Oral Dexamethasone at Night to Prevent Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy: A Protocol for Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 814
- 试验地点
- 1
- 主要终点
- Postoperative nausea or vomiting (PONV)
研究概览
简要总结
Postoperative nausea and vomiting (PONV) are common complications after laparoscopic cholecystectomy. This study aims to evaluate the efficacy of the administration of prophylactic oral dexamethasone at night before surgery in preventing PONV after elective laparoscopic cholecystectomy.
详细描述
Background:
Postoperative nausea and vomiting (PONV) are common complications after laparoscopic cholecystectomy. This study aims to evaluate the efficacy of the administration of prophylactic oral dexamethasone 12 hours before induction of anesthesia in preventing PONV after elective laparoscopic cholecystectomy, as it reaches its peak effect at 2-12 hours and lasts for 72 hours after oral administration.
Methods:
This is a parallel, two-arm, randomized (1:1), controlled, single-center non-inferiority trial. Adults (≥18 years) with ASA physical status I-III scheduled for elective laparoscopic cholecystectomy will be eligible for inclusion. The participants will be randomized to receive either 8 mg of IV Dexamethasone at the time of induction of anesthesia or 8 mg of oral Dexamethasone 12 hours before induction of anesthesia. The primary outcome will be the incidence of postoperative nausea and vomiting. A total of 814 patients are intended to be recruited for this non-inferiority trial.
Discussion:
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 (Outcomes Assessor)
盲法说明
The outcome assessors will be blinded to the group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all consecutive adults (older than 18 years) with ASA physical status I-III undergoing elective laparoscopic cholecystectomy surgery.
排除标准
- •steroids or antiemetics within 1 week of surgery
- •chronic opioid therapy
- •history of allergy to any of the study drug
- •serum creatinine > 1.4 mg/dl
- •liver enzymes > triple the normal limits
- •pregnancy
- •patient refusal
- •and psychiatric or neurologic diseases or socioeconomic status that would hinder the postoperative quality of recovery questionnaire
- •laparoscopic surgery is converted to open surgery after enrollment
研究组 & 干预措施
At-night oral dexamethasone
Patients in the intervention group will receive oral 8 mg dexamethasone at night before surgery. The time of dexamethasone administration will be recorded.
干预措施: Dexamethasone Oral (Drug)
At-induction dexamethasone
Patients in the control group will receive intravenous 8 mg dexamethasone just before or at the induction of anesthesia. The dexamethasone ampule will be diluted in a 10 ml syringe and given in at least one minute to avoid unpleasant sensations in injection.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Postoperative nausea or vomiting (PONV)
时间窗: 24 hours after surgery
incidecne of PONV
次要结局
- Rescue antiemetic(24 hours after surgery)
- Early PONV(within 6 hours after surgery)
- Visual Analogue Scale (VAS) at the time of discharge from PACU(within 2 hours at the time of discharge from PACU)
- Post-Discharge Nausea and Vomiting (PDNV)(72 hours after surgery.)
- Late PONV(6 - 24 hours after surgery)
- Postoperative fatigue(after 24 hours at the time of discharge from the hospital)
- Postoperative quality of recovery(after 24 hours at the time of discharge from the hospital)
- VAS at the time of discharge from hospital(after 24 hours at the time of discharge from the hospital)