Comparison of Dexmedetomidine and Dexamethasone for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Controlled Trial
概览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Patel Hospital, Pakistan
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- The PONV scores over the 24-hour period
概览
简要总结
Postoperative nausea and vomiting (PONV) remains a common and distressing complication after laparoscopic cholecystectomy despite advances in anesthesia. Both dexmedetomidine and dexamethasone have shown antiemetic properties, but their comparative effectiveness is still debated. To compare the efficacy of dexmedetomidine and dexamethasone in preventing PONV in patients undergoing laparoscopic cholecystectomy.
This double-blind randomized controlled trial included 68 ASA I-II patients scheduled for elective laparoscopic cholecystectomy. Patients were randomly allocated to receive either intravenous dexmedetomidine (1 μg/kg) or dexamethasone (8 mg) after induction of anesthesia. PONV was assessed using a standardized scoring system on arrival in the PACU and at 4, 12, and 24 hours postoperatively. Ondansetron was administered as rescue antiemetic when required.
This study aims to determine the more effective prophylactic agent for PONV, with the goal of improving postoperative comfort and quality of care in patients undergoing laparoscopic surgery in the local population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both male and female patients will be included
- •Patient between the age of 18 to 60 years.
- •Patient undergoing elective Laparoscopic Cholecystectomy.
- •Patients with American Society of Anesthesiologists (ASA) physical status I and II.
排除标准
- •Patient not willing to participate in study.
- •Patients with a history of allergy to dexmedetomidine and dexamethasone.
- •Patients having motion sickness and history of PONV in past anesthesia experience.
- •Patients receiving antiemetic drugs during the last 48 hours before laparoscopic cholecystectomy.
- •Patients with body mass index ≥ 30 kg/m2
- •Patients with emergency laparoscopic cholecystectomy.
- •Laparoscopic cholecystectomy lasts for more than one hour.
- •Laparoscopic cholecystectomy converting to open cholecystectomy.
研究组 & 干预措施
Dexmedetomidine group
Intravenous dexmedetomidine administered perioperatively for prevention of postoperative nausea and vomiting.
干预措施: Dexamedomedine (Drug)
Dexmathasone group
Intravenous dexamethasone administered perioperatively for prevention of postoperative nausea and vomiting.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
The PONV scores over the 24-hour period
时间窗: From arrival in the post-anesthesia care unit (0 hours) through 24 hours after surgery, assessed at 0, 4, 12, and 24 hours postoperatively.
PONV will be assessed using the Postoperative Nausea and Vomiting (PONV) Scoring Scale (range: 0-3; higher scores indicate worse outcome, where 0 = no nausea/vomiting and 3 = vomiting ≥3 episodes/day). Assessments will be performed at predefined time points: upon arrival in PACU (0 hours), 4 hours, 12 hours, and 24 hours postoperatively.
次要结局
未报告次要终点
研究者
Marium Rafiq
Resident Trainee, Department of Anaesthesiology, Principal Investigator
Patel Hospital, Pakistan