Prevention of Post-Operative Nausea and Vomiting With Propofol Infusion
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Nausea (urge to vomit) episodes
研究概览
简要总结
The purpose of this study is to clarify whether or not a low-dose propofol infusion can effectively prevent postoperative nausea and vomiting (PONV) in patients who have a documented history of PONV and/or motion sickness.
详细描述
Propofol is administered as both low dose and as sole anesthetic in patients with history of PONV and/or motion sickness. But efficacy of one dose over the other is not studied. This study plans to clarify if propofol in low dose is as effective as its administration as sole anesthetic in patients with history of PONV and/or motion sickness
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
- Single (Participant)
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
- •Undergoing general anesthesia for elective surgery
- •Documented history of Patient's self-disclosure of PONV and/or motion sickness during pre-anesthesia discussions
- •No documented allergy/adverse reaction to propofol
- •English speaking
- •At least 18 years of age
排除标准
- •Any anti-nausea medication taken within 24 hours prior to surgery
- •Unable to provide consent independently
- •Allergy or adverse reaction to propofol
- •Emergency surgery
研究组 & 干预措施
Hybrid anesthesia (propofol + sevoflurane)
Participants received general anesthesia maintained with a continuous low-dose propofol infusion combined with sevoflurane. Anesthetic depth was titrated to a bispectral index (BIS) target of 40-60. Standardized induction agents and prophylactic antiemetics were administered.
干预措施: Hybrid anesthesia (propofol + sevoflurane) (Drug)
Propofol only TIVA
Participants received general anesthesia maintained with propofol-based total intravenous anesthesia (TIVA). Propofol infusion was titrated to maintain a bispectral index (BIS) target of 40-60. Standardized induction agents and prophylactic antiemetics were administered
干预措施: Propofol only TIVA (Drug)
结局指标
主要结局
Nausea (urge to vomit) episodes
时间窗: 24 hours
Number of self-reported nausea episodes
Retching (labored, spasmodic, rhythmic contractions of respiratory muscles without expulsion of gastric contents) episodes
时间窗: 24 hours
Number of self-reported retching episodes
Vomiting (forceful expulsion of gastric contents) episodes
时间窗: 24 hours
Number of self-reported vomiting episodes
Number of Subjects Experiencing Post-Operative Nausea/Vomiting (PONV)
时间窗: 24 hours
Postoperative nausea and vomiting (PONV) within 24 hours was defined as any episode of nausea, retching, or vomiting occurring from PACU discharge up to 24 hours after surgery. Data were collected using standardized patient questionnaires and follow-up telephone interviews conducted at 24 hours after surgery.
次要结局
- Choice of antiemetic- Prochlorperazine(24 hours)
- Number of times metoclopramide administered(24 hours)
- Choice of antiemetic- Dexamethasone(24 hours)
- Number of times dexamethasone administered(24 hours)
- Choice of antiemetic- Ondansetron(24 hours)
- Choice of antiemetic- Promethazine(24 hours)
- Number of times promethazine administered(24 hours)
- Number of times prochlorperazine administered(24 hours)
- Number of times ondansetron administered(24 hours)
- Choice of antiemetic- metoclopramide(24 hours)
- Choice of antiemetic- Droperidol(24 hours)
- Number of times droperidol administered(24 hours)
- Choice of antiemetic- scopolamine(24 hours)
- Number of times scopolamine administered(24 hours)
- Choice of antiemetic-diphenhydramine(24 hours)
- Number of times diphenhydramine administered(24 hours)
- Episodes of Post Operative Nausea/Vomiting (PONV)(PACU)
- Use of Antiemetics(24 hours)
研究者
Revati Kanekar
Assistant Professor, Department of Anesthesiology and Perioperative Medicine
Milton S. Hershey Medical Center