Penehyclidine and Postoperative Nausea and Vomiting After Bimaxillary Surgery

Postoperative Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04112771
• Other study ID #: 201947098
• Status: Completed
• Start date: October 7, 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: June 2020
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Age =16 years;

• Underwent elective bimaxillary surgery under general anesthesia.

Exclusion Criteria:

• Age <16 years;

• Missing data.

Related Conditions & MeSH terms

• Bimaxillar Surgery
• Nausea
• Penehyclidine
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Penehyclidine hydrochloride
Penehyclidine hydrochloride was administered before anesthesia induction.

Other:
• No penehyclidine hydrochloride
Penehyclidine hydrochloride was not administered before anesthesia induction.

Locations

Country	Name	City	State
China	Peking University Hospital of Stomatology	Beijing	Beijing
China	Peking University Hospital of Stomatology	Beijing	Haidian

Sponsors (2)

Lead Sponsor	Collaborator
Peking University First Hospital	Peking University Hospital of Stomatology

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Length of stay in hospital after surgery.	Length of stay in hospital after surgery.	Up to 30 days after surgery.
Secondary	In-hospital mortality after surgery.	In-hospital mortality after surgery.	Up to 30 days after surgery.