Penehyclidine and Postoperative Nausea and Vomiting After Bimaxillary Surgery

NCT04112771 | Completed

• 1 other identifier: 201947098
• Study Type: observational
• Target: 243
• Locations: 1 country
• Sites: 2

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.

Conditions

Penehyclidine; Postoperative Nausea and Vomiting; Bimaxillar Surgery

Keywords

Penehyclidine; Postoperative nausea and vomiting; Bimaxillary surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Daily prevalence of PONV.

  Up to 48 hours after surgery.

• Postoperative agitation after bimaxillary surgery.

  Up to 8:00 am on the first day after surgery.

• Postoperative pain after bimaxillary surgery.

  Up to 2 days after surgery.

• Postoperative complications during hospital stay after surgery.

  Up to 30 days after surgery.

• Length of stay in hospital after surgery.

  Up to 30 days after surgery.

Study Arms (2)

Penehyclidine group

Penehyclindine hydrochloride was administered before anesthesia induction.

Drug: Penehyclidine hydrochloride

Placebo group

Penehyclindine hydrochloride was not administered before anesthesia induction.

Other: No penehyclidine hydrochloride

Interventions

Penehyclidine hydrochloride DRUG

Penehyclidine hydrochloride was administered before anesthesia induction.

Penehyclidine group

No penehyclidine hydrochloride OTHER

Penehyclidine hydrochloride was not administered before anesthesia induction.

Placebo group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Age \<16 years;
• Missing data.

Sponsors & Collaborators

• Peking University First Hospital: lead
• Peking University Hospital of Stomatology: collaborator

Study Sites (2)

Peking University Hospital of Stomatology

Beijing, Beijing Municipality, 100081, China

Location

Peking University Hospital of Stomatology

Beijing, Haidian, 100081, China

Location

Related Publications (7)

• 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.

  PMID: 10740539 BACKGROUND

• 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.

  PMID: 29794714 BACKGROUND

• 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.

  PMID: 31230771 BACKGROUND

• 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.

  PMID: 25655765 BACKGROUND

• 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.

  PMID: 29301675 BACKGROUND

• 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.

  PMID: 27746521 BACKGROUND

• 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.

  PMID: 15808451 BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

penehyclidine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Department of Anaesthesiology and Critical Care Medicine

Study Record Dates

• First Submitted: September 27, 2019
• First Posted: October 2, 2019
• Study Start: October 7, 2019
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: June 30, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)