Penehyclidine and Postoperative Nausea and Vomiting After Bimaxillary Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Penehyclidine on Postoperative Nausea and Vomiting in Patients Underging Bimaxillary Surgery: A Retrospective Cohort Study

Conditions
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Penehyclidine, Postoperative Nausea and Vomiting, Bimaxillar Surgery

Intervention / Treatment
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* Drug: Penehyclidine hydrochloride
* Other: No penehyclidine hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥16 years; Underwent elective bimaxillary surgery under general anesthesia. Exclusion Criteria: Age <16 years; Missing data.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Penehyclidine group<br>Penehyclindine hydrochloride was administered before anesthesia induction. | Drug: Penehyclidine hydrochloride<br>* Penehyclidine hydrochloride was administered before anesthesia induction.<br>|
| Placebo group<br>Penehyclindine hydrochloride was not administered before anesthesia induction. | Other: No penehyclidine hydrochloride<br>* Penehyclidine hydrochloride was not administered before anesthesia induction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative nausea and vomiting (PONV) within 48 hours after bimaxillary surgery. | Nausea was assessed by direct questioning. Vomiting was diagnosed when patients retched or expulsed intra-gastric contents. | Up to 48 hours after surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily prevalence of PONV. | Daily prevalence of PONV on the day of surgery, as well as the first and second day after surgery. | Up to 48 hours after surgery. | 
| Postoperative agitation after bimaxillary surgery. | Postoperative agitation was diagnosed when a Richmond Agitation-Sedation Scale (scale ranges from -5 to +4, with higher scale indicating severe agitation) reached +2 or more at any time within 2 hours after extubation. | Up to 8:00 am on the first day after surgery. | 
| Postoperative pain after bimaxillary surgery. | Postoperative pain was assessed with the Numeric Rating Scale (an 11-point scale where 0=no pain and 10=the worst pain). A score of 4 or more is defined a moderate-to-severe pain. | Up to 2 days after surgery. | 
| Postoperative complications during hospital stay after surgery. | Postoperative complications were generally defined as new-onset medical events that were harmful for patients' recovery and required therapeutic intervention. | Up to 30 days after surgery. | 
| Length of stay in hospital after surgery. | Length of stay in hospital after surgery. | Up to 30 days after surgery. | 
| In-hospital mortality after surgery. | In-hospital mortality after surgery. | Up to 30 days after surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Penehyclidine, Postoperative nausea and vomiting, Bimaxillary surgery