Dexmedetomidine Infusion as an Analgesic Adjuvant During Laparoscopic Cholecystectomy: Randomized Controlled Study
试验速览
- 阶段
- 3 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- number of patients with severe pain
研究概览
简要总结
The aim of this study was to evaluate efficacy and safety of dexmedetomidine infusion during laparoscopic cholecystectomy. The randomized, single-center, controlled study was carried out from May 2016 to June 2017 at department of surgery, anesthesiology and intensive care, Postgraduate Institute of Bogomolets National Medical University.
详细描述
Dexmedetomidine provide sedative, sympatholytic and analgesic effect, so it could be used as an adjuvant to improve analgesia, hemodynamic response to intubation and pneumoperitoneum, decrease the number of opioid-associated adverse effects.
The aim of this study was to evaluate efficacy and safety of dexmedetomidine infusion during laparoscopic cholecystectomy.
The randomized, single-center, controlled study was carried out from May 2016 to June 2017 at department of surgery, anesthesiology and intensive care, Postgraduate Institute of Bogomolets National Medical University. Study design was approved by Ethical Committee at Bogomolets National Medical University (approval code 56).
60 patients elected for LCE were included in the study. The inclusion criteria were: age between 18 and 79 years, either sex, American Society of Anesthesiology (ASA) physical status I to II. The exclusion criteria were age outside the specified range, pregnancy or lactation, severe systemic disease (ASA III physical status), patients on b-blockers or calcium channel blockers.
After the primary patient assessment, eligible participants were assigned in a 1:1 ratio to either the intervention (Group D) or control (Group C) groups using random assignment in blocks of four. The randomization sequence was generated using a computer algorithm [19]. Randomization and data analysis were conducted by an independent blinded member of the research team.
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
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients elected for laparoscopic cholecystectomy
- •age between 18 and 79 years
- •either sex
- •ASA physical status I to II
排除标准
- •age outside the specified range
- •pregnancy or lactation
- •severe systemic disease (ASA III physical status or more)
- •patients on b-blockers or calcium channel blockers
研究组 & 干预措施
Group D
Group D received dexmedetomidine infusion 0,5 mcg/kg/h from induction in anesthesia to extubation
干预措施: Dexmedetomidine (Drug)
Croup C
group C (control) received normal saline infusion
干预措施: Normal Saline Flush, 0.9% Injectable Solution_#1 (Drug)
结局指标
主要结局
number of patients with severe pain
时间窗: 48 hours after surgery
number of patients with severe pain estimated as VAS≥7 during 30% or more time in first 48 hours after surgery
Time to first rescue analgesia
时间窗: 24 hours after surgery
time from end of anesthesia to the time postoperatively when patient ask for analgesia or have VAS≥4
morphine consumption
时间窗: 48 hours
total morphine consumption after surgery in mg
次要结局
- Incidence of chronic postoperative pain(6 month after surgery)
- Time of extubation(24 hours after surgery)
研究者
Kateryna Bielka
assistant professor at Anesthesiology and intensive care Department
Bogomolets National Medical University