Penehyclidine for Prevention of Nausea and Vomiting After Bimaxillary Surgery

  • STATUS
    Recruiting
  • participants needed
    354
  • sponsor
    Peking University First Hospital
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Updated on 16 February 2024
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body mass index
anesthesia
analgesia
nausea
orthognathic surgery
vomit
postoperative nausea
cholinergic system
penehyclidine

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.

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.

Details
Condition Vomiting, Vomiting, Postoperative Nausea, Penehyclidine, Bimaxillar Surgery
Age 18years - 59years
Treatment Placebo, Single injection of penehyclidine, Continuous infusion of penehyclidine
Clinical Study IdentifierNCT04454866
SponsorPeking University First Hospital
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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