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Penehyclidine and Postoperative Nausea and Vomiting After Bimaxillary Surgery

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04112771
Enrollment
243
Registered
2019-10-02
Start date
2019-10-07
Completion date
2019-12-30
Last updated
2020-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bimaxillar Surgery, Penehyclidine, Postoperative Nausea and Vomiting

Keywords

Penehyclidine, Postoperative nausea and vomiting, Bimaxillary surgery

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.

Interventions

Penehyclidine hydrochloride was administered before anesthesia induction.

OTHERNo penehyclidine hydrochloride

Penehyclidine hydrochloride was not administered before anesthesia induction.

Sponsors

Peking University Hospital of Stomatology
CollaboratorOTHER
Peking University First Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Age \<16 years; * Missing data.

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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 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.
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.
Length of stay in hospital after surgery.Up to 30 days after surgery.Length of stay in hospital after surgery.
In-hospital mortality after surgery.Up to 30 days after surgery.In-hospital mortality after surgery.
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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026