Dexamethasone At-induction vs At-night to Prevent Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy: A Protocol for Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- postoperative nausea or vomiting (PONV)
研究概览
简要总结
Since the peak effect of the dexamethasone is delayed to 12-16 hours after iv administration, we designed this study to investigate the effect of administering dexamethasone at-night before surgery versus at-induction (the standard timing) in prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy.
A pilot randomized controlled study (60 cases) will be started to explore the potential difference, ensure correct and rigorous data collection, and calculate the sample size for a larger pragmatic trial.
详细描述
Background:
Postoperative nausea and vomiting (PONV) are common complications after laparoscopic cholecystectomy. The aim of this study is to evaluate the efficacy of administration of prophylactic dexamethasone 12-hours prior to 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 intravenous (iv) administration.
Methods:
This is a parallel two-arm, randomized (1:1), double-blind, controlled, single-center trial. Adults (≥18 years) with American Society of Anesthesiology (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 IV Dexamethasone at time of induction of anesthesia or 8 mg IV Dexamethasone at 12 hours prior to induction of anesthesia. The primary outcome will be the incidence of postoperative nausea and vomiting. A total of 60 patients will be recruited as a pilot study.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
The pharmacists will prepare the study drug, either dexamethasone or saline in 10 mL similar syringes, according to the allocation. The syringe will be labeled with the patient's name and the allocation group, A or B. The study participants, caregivers, data collectors, and data analysts will all be blinded. The pharmacists will not participate in the study.
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 at gastrointestinal surgery center.
排除标准
- •patient refusal
- •use of steroids or antiemetic agents within 1 week of surgery
- •chronic opioid therapy
- •history of allergy to any study medications
- •serum creatinine > 1.4 mg/dl
- •liver enzymes more than triple normal limits
- •pregnancy
- •psychiatric or neurologic diseases or socioeconomic status that would hinder postoperative quality of recovery questionnaire
- •Patients whose laparoscopic surgery is converted to open surgery after enrollment will be excluded.
研究组 & 干预措施
At-night dexamethasone
Patients in the intervention group will receive intravenous 8 mg dexamethasone at night before surgery. The time of dexamethasone administration will be recorded. The dexamethasone ampule will be diluted in a 10 ml syringe and given in at least one minute to avoid unpleasant sensation in injection.
干预措施: At-night Dexamethasone (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 sensation in injection.
干预措施: At-induction Dexamethasone (Drug)
结局指标
主要结局
postoperative nausea or vomiting (PONV)
时间窗: 24 hours after surgery
incidence of PONV (binary outcome as yes/No)
次要结局
- The need for rescue analgesia(24 hours after surgery)
- Postoperative Care Unit (PACU) and Early PONV(within 6 hours after surgery)
- Late PONV(6-24 hours after surgery)
- Visual Analogue Scale (VAS)(at the time of discharge from hospital (usually 24 hours after surgery))
- The need for rescue antiemetic(24 hours after surgery)
- Postoperative quality of recovery (QoR)(24 hours after surgery)
- Post-Discharge Nausea and Vomiting (PDNV)(at 72 hours after surgery)