Effects of Penehyclidine in Preventing Postoperative Nausea and Vomiting in Patients Underging Bimaxillary Surgery: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 354
- 试验地点
- 1
- 主要终点
- Incidence of nausea and vomiting within 72 hours after bimaxillary surgery.
研究概览
简要总结
Postoperative nausea and vomiting (PONV) is a common complication after surgery. Patients undergoing orthognathic surgery are reported to have a high rate of PONV, especially those undergoing bimaxillary surgery. Activation of cholinergic system plays an important role in the development of PONV. Penehyclidine is an muscarinic antagonists which selectively block M1 and M3 receptors and is commonly used to decrease oral secretion. The investigators hypothesize that continuously administrated penehyclidine during perioperative period can reduce the incidence of PONV in patients undergoing bimaxillary surgery.
详细描述
Postoperative nausea and vomiting (PONV) is one of the most frequently occurred complications after surgery, and are associated with patients' dissatisfaction after anesthesia and surgery. Orthognathic surgery is widely performed for the correction of dentofacial deformities. Despite of improved anti-emetic prophylaxis, patients undergoing orthognathic surgery are reported to have a high incidence of PONV, especially those after bimaxillary surgery.
It is known that activation of central cholinergic system plays an important role in the development of PONV. Muscarinic antagonists such as scopolamine can block muscarinic receptors in the cerebral cortex and produce anti-emetic effects. Penehyclidine is a new muscarinic antagonists which selectively block M1 and M3 receptors. Our previous study indicated that single-dose of penehyclidine injected before anesthesia induction was associated with a reduced risk of PONV during the first 6 h postoperatively.The mean elimination half-life of penehyclidine following single administration is about 10.35 h. Hence, a single-dose penehyclidine may only produce a short duration of antiemetic effect.
The investigators hypothesize that continuously administrated penehyclidine during perioperative period reduces PONV more effectively than single-dose injection in patients undergoing bimaxillary surgery. The purpose of this study is to investigate the effect of continuous administered penehyclidine in preventing PONV in patients undergoing bimaxillary surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years but <60 years; body mass index ≥18 but <30 kg/m2;
- •Scheduled to undergo elective bimaxillary surgery under general anesthesia;
- •Planned to use patient-controlled intravenous analgesia (PCIA) after surgery;
- •Provide written informed consents.
排除标准
- •Presence of glaucoma;
- •Allergic to penehyclidine, atropine, scopolamine or other anticholinergic drugs;
- •Acute or chronic nausea and/or vomiting, or gastrointestinal motility disorders before surgery;
- •Preoperative antiemetic therapy within 12 hours;
- •History of schizophrenia, Parkinson's disease or profound dementia, or language barrier;
- •Severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (requirement of renal replacement therapy before surgery) or American Society of Anesthesiologists physical status ≥IV.
研究组 & 干预措施
Control group
For patients in the control group, a dose of placebo (normal saline 5 ml) is injected intravenously before anesthesia induction. A patient-controlled intravenous analgesia pump is provided after surgery, which is established with a mixture of placebo (normal saline 5 ml), sufentanil (1.25-1.5 ug/kg) and tropisetron 10 mg, diluted with normal saline to 100 ml, and programmed to administer a continuous infusion at a rate of 2 ml/h for 48 hours.
干预措施: Placebo (Drug)
Single injection group
For patients in this group, a dose of penehyclidine (0.5 mg/5 ml) is injected intravenously before anesthesia induction. A patient-controlled intravenous analgesia pump is provided after surgery, which is established with a mixture of placebo (normal saline 5 ml), sufentanil (1.25-1.5 ug/kg) and tropisetron (10 mg), diluted with normal saline to 100 ml, and programmed to administer a continuous infusion at a rate of 2 ml/h for 48 hours.
干预措施: Single injection of penehyclidine (Drug)
Continuous infusion group
For patients in this group, a dose of penehyclidine (0.25 mg/5 ml) is injected intravenously before anesthesia induction. A patient-controlled intravenous analgesia pump is provided after surgery, which is established with a mixture of penehyclidine (0.25 mg/5 ml), sufentanil (1.25-1.5 ug/kg) and tropisetron (10 mg), diluted with normal saline to 100 ml, and programmed to administer a continuous infusion at a rate of 2 ml/h for 48 hours.
干预措施: Continuous infusion of penehyclidine (Drug)
结局指标
主要结局
Incidence of nausea and vomiting within 72 hours after bimaxillary surgery.
时间窗: Up to 72 hours after surgery.
Nausea was assessed by direct questioning. Vomiting was diagnosed when patients retched or expulsed intra-gastric contents.
次要结局
- Length of stay in hospital after surgery.(Up to 30 days after surgery.)
- Severity of nausea and vomiting within 72 hours after bimaxillary surgery.(Up to 72 hours after surgery.)
- Incidence of delirium within the first 5 days after surgery(Up to 5 days after surgery.)
- Incidence of complications within 30 days after surgery.(Up to 30 days after surgery.)
- Incidence of nausea and vomiting at different stages after bimaxillary surgery.(Up to 72 hours after surgery.)
- Incidence of moderate to severe nausea at different stages after bimaxillary surgery.(Up to 72 hours after surgery.)
- Incidence of moderate to severe nausea within 72 hours after bimaxillary surgery.(Up to 72 hours after surgery.)
- Use of rescue antiemetics within 72 hours after bimaxillary surgery.(Up to 72 hours after surgery.)
- All-cause 30-day mortality.(Within 30 days after surgery.)
- Cognitive function on the 30th day after surgery.(At 30 days after surgery)
研究者
Dong-Xin Wang
Professor and Chairman, Department of Anaesthesiology and Critical Care Medicine
Peking University First Hospital