Penehyclidine for Prevention of Nausea and Vomiting After Bimaxillary Surgery

NCT ID: NCT04454866

Last Updated: 2021-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 354 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-07
• Study Completion Date: 2021-04-15

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.

Detailed Description

Postoperative nausea and vomiting (PONV) is one of the most frequently occurred complications after surgery, and are associated with patients' dissatisfaction after anesthesia and surgery. Orthognathic surgery is widely performed for the correction of dentofacial deformities. 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. Our previous study indicated that single-dose of penehyclidine injected before anesthesia induction was associated with a reduced risk of PONV during the first 6 h postoperatively.The mean elimination half-life of penehyclidine following single administration is about 10.35 h. Hence, a single-dose penehyclidine may only produce a short duration of antiemetic effect.

The investigators hypothesize that continuously administrated penehyclidine during perioperative period reduces PONV more effectively than single-dose injection in patients undergoing bimaxillary surgery. The purpose of this study is to investigate the effect of continuous administered penehyclidine in preventing PONV in patients undergoing bimaxillary surgery.

Conditions

Penehyclidine; Postoperative Nausea and Vomiting; Bimaxillar Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Control group

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Single injection group

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.

Group Type: EXPERIMENTAL

Single injection of penehyclidine

Intervention Type: 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.

Continuous infusion group

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.

Group Type: EXPERIMENTAL

Continuous infusion of penehyclidine

Intervention Type: 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.

Interventions

Single injection of penehyclidine

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.

Intervention Type: DRUG

Continuous infusion of penehyclidine

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.

Intervention Type: DRUG

Placebo

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.

Intervention Type: DRUG

Other Intervention Names

Penehyclidine hydrochloride; Penehyclidine hydrochloride; Normal saline

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 years but <60 years; body mass index ≥18 but <30 kg/m2;

2. Scheduled to undergo elective bimaxillary surgery under general anesthesia;

3. Planned to use patient-controlled intravenous analgesia (PCIA) after surgery;

4. Provide written informed consents.

Exclusion Criteria

1. Presence of glaucoma;

2. Allergic to penehyclidine, atropine, scopolamine or other anticholinergic drugs;

3. Acute or chronic nausea and/or vomiting, or gastrointestinal motility disorders before surgery;

4. Preoperative antiemetic therapy within 12 hours;

5. History of schizophrenia, Parkinson's disease or profound dementia, or language barrier;

6. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 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 Univeristy Hospital Stomatology

Beijing, , China

Countries

China

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: DERIVED

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Other Identifiers

202055076

Identifier Type: -

Identifier Source: org_study_id