dexmedetomidine- Pregabalin
Pregabalin Oral Capsule +Dexmedetomidine Injection+topical anesthesia
干预措施: topical anesthesia (Drug)
结局指标
主要结局
sedation score changes
时间窗: baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours
Ramsay sedation score from 1 to 6. score 2 to 4 is acceptable sedation. Score 5 or 6 is excessive sedation.
次要结局
- pain score changes(baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours)
- heart rate changes(baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours)
- arterial oxygen saturation(baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours)
- Incidence of ataxia(from administering premedication till 24hours postoperative)
- arterial blood pressure changes(baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours)
- Incidence of hypotension(from administering premedication till 24hours postoperative)
- respiratory rate(baseline,1hour after premedication, intraoperative every 5 minutes ,postoperative every 6hours for 24 hours)
- total dexmedetomidine consumption(intraoperatively)
- Incidence of respiratory depression(from administering premedication till 24 hours postoperative.)
- Incidence of bradycardia(from administering premedication till 24hours postoperative)
研究者
Abd-Elazeem Abd-Elhameed Elbakry
assistant professor
Menoufia University