Penehyclidine and Postoperative Nausea and Vomiting After Bimaxillary Surgery

Completed

• Conditions: Bimaxillar Surgery; Postoperative Nausea and Vomiting; Penehyclidine
• Interventions: Drug: Penehyclidine hydrochloride; Other: No penehyclidine hydrochloride

• Registration Number: NCT04112771
• Lead Sponsor: Peking University First Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-09-27
• Study First Submitted QC: 2019-09-30
• Study First Posted: 2019-10-02
• Study Start: 2019-10-07
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-30
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-26
• Last Update Posted: 2020-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 243

Inclusion Criteria

• Age ≥16 years;
• Underwent elective bimaxillary surgery under general anesthesia.

Exclusion Criteria

• Age <16 years;
• Missing data.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Penehyclidine group	Penehyclidine hydrochloride	Penehyclindine hydrochloride was administered before anesthesia induction.
Placebo group	No penehyclidine hydrochloride	Penehyclindine hydrochloride was not administered before anesthesia induction.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
In-hospital mortality after surgery.	Up to 30 days after surgery.	In-hospital mortality after surgery.
Postoperative agitation after bimaxillary surgery.	Up to 8:00 am on the first day after 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.
Postoperative complications during hospital stay after surgery.	Up to 30 days after surgery.	Postoperative complications were generally defined as new-onset medical events that were harmful for patients' recovery and required therapeutic intervention.
Daily prevalence of PONV.	Up to 48 hours after surgery.	Daily prevalence of PONV on the day of surgery, as well as the first and second day after surgery.
Postoperative pain after bimaxillary surgery.	Up to 2 days after 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.
Length of stay in hospital after surgery.	Up to 30 days after surgery.	Length of stay in hospital after surgery.

Trial Locations

Locations (1)

Peking University Hospital of Stomatology; 🇨🇳 Beijing, Haidian, China