Penehyclidine for Prevention of Nausea and Vomiting After Bimaxillary Surgery
Condition: Penehyclidine; Postoperative Nausea and Vomiting; Bimaxillar Surgery
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Single injection of penehyclidine; Continuous infusion of penehyclidine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A dose of penehyclidine hydrochloride (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.; A dose of penehyclidine hydrochloride (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 hydrochloride (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.; 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.
Other intervention name(s): Penehyclidine hydrochloride; Penehyclidine hydrochloride; Normal saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Penehyclidine; Postoperative Nausea and Vomiting; Bimaxillar Surgery