Dexmedetomidine Versus Propofol in Conjunction With Regional Block for Shoulder Arthroscopy: a Randomized Controlled Double Blind Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- SBP
研究概览
简要总结
Operative shoulder arthroscopy under regional block anesthesia often presents with hemodynamic challenges for the anesthesiologist, knowing that a low systolic blood pressure is required to minimize the bleeding. Regional anesthesia is successfully performed to many patients in whom tracheal intubation or the placement of a laryngeal tube is undesired. Propofol has traditionally been used to provide sedation in patients undergoing shoulder arthroscopy under regional anesthesia. In contrast to Propofol, Dexmedetomidine is a highly selective α-2 adrenoceptor agonist that has been shown to provide sedation, analgesia and anxiolytic effects with minimal respiratory depression. Due to the effect of both drugs on blood pressure, the investigators set out to compare intraoperative hemodynamics of both drugs, along with the surgeon's satisfaction and the degree of comfort provided to patients undergoing interscalene brachial plexus block for shoulder arthroscopy. The investigators also assessed whether the type of anesthetic agent used for sedation accounted for other differences in intra and post-operative outcome measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
surgeons, patients as well as the outcome assessor were blinded in regards of the drug used for sedation during surgery (Propofol vs dexmedetomidine)
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 score (ASA) I or II.
- •Elective Shoulder arthroscopy.
排除标准
- •Allergies to any of the used medications.
- •ASA score of III or above.
- •Cardiac abnormalities.
- •Contraindications to regional blocks.
- •Patient refusal.
研究组 & 干预措施
Propofol
Patients programmed for elective Shoulder arthroscopy surgery will receive a continuous intravenous infusion of Propofol. Infusion will be started after regional block (interscalene) being performed and will be continued to the end of wound closure. Infusion will be started at 2mg/Kg/h and modified to a maximum of 4 mg/Kg/h in order to achieve a bispectral index (BIS) between 60 and 90 and a Ramsay sedation score between two and four.
干预措施: Shoulder Arthroscopy (Procedure)
Propofol
Patients programmed for elective Shoulder arthroscopy surgery will receive a continuous intravenous infusion of Propofol. Infusion will be started after regional block (interscalene) being performed and will be continued to the end of wound closure. Infusion will be started at 2mg/Kg/h and modified to a maximum of 4 mg/Kg/h in order to achieve a bispectral index (BIS) between 60 and 90 and a Ramsay sedation score between two and four.
干预措施: Regional Block (Procedure)
Propofol
Patients programmed for elective Shoulder arthroscopy surgery will receive a continuous intravenous infusion of Propofol. Infusion will be started after regional block (interscalene) being performed and will be continued to the end of wound closure. Infusion will be started at 2mg/Kg/h and modified to a maximum of 4 mg/Kg/h in order to achieve a bispectral index (BIS) between 60 and 90 and a Ramsay sedation score between two and four.
干预措施: Propofol (Drug)
Propofol
Patients programmed for elective Shoulder arthroscopy surgery will receive a continuous intravenous infusion of Propofol. Infusion will be started after regional block (interscalene) being performed and will be continued to the end of wound closure. Infusion will be started at 2mg/Kg/h and modified to a maximum of 4 mg/Kg/h in order to achieve a bispectral index (BIS) between 60 and 90 and a Ramsay sedation score between two and four.
干预措施: BIS (Diagnostic Test)
Dexmedetomidine
Patients programmed for elective Shoulder arthroscopy surgery will receive a continuous intravenous infusion of Dexmedetomidine. Infusion will be started after regional block (interscalene) being performed and will be continued to the end of wound closure. Infusion will be started at 1mcg/kg over 10 minutes then 0.2 mcg/Kg/h and modified to a maximum of 0.7 mcg/Kg/h in order to achieve a bispectral index (BIS) between 60 and 90 and a Ramsay sedation score between two and four with a maximum.
干预措施: Shoulder Arthroscopy (Procedure)
Dexmedetomidine
Patients programmed for elective Shoulder arthroscopy surgery will receive a continuous intravenous infusion of Dexmedetomidine. Infusion will be started after regional block (interscalene) being performed and will be continued to the end of wound closure. Infusion will be started at 1mcg/kg over 10 minutes then 0.2 mcg/Kg/h and modified to a maximum of 0.7 mcg/Kg/h in order to achieve a bispectral index (BIS) between 60 and 90 and a Ramsay sedation score between two and four with a maximum.
干预措施: Regional Block (Procedure)
Dexmedetomidine
Patients programmed for elective Shoulder arthroscopy surgery will receive a continuous intravenous infusion of Dexmedetomidine. Infusion will be started after regional block (interscalene) being performed and will be continued to the end of wound closure. Infusion will be started at 1mcg/kg over 10 minutes then 0.2 mcg/Kg/h and modified to a maximum of 0.7 mcg/Kg/h in order to achieve a bispectral index (BIS) between 60 and 90 and a Ramsay sedation score between two and four with a maximum.
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine
Patients programmed for elective Shoulder arthroscopy surgery will receive a continuous intravenous infusion of Dexmedetomidine. Infusion will be started after regional block (interscalene) being performed and will be continued to the end of wound closure. Infusion will be started at 1mcg/kg over 10 minutes then 0.2 mcg/Kg/h and modified to a maximum of 0.7 mcg/Kg/h in order to achieve a bispectral index (BIS) between 60 and 90 and a Ramsay sedation score between two and four with a maximum.
干预措施: BIS (Diagnostic Test)
结局指标
主要结局
SBP
时间窗: at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
Change in Systolic Blood Pressure from iSBP
MAP
时间窗: at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion
change in Mean Arterial blood Pressure from iMAP
Surgeon Satisfaction: Global satisfaction scale
时间窗: up to 1 hour after surgery completion
Global satisfaction of the surgeon regarding anesthesia and patient immobility on a scale from 0 (not satisfied) to 10 (completely satisfied) collected at the end of surgery
Estimation of Bleeding
时间窗: up to 1 hour after surgery completion
Surgeon's evaluation of the bleeding that had affected the surgeon's visibility on a scale from 0 (no bleeding) to 5 (very intense bleeding) collected at the end of surgery
Occurence of Hypotension
时间窗: up to 0 minutes after admission to the Post Anesthesia Care Unit (PACU)
number of episodes of hypotension ( a drop of systolic blood pressure \>30% of the initial value recorded at patient arrival to the operating theatre)
iMAP
时间窗: Hour 0
initial Mean Arterial blood Pressure (iMAP) measurement at arrival to the operating room. Hour 0 is the time of patient's arrival to the operating room.
iSBP
时间窗: Hour 0
initial Systolic Blood Pressure (iSBP) measurement at arrival to the operating room. Hour 0 is the time of patient's arrival to the operating room.
次要结局
- RR(at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion)
- PS2: scale(up to 3 hours after surgery completion)
- PS3: scale(up to 3 hours after surgery completion)
- PS4: scale(up to 3 hours after surgery completion)
- PON(up to 3 hours after surgery completion)
- POV(up to 3 hours after surgery completion)
- Need for rescue analgesia: RA(up to 3 hours after surgery completion)
- BPM(at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion)
- SaO2(at 10 minutes interval from the beginning up to 0 minutes after the end of Propofol or Dexmedetomidine infusion)
- Vasopressors OR(up to 0 minutes after admission to the PACU)
- Vasopressors PACU(up to 3 hours after surgery completion)
- tBIS(up to 0 minutes after the end of Propofol or Dexmedetomidine infusion)
- PS1: scale(up to 3 hours after surgery completion)
- ALDRETE score(up to 3 hours after surgery completion)
- VASi(up to 10 minutes after admission to the PACU)
- VASd(up to 3 hours after surgery completion)
- Occurence of Bradycardia(up to 0 minutes after admission to the PACU)
研究者
Hicham Abou Zeid
Assistant Professor
Saint-Joseph University