The Effect of Dexmedetomidine on Gastric Emptying, Assessed by Ultrasound, in Patients Undergoing Laparoscopic Cholecystectomy: A Prospective Randomized Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Assessment of gastric volume with the aid of ultrasound
研究概览
简要总结
The aim of this study is to evaluate the effect of dexmedetomidine on gastric emptying assessed by gastric ultrasound in patients undergoing laparoscopic cholecystectomy.
详细描述
Delayed return of normal gastrointestinal function, and postoperative nausea and vomiting (PONV) are common adverse events of laparoscopic cholecystectomy under general anesthesia. Sympathetic stimulation, intra-abdominal carbon dioxide insufflation, and the consequent visceral peritoneal irritation are all contributing factors. In addition, anesthetic agents and opioids can also have a harmful impact on gastric emptying.
Dexmedetomidine, a potent and highly selective alpha-2 adrenoreceptor agonist, is frequently employed as an anesthetic adjunct in surgical procedures. By reducing the surgical stress response through its central sympatholytic and anti-inflammatory effects, dexmedetomidine offers distinct organ protection. Furthermore, its opioid-sparing effect reduces the need for perioperative analgesics.
A recent meta-analysis reported a positive impact of perioperative dexmedetomidine use on postoperative gastrointestinal function by shortening the time to pass flatus.The use of gastric ultrasound to assess cross-sectional area of the stomach and it's volume may provide better insight into the effect of dexmedetomidine on gastrointestinal function.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 21 to 65 years old.
- •Both sexes.
- •American Society of Anesthesiologists (ASA) physical status I-II.
- •Undergoing elective laparoscopic cholecystectomy surgery
排除标准
- •Patient's refusal.
- •Patients with abnormalities in gastrointestinal tracts (including previous esophageal or gastric surgery, tumors or stricture).
- •Failure to follow preoperative fasting guidelines.
- •Patients with a body mass index ≥ 35
- •Patients on regular treatment of antacids or prokinetic.
- •Presence of history of disease causing an increase in the incidence of delayed gastric emptying such as: diabetes mellitus, obesity or electrolyte disturbances.
- •Pregnancy.
- •Presence of hepatic or renal dysfunction.
- •Presence of existing condition causing bradycardia such as heart block, or patients on regular calcium channel blockers or beta blockers.
研究组 & 干预措施
Dexmeditomidine group
Patients who will receive IV infusion of (0.2 µg/kg/hr dexmeditomidine).
干预措施: Dexmeditomidine (Drug)
Control group
Patients who will receive IV infusion of normal saline, at the same rate of dexmedetomidine infusion
干预措施: Normal saline (Drug)
结局指标
主要结局
Assessment of gastric volume with the aid of ultrasound
时间窗: 3 hours postoperatively
Gastric ultrasound will be used to measure gastric volume through cross-sectional area before induction, and 1 and 3 hours postoperatively. Estimated gastric volumes will be calculated using a previously validated formula: gastric volume (mL) = 27.0 + (14.6 ×CSA) - (1.28 ×Age).
次要结局
- Measurement of cross-sectional area of gastric antrum(3 hours postoperatively)
- Gastric content assessment.(3-hour post-operative marks in post anesthesia care unit (PACU).)
- Relation between gastric cross-sectional area to time of passage of flatus(24 hours postoperatively)
研究者
Noran Hesham Mohammed Elsaid Borg
Resident of Anesthesia, Surgical Intensive Care and Pain Management, Faculty of Medicine, Tanta University, Tanta, Egypt
Tanta University