Effect of a Preoperative Single Dose of Intravenous Dexamethasone on Postoperative Vomiting in Patients Undergoing Laparoscopic Gynecologic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Incidence of postoperative vomiting
研究概览
简要总结
Postoperative nausea and vomiting (PONV) are common and distressing complications following laparoscopic gynecologic surgery. This randomized controlled trial evaluated whether a single preoperative intravenous dose of dexamethasone reduces postoperative vomiting compared with placebo and explored patient-related risk factors associated with PONV.
Women undergoing elective laparoscopic gynecologic surgery were randomly assigned to receive dexamethasone (5 mg IV) or placebo at induction of anesthesia. The primary outcome was the incidence of postoperative vomiting within 24 hours, with secondary outcomes including nausea severity, rescue antiemetic use, and postoperative recovery parameters.
详细描述
This single-blind randomized controlled trial evaluated the prophylactic efficacy of a single preoperative intravenous dose of dexamethasone for preventing postoperative vomiting in women undergoing elective laparoscopic gynecologic surgery. The study was conducted at Holy Family Hospital, Rawalpindi Medical University, Pakistan, between October 1, 2017, and March 31, 2018.
Eligible women aged 15-65 years were randomized in a 1:1 ratio to receive either dexamethasone 5 mg intravenously or placebo (normal saline) at induction of anesthesia. Perioperative anesthesia and postoperative care were standardized across groups. The primary outcome was the incidence of postoperative vomiting within 24 hours after surgery. Secondary outcomes included nausea severity, need for rescue antiemetics, postoperative opioid use, and recovery parameters such as time to oral intake and mobilization. An exploratory analysis assessed patient-related predictors of postoperative nausea and vomiting, including body mass index and prior history of PONV.
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
- Single (Participant)
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 15-65 years
- •Scheduled for elective laparoscopic gynecologic surgery
- •Able to provide written informed consent (for minors, consent obtained from legal guardians)
排除标准
- •Prior laparoscopic surgery
- •Known hypersensitivity to corticosteroids
- •Opioid use within 24 hours preoperatively
- •Ischemic heart disease
- •Uncontrolled hypertension or diabetes mellitus
- •Ongoing antiemetic therapy
- •Conversion to open surgery
- •Body mass index (BMI) > 30 kg/m²
研究组 & 干预措施
Dexamethasone
Single intravenous dose of dexamethasone 5 mg administered at induction of anesthesia prior to surgical incision.
干预措施: Dexamethasone (Drug)
Placebo (Normal Saline)
Single intravenous dose of normal saline (placebo) administered at induction of anesthesia.
干预措施: Placebo (Normal Saline) (Other)
结局指标
主要结局
Incidence of postoperative vomiting
时间窗: Within 24 hours after surgery
Proportion of participants experiencing at least one episode of vomiting within 24 hours after surgery.
次要结局
- Need for rescue antiemetics(Within 24 hours after surgery)
研究者
Fizza Fatima
Dr.
Rawalpindi Medical College