Effects of Penehyclidine on Postoperative Nausea and Vomiting in Patients Underging Bimaxillary Surgery: A Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 243
- 试验地点
- 1
- 主要终点
- Postoperative nausea and vomiting (PONV) within 48 hours after bimaxillary surgery.
研究概览
简要总结
Postoperative nausea and vomiting (PONV) are common complications 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 purpose of this retrospective cohort study is to investigate whether use of penehyclidine is associated with a reduced risk of PONV in patients undergoing bimaxillary surgery.
详细描述
Postoperative nausea and vomiting (PONV) are one of the most frequent complications after surgery, and are associated with patients' dissatisfaction after anesthesia and surgery. Orthognathic surgery is widely performed for the correction of dentofacial deformities. PONV is common after orthognathic surgery. 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. It has fewer adverse effects compared with other anticholinergics. The purpose of this retrospective cohort study is to investigate whether use of penehyclidine is associated with a reduce risk of PONV in patients undergoing bimaxillary surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥16 years;
- •Underwent elective bimaxillary surgery under general anesthesia.
排除标准
- •Age <16 years;
- •Missing data.
研究组 & 干预措施
Penehyclidine group
Penehyclindine hydrochloride was administered before anesthesia induction.
干预措施: Penehyclidine hydrochloride (Drug)
Placebo group
Penehyclindine hydrochloride was not administered before anesthesia induction.
干预措施: No penehyclidine hydrochloride (Other)
结局指标
主要结局
Postoperative nausea and vomiting (PONV) within 48 hours after bimaxillary surgery.
时间窗: Up to 48 hours after surgery.
Nausea was assessed by direct questioning. Vomiting was diagnosed when patients retched or expulsed intra-gastric contents.
次要结局
- In-hospital mortality after surgery.(Up to 30 days after surgery.)
- Postoperative agitation after bimaxillary surgery.(Up to 8:00 am on the first day after surgery.)
- Postoperative complications during hospital stay after surgery.(Up to 30 days after surgery.)
- Daily prevalence of PONV.(Up to 48 hours after surgery.)
- Postoperative pain after bimaxillary surgery.(Up to 2 days after surgery.)
- Length of stay in hospital after surgery.(Up to 30 days after surgery.)
研究者
Dong-Xin Wang
Professor and Chairman, Department of Anaesthesiology and Critical Care Medicine
Peking University First Hospital