Effect of Intravenous Dexmedetomidine on the Analgesic Duration of Infraclavicular Block With Ropivacaine for Upper Limb Surgery: a Prospective, Randomized, Double Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The duration of sensory infraclavicular block in patients scheduled for upper limb surgery.
研究概览
简要总结
The study will evaluate the effect of Dexmedetomidine sedation on the duration of infraclavicular block in patients scheduled for surgery of elbow, forearm and/or hand. All patients will receive infraclavicular block before the surgery and then they will be randomized to receive either Dexmedetomidine or Propofol sedation. Duration of the sensory block will be evaluated in recovery room, 24 and 48 hours after the surgery.
Hypothesis:
Primary: Dexmedetomidine sedation increases the duration of sensory infraclavicular block in patients scheduled for upper limb surgery.
Secondary: Dexmedetomidine sedation
- Gives an adequate level of sedation during the surgical procedure
- Reduces the requirements of postoperative opioids
- Improves the quality of sleep on the night of the surgery
- Increases patients satisfaction regarding the anesthesia technique
- Dexmedetomidine sedation is safe and easy to use
- Dexmedetomidine sedation provides less respiratory depression during the procedure.
详细描述
Methodology:
Study design A randomized, prospective, double blind study.
Patient groups Group 1 (control group) This group will have infraclavicular block and sedation during surgery with intravenous Propofol.
Group 2 (intervention group) This group will have infraclavicular block and sedation with intravenous Dexmedetomidine.
Recruitment and Informed consent: Recruitment will take place in the preoperative clinic or surgical day care unit.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and females of 16-80 years of age, scheduled for hand, forearm and elbow ambulatory surgery with an infraclavicular block.
- •American Society of Anesthesiologist (ASA) Class I, II, III
- •Ability to cooperate with study related procedures
排除标准
- •Narcotic dependent (opioid intake more than 3 months) or chronic pain conditions
- •Associated significant cardiac or respiratory disease, neurological deficits
- •Coexisting hematological disorder or with deranged coagulation
- •Pre-existing major organ dysfunction
- •Psychiatric illnesses
- •Emergency surgery
- •Lack of informed consent
- •Allergy to any of the drugs used in the study
- •Surgical procedure duration greater than 3 hours
研究组 & 干预措施
Propofol sedation.
This group will have infraclavicular block and sedation during surgery with intravenous Propofol. Patients will receive intravenous Propofol sedation 50-100 mcg/kg/min infusion. The infusion will be stopped 15 minutes before the end of surgery.
干预措施: Propofol (Drug)
Propofol sedation.
This group will have infraclavicular block and sedation during surgery with intravenous Propofol. Patients will receive intravenous Propofol sedation 50-100 mcg/kg/min infusion. The infusion will be stopped 15 minutes before the end of surgery.
干预措施: Infraclavicular block (Procedure)
Dexmedetomidine sedation.
This group will have infraclavicular block and sedation with intravenous Dexmedetomidine. Patients will receive intravenous Dexmedetomidine sedation bolus 0.5mcg/kg in 10 minutes and then 0.2-0.5 mg/kg/hr infusion. The infusion will be stopped 15 minutes before the end of surgery.
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine sedation.
This group will have infraclavicular block and sedation with intravenous Dexmedetomidine. Patients will receive intravenous Dexmedetomidine sedation bolus 0.5mcg/kg in 10 minutes and then 0.2-0.5 mg/kg/hr infusion. The infusion will be stopped 15 minutes before the end of surgery.
干预措施: Infraclavicular block (Procedure)
结局指标
主要结局
The duration of sensory infraclavicular block in patients scheduled for upper limb surgery.
时间窗: The primary outcome will be the duration of the sensory infraclavicular block in minutes, from the moment that the block is perfomed and the moment of first analgesic request.
In the data collection form will be record the time of performance of the infraclavicular block. The patients will have a diary where they will record the time of the day when day have the first analgesic request because of pain in the surgical site.
次要结局
未报告次要终点
研究者
Shalini Dhir
Principal Investigator
Lawson Health Research Institute