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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Nausea and Vomiting; Penehyclidine; Bimaxillar Surgery
• Intervention / Treatment: Drug: Penehyclidine hydrochloride; Other: No penehyclidine hydrochloride

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 Type: Observational
• Enrollment (Actual): 243

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100081
      • Peking University Hospital of Stomatology
  • Haidian
    • Beijing, Haidian, China, 100081
      • Peking University Hospital of Stomatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients underwent bimaxillary surgery between April 1, 2018 and September 30, 2019 in Peking University Hospital of Stomatology.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Age <16 years;
• Missing data.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Penehyclidine group; Penehyclindine hydrochloride was administered before anesthesia induction.	Drug: Penehyclidine hydrochloride; Penehyclidine hydrochloride was administered before anesthesia induction.
Placebo group; Penehyclindine hydrochloride was not administered before anesthesia induction.	Other: No penehyclidine hydrochloride; Penehyclidine hydrochloride was not administered before anesthesia induction.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Peking University First Hospital
• Collaborators: Peking University Hospital of Stomatology

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2019
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: September 27, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (Actual): October 2, 2019

Study Record Updates

• Last Update Posted (Actual): June 30, 2020
• Last Update Submitted That Met QC Criteria: June 26, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Penehyclidine; Postoperative nausea and vomiting; Bimaxillary surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting
• Other Study ID Numbers: 201947098

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No