Clinical trial NCT04112771: Penehyclidine and Postoperative Nausea and Vomiting After Bimaxillary Surgery
Official title: Effects of Penehyclidine on Postoperative Nausea and Vomiting in Patients Underging Bimaxillary Surgery: A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Penehyclidine
Postoperative Nausea and Vomiting
Bimaxillar Surgery
Keywords: Penehyclidine
Postoperative nausea and vomiting
Bimaxillary surgery
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Peking University Hospital of Stomatology
First posted: 2019-10-02
Enrollment: 243
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients underwent bimaxillary surgery between April 1, 2018 and September 30, 2019 in Peking University Hospital of Stomatology.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Age \<16 years;
* Missing data.

Primary outcomes:
measure: Postoperative nausea and vomiting (PONV) within 48 hours after bimaxillary surgery.
timeFrame: Up to 48 hours after surgery.
Secondary outcomes:
measure: Daily prevalence of PONV.
timeFrame: Up to 48 hours after surgery.
measure: Postoperative agitation after bimaxillary surgery.
timeFrame: Up to 8:00 am on the first day after surgery.
measure: Postoperative pain after bimaxillary surgery.
timeFrame: Up to 2 days after surgery.
measure: Postoperative complications during hospital stay after surgery.
timeFrame: Up to 30 days after surgery.
measure: Length of stay in hospital after surgery.
timeFrame: Up to 30 days after surgery.
measure: In-hospital mortality after surgery.
timeFrame: Up to 30 days after surgery.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Hospital of Stomatology
state: Beijing
city: Beijing
country: China
facility: Peking University Hospital of Stomatology
state: Haidian
Study officials:
affiliation: Peking University First Hospital
name: Dong-Xin Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Myles PS, Williams DL, Hendrata M, Anderson H, Weeks AM. Patient satisfaction after anaesthesia and surgery: results of a prospective survey of 10,811 patients. Br J Anaesth. 2000 Jan;84(1):6-10. doi: 10.1093/oxfordjournals.bja.a013383.
citation: Naran S, Steinbacher DM, Taylor JA. Current Concepts in Orthognathic Surgery. Plast Reconstr Surg. 2018 Jun;141(6):925e-936e. doi: 10.1097/PRS.0000000000004438.
citation: Laskin DM, Carrico CK, Wood J. Predicting postoperative nausea and vomiting in patients undergoing oral and maxillofacial surgery. Int J Oral Maxillofac Surg. 2020 Jan;49(1):22-27. doi: 10.1016/j.ijom.2019.06.016. Epub 2019 Jun 21.
citation: Phillips C, Brookes CD, Rich J, Arbon J, Turvey TA. Postoperative nausea and vomiting following orthognathic surgery. Int J Oral Maxillofac Surg. 2015 Jun;44(6):745-51. doi: 10.1016/j.ijom.2015.01.006. Epub 2015 Feb 2.
citation: Dobbeleir M, De Coster J, Coucke W, Politis C. Postoperative nausea and vomiting after oral and maxillofacial surgery: a prospective study. Int J Oral Maxillofac Surg. 2018 Jun;47(6):721-725. doi: 10.1016/j.ijom.2017.11.018. Epub 2018 Jan 1.
citation: Shaikh SI, Nagarekha D, Hegade G, Marutheesh M. Postoperative nausea and vomiting: A simple yet complex problem. Anesth Essays Res. 2016 Sep-Dec;10(3):388-396. doi: 10.4103/0259-1162.179310.
citation: Han XY, Liu H, Liu CH, Wu B, Chen LF, Zhong BH, Liu KL. Synthesis of the optical isomers of a new anticholinergic drug, penehyclidine hydrochloride (8018). Bioorg Med Chem Lett. 2005 Apr 15;15(8):1979-82. doi: 10.1016/j.bmcl.2005.02.071.