Effect of Dexmedetomidine on Sevoflurane Minimum Alveolar Concentration for Attenuating Adrenergic Response to CO2 Pneumoperitoneum: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Minimum alveolar concentration of sevoflurane to block the adrenergic response (MAC-BAR)
研究概览
简要总结
This clinical trial aims to learn the impact of dexmedetomidine on the minimum alveolar concentration blunting the adrenergic response (MAC-BAR) of sevoflurane to carbon dioxide pneumoperitoneum in patients undergoing laparoscopic cholecystectomy. It will also learn about the effect of dexmedetomidine on hemodynamic parameters. The main questions are:
- Does dexmedetomidine reduce the MAC-BAR of sevoflurane required to suppress the sympathetic response to carbon dioxide pneumoperitoneum?
- Would dexmedetomidine administration dose-dependently reduce the minimum alveolar concentration blunting the adrenergic response of sevoflurane required to suppress the sympathetic response to carbon dioxide pneumoperitoneum? Researchers will compare low-dose dexmedetomidine to high-dose dexmedetomidine to see if dexmedetomidine works to treat postoperative negative behavior change and emergence delirium.
Participants will:
- Take intravenous dexmedetomidine or 0.9% saline (a look-alike substance that contains no drug)
- Study drug infusions were initiated 15 minutes prior to anesthesia induction, allowing a minimum of 30 minutes to elapse before surgical incision to achieve steady-state plasma and brain concentrations.
详细描述
Laparoscopic (minimally invasive) surgery has several advantages over open surgery, including less tissue damage, faster recovery, and fewer complications. This has led to widespread use of laparoscopic techniques. However, the inflated carbon dioxide gas used to create the surgical space during laparoscopic surgery causes significant changes in the body's normal blood pressure and heart function.
The anesthetic drug sevoflurane is commonly used during these procedures, but higher doses are needed to adequately block the body's stress response to the inflated gas. The minimum alveolar concentration blunting the adrenergic response (MAC-BAR) measures the minimum anesthetic depth required to suppress the sympathetic/stress response in 50% of patients. Doctors use MAC-BAR values to help determine the appropriate anesthetic dose to maintain hemodynamic stability. Unfortunately, using higher sevoflurane doses to reach the necessary MAC-BAR increases the risk of low blood pressure, reduced heart function, and confusion after surgery.
The drug dexmedetomidine has properties that can help manage the body's stress response during surgery. Researchers wanted to see if dexmedetomidine could allow the use of lower, more stable doses of sevoflurane during laparoscopic procedures by reducing the body's reaction to the inflated gas.
The goal of this study was to evaluate how dexmedetomidine affects the MAC-BAR of sevoflurane needed to block the sympathetic/stress response to the inflated gas used in laparoscopic surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-45 years.
- •American Society of Anesthesiologists (ASA) grade I - II.
- •Patients undergoing elective laparoscopic cholecystectomy.
排除标准
- •Inability to provide informed consent;
- •History of chronic pain or substance abuse;
- •Body mass index (BMI) ≥ 30 kg/m2;
- •Known allergies to the study medications;
- •Intake of medications within the last 72 hours that potential interfere with the determination of the MAC-BAR;
- •Any other condition deemed exclusionary by the investigators.
研究组 & 干预措施
Control group
The control group received volume-matched 0.9% saline infusions at identical rates.
干预措施: normal Saline (Drug)
Low-dose dexmedetomidine group
The low-dose dexmedetomidine group received a 75 μg/h loading dose over 15 minutes, followed by 60 μg/h maintenance infusion intravenously.
干预措施: Dexmedetomidine low-dose (Drug)
High-dose dexmedetomidine group
The high-dose dexmedetomidine group received a 150 μg/h loading dose over 15 minutes, followed by 120 μg/h maintenance infusion intravenously.
干预措施: Dexmedetomidine high-dose (Drug)
结局指标
主要结局
Minimum alveolar concentration of sevoflurane to block the adrenergic response (MAC-BAR)
时间窗: Within 30 minutes after intubation
The MAC-BAR of sevoflurane for each group was determined using an up-and-down sequential allocation technique. One minute after establishing a stable pneumoperitoneum, the sympathetic adrenergic response was evaluated by changes in heart rate and mean artery pressure from pre-insufflation baseline values. A positive response was defined as a ≥ 20% increase in either heart rate or mean artery pressure from baseline.
次要结局
- Change in mean arterial pressure(Upon arrival in the operating room, at 3, 1 minutes before pneumoperitoneum and 1, 3 minutes after pneumoperitoneum)
- Change in heart rate(Upon arrival in the operating room, at 3, 1 minutes before pneumoperitoneum and 1, 3 minutes after pneumoperitoneum)
- Incidence of adverse events(Up to 24 hours postoperatively)
研究者
Yao Yusheng
Professor
Fujian Provincial Hospital