Penehyclidine for Prevention of Nausea and Vomiting After Bimaxillary Surgery

NCT04454866 | Completed

• 1 other identifier: 202055076
• Study Type: interventional
• Target: 354
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative nausea and vomiting (PONV) is a common complication 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 investigators hypothesize that continuously administrated penehyclidine during perioperative period can reduce the incidence of PONV in patients undergoing bimaxillary surgery.

Conditions

Penehyclidine; Postoperative Nausea and Vomiting; Bimaxillar Surgery

Keywords

Penehyclidine; Postoperative Nausea and Vomiting; Bimaxillar Surgery

Outcome Measures

Primary Outcomes (1)

• Incidence of nausea and vomiting within 72 hours after bimaxillary surgery.

  Nausea was assessed by direct questioning. Vomiting was diagnosed when patients retched or expulsed intra-gastric contents.

  Up to 72 hours after surgery.

Secondary Outcomes (10)

• Incidence of nausea and vomiting at different stages after bimaxillary surgery.

  Up to 72 hours after surgery.

• Incidence of moderate to severe nausea at different stages after bimaxillary surgery.

  Up to 72 hours after surgery.

• Incidence of moderate to severe nausea within 72 hours after bimaxillary surgery.

  Up to 72 hours after surgery.

• Severity of nausea and vomiting within 72 hours after bimaxillary surgery.

  Up to 72 hours after surgery.

• Use of rescue antiemetics within 72 hours after bimaxillary surgery.

  Up to 72 hours after surgery.

Other Outcomes (3)

• Incidence of moderate to severe pain at different stages after bimaxillary surgery.

  Up to 72 hours after surgery.

• Use of rescue analgesics within 72 hours after bimaxillary surgery.

  Up to 72 hours after surgery.

• Subjective sleep quality within 3 days after bimaxillary surgery.

  In the morning of the 1st, 2nd, and 3rd days after surgery.

Study Arms (3)

Control group

PLACEBO COMPARATOR

For patients in the control group, a dose of placebo (normal saline 5 ml) is injected intravenously before anesthesia induction. A patient-controlled intravenous analgesia pump is provided after surgery, which is established with a mixture of placebo (normal saline 5 ml), sufentanil (1.25-1.5 ug/kg) and tropisetron 10 mg, diluted with normal saline to 100 ml, and programmed to administer a continuous infusion at a rate of 2 ml/h for 48 hours.

Drug: Placebo

Single injection group

EXPERIMENTAL

For patients in this group, a dose of penehyclidine (0.5 mg/5 ml) is injected intravenously before anesthesia induction. A patient-controlled intravenous analgesia pump is provided after surgery, which is established with a mixture of placebo (normal saline 5 ml), sufentanil (1.25-1.5 ug/kg) and tropisetron (10 mg), diluted with normal saline to 100 ml, and programmed to administer a continuous infusion at a rate of 2 ml/h for 48 hours.

Drug: Single injection of penehyclidine

Continuous infusion group

EXPERIMENTAL

For patients in this group, a dose of penehyclidine (0.25 mg/5 ml) is injected intravenously before anesthesia induction. A patient-controlled intravenous analgesia pump is provided after surgery, which is established with a mixture of penehyclidine (0.25 mg/5 ml), sufentanil (1.25-1.5 ug/kg) and tropisetron (10 mg), diluted with normal saline to 100 ml, and programmed to administer a continuous infusion at a rate of 2 ml/h for 48 hours.

Drug: Continuous infusion of penehyclidine

Interventions

Single injection of penehyclidine DRUG

A dose of penehyclidine hydrochloride (0.5 mg/5 ml) is injected intravenously before anesthesia induction. A patient-controlled intravenous analgesia pump is provided after surgery, which is established with a mixture of placebo (normal saline 5 ml), sufentanil (1.25-1.5 ug/kg) and tropisetron (10 mg), diluted with normal saline to 100 ml, and programmed to administer a continuous infusion at a rate of 2 ml/h for 48 hours.

Also known as: Penehyclidine hydrochloride

Single injection group

Continuous infusion of penehyclidine DRUG

A dose of penehyclidine hydrochloride (0.25 mg/5 ml) is injected intravenously before anesthesia induction. A patient-controlled intravenous analgesia pump is provided after surgery, which is established with a mixture of penehyclidine hydrochloride (0.25 mg/5 ml), sufentanil (1.25-1.5 ug/kg) and tropisetron (10 mg), diluted with normal saline to 100 ml, and programmed to administer a continuous infusion at a rate of 2 ml/h for 48 hours.

Also known as: Penehyclidine hydrochloride

Continuous infusion group

Placebo DRUG

A dose of placebo (normal saline 5 ml) is injected intravenously before anesthesia induction. A patient-controlled intravenous analgesia pump is provided after surgery, which is established with a mixture of placebo (normal saline 5 ml), sufentanil (1.25-1.5 ug/kg) and tropisetron (10 mg), diluted with normal saline to 100 ml, and programmed to administer a continuous infusion at a rate of 2 ml/h for 48 hours.

Also known as: Normal saline

Control group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥18 years but \<60 years; body mass index ≥18 but \<30 kg/m2;
• Scheduled to undergo elective bimaxillary surgery under general anesthesia;
• Planned to use patient-controlled intravenous analgesia (PCIA) after surgery;
• Provide written informed consents.

You may not qualify if:

• Presence of glaucoma;
• Allergic to penehyclidine, atropine, scopolamine or other anticholinergic drugs;
• Acute or chronic nausea and/or vomiting, or gastrointestinal motility disorders before surgery;
• Preoperative antiemetic therapy within 12 hours;
• History of schizophrenia, Parkinson's disease or profound dementia, or language barrier;
• Severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (requirement of renal replacement therapy before surgery) or American Society of Anesthesiologists physical status ≥IV.

Sponsors & Collaborators

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

Study Sites (1)

Peking Univeristy Hospital Stomatology

Beijing, 100081, China

Location

Related Publications (9)

• 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

• Zhang Z, Zhuang Y, Ouyang F, Zhang A, Zeng B, Gu M. Penehyclidine enhances the efficacy of tropisetron in prevention of PONV following gynecological laparoscopic surgery. J Anesth. 2012 Dec;26(6):864-9. doi: 10.1007/s00540-012-1443-1. Epub 2012 Aug 10.

  PMID: 22878869 BACKGROUND

• Wang LK, Cheng T, Yang XD, Xiong GL, Li N, Wang DX. Penehyclidine for prevention of postoperative nausea and vomiting following bimaxillary orthognathic surgery: a randomized, double-blind, controlled trial. J Anesth. 2022 Feb;36(1):122-136. doi: 10.1007/s00540-021-03017-4. Epub 2021 Nov 5.

  PMID: 34738161 DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

penehyclidine; Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Department of Anaesthesiology and Critical Care Medicine

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 2, 2020
• Study Start: July 7, 2020
• Primary Completion: March 15, 2021
• Study Completion: April 15, 2021
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)