Penehyclidine and Postoperative Nausea and Vomiting After Bimaxillary Surgery

NCT ID: NCT04112771

Last Updated: 2020-06-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 243 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-07
• Study Completion Date: 2019-12-30

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.

Conditions

Penehyclidine; Postoperative Nausea and Vomiting; Bimaxillar Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Penehyclidine group

Penehyclindine hydrochloride was administered before anesthesia induction.

Penehyclidine hydrochloride

Intervention Type: DRUG

Penehyclidine hydrochloride was administered before anesthesia induction.

Placebo group

Penehyclindine hydrochloride was not administered before anesthesia induction.

No penehyclidine hydrochloride

Intervention Type: OTHER

Penehyclidine hydrochloride was not administered before anesthesia induction.

Interventions

Penehyclidine hydrochloride

Penehyclidine hydrochloride was administered before anesthesia induction.

Intervention Type: DRUG

No penehyclidine hydrochloride

Penehyclidine hydrochloride was not administered before anesthesia induction.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Age <16 years;
• Missing data.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Hospital of Stomatology

OTHER

Sponsor Role: collaborator

Peking University First Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dong-Xin Wang

Professor and Chairman, Department of Anaesthesiology and Critical Care Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dong-Xin Wang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Locations

Peking University Hospital of Stomatology

Beijing, Beijing Municipality, China

Peking University Hospital of Stomatology

Beijing, Haidian, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 10740539 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29794714 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31230771 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25655765 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29301675 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27746521 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15808451 (View on PubMed)

Other Identifiers

201947098

Identifier Type: -

Identifier Source: org_study_id