Comparison of Recovery Profiles of Propofol, Dexmedetomidine, and Remimazolam for Monitored Anesthetic Care in Patients Undergoing Upper Limb Surgery Under Brachial Plexus Block : a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Recovery profile
研究概览
简要总结
A total of 120 patients (American Society of Anesthesiologist Physical Status 1-3) who signed a consent form among patients aged 19-80 years who are scheduled to undergo brachial plexus block and upper extremity surgery under monitored anesthetic care at our hospital were enrolled.
Recruited patients are divided into three groups through computer-generated randomization by using the patient identification number assigned during patient recruitment. (40 people in each group) Standard monitoring is performed when the patient arrives at the operating room. Patients receive oxygen at 5-6 L/min using a simple facial mask, and receive a brachial plexus block under ultrasound guidance. After confirming the success of brachial plexus block, administration of propofol, remimazolam, or dexmedetomidine is started according to the assigned group. Assess the patient's level of consciousness through the MOAA/S (modified observer's assessment of alertness/sedation scale) scale. The drug injection ends when the skin suture is started after the main procedure. The time from the end of injection of each drug until MOAA/S becomes 5 points is measured. After the patient is transferred to the recovery room, the Aldrete score is assessed.
The recovery profile, perioperative hemodynamic change, desaturation event, block duration, patient movement during surgery, patient satisfaction, and surgeon's satisfaction were investigated and analyzed for comparison.
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
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA PS 1-3
- •Patients scheduled for upper extremity surgery under brachial plexus block and monitored anesthetic care
排除标准
- •Patients who refuse to participate in this study
- •Patients with poorly controlled hypertension, hyperthyroidism, or moderate to severe heart disease
- •Patients with severe hepatic or renal disease
- •Patients who are chronically using antidepressants, anticonvulsants, or psychoactive drugs
- •Patients who abuse drugs or alcohol
- •Patients with severe sleep apnea
- •Patients with cognitive impairment who have severe difficulties in communication
- •Patients with allergy to propofol, dexmedetomidine, or remimazolam
- •Patients judged to be inappropriate for this study
研究组 & 干预措施
Remimazolam
Maintenance doses of remimazolam is administered for sedation
干预措施: Remimazolam (Drug)
Propofol
Propofol is administered for sedation through target-controlled infusion
干预措施: Propofol (Drug)
Dexmedetomidine
Loading and maintenance doses of dexmedetomidine are administered for sedation
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Recovery profile
时间窗: up to 1 hour after post-anesthesia case unit entry
Time taken for MOAA/S score to reach 5 (MOAA/S: Modified Observer's Alertness/Sedation scale) Awake (5) - Unresponsive (0)
次要结局
- Surgeon's satisfaction(From end of surgery until 24 hours after end of surgery)
- Length of stay in post-anesthesia care unit(up to 3 hours after post-anesthesia case unit entry)
- Occurrence of desaturation during surgery(From the start of sedative injection to the end of surgery or assessed up to 3 hours)
- patient satisfaction(From end of surgery until 24 hours after end of surgery)
- Intraoperative hypotension(up to 1hour from the initiation of sedative administration)
- Duration of nerve block(From end of surgery until 24 hours after end of surgery)
研究者
Hajung Kim
clinical assistant professor
Asan Medical Center