Nalbuphine/Dexmedetomidine Versus Nalbuphine/Propofol Conscious Sedation for Cataract Extraction Under Topical Anaesthesia: A Double-Blind Randomized Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Sedation score
研究概览
简要总结
Topical anaesthesia of the eye for ophthalmologic procedures avoids pain and discomfort of local anaesthetic injection in the peribulbar or retrobulbar block so that patient comfortability is achieved. Sedation during topical anaesthesia of the eye is mostly required to achieve anxiolysis, amnesia and keeping the patient calm all through the procedure. In the present study, the investigators will investigate the effect of nalbuphine/dexmedetomidine versus nalbuphine/propofol on the sedation as a primary outcome, intra-operative, postoperative analgesia, vital signs, patient and surgeon satisfaction and side effects as secondary outcomes
详细描述
In both groups, the patients will receive i.v. nalbuphine 50 μg/kg. Patients in group D, will receive an i.v. loading dose of dexmedetomidine 1 μg/kg over 10 min followed by a maintenance infusion of 0.5 μg/kg/h. Patients in group P, will receive a bolus i.v. dose of propofol 0.5 mg/kg followed by an infusion started at 0.025 mg/kg/min .If sedation score was <3, rescue sedation with boluses of midazolam 0.01 mg/kg will be given. If the patient complained of pain (Numerical verbal pain rating scale ≥3) during the surgery, i.v. fentanyl 50 μg will be given as an intra-operative rescue analgesic and the surgeon will be instructed to use additional topical local anaesthetic eye drops if appropriate. After the completion of surgery, all infusions will be stopped, and the patients will be shifted to the postanaesthetic care unit (PACU) to be monitored for 2 hours before discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
An independent anaesthesiologist not involved in the study will open the randomisation envelope just before the premedication and will prepare the appropriate drug-filled syringes according to the code and will not take part in the management and observations. (Syringes and infusion lines will be concealed by wrapping with an aluminium foil). A blinded investigator that will not be involved in the anaesthetic management of the patients, will collect the intra-operative and postoperative data.
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both genders,
- •20 and 65 years,
- •American Society of Anesthesiologists (ASA) physical status I and II,
- •Scheduled for cataract extraction surgery under topical anaesthesia.
排除标准
- •Known allergy to local anaesthetics,
- •Allergy to study drugs,
- •Second or third-degree heart block,
- •Alcohol or drug abuse
- •Morbid obesity, pregnant and lactating females,
- •Patients with severe cardiac, renal and hepatic disorders.
研究组 & 干预措施
Group P
nalbuphine/propofol group
干预措施: Nalbuphine (Drug)
Group P
nalbuphine/propofol group
干预措施: Propofol (Drug)
Group P
nalbuphine/propofol group
干预措施: Benoxinate Hydrochloride 0.4% Eye Drops (Drug)
Droup D
Nalbuphine/dexmedetomidine group
干预措施: Nalbuphine (Drug)
Droup D
Nalbuphine/dexmedetomidine group
干预措施: Dexmedetomidine (Drug)
Droup D
Nalbuphine/dexmedetomidine group
干预措施: Benoxinate Hydrochloride 0.4% Eye Drops (Drug)
结局指标
主要结局
Sedation score
时间窗: perioperative
The degree of sedation assessed by Ramsay sedation score(1 = anxious, agitated, restless;2 = cooperative, oriented, tranquil; 3 = responds to commands only; 4 = brisk response to light glabellar tap or loud noise; 5 = sluggish response to light glabellar tap or loud noise; 6 = no response), score of (1) means inadequate sedation. Score (2 to 4) indicates acceptable sedation. Score (5) or (6) excessive sedation.
次要结局
- Heart rate(perioperative)
- Oxygen saturation(perioperative)
- Analgesia(perioperative)
- Mean arterial blood pressure(perioperative)
研究者
Abd-Elazeem Abd-Elhameed Elbakry
Associate professor of anaesthesia
Menoufia University