Clinical trial NCT04454866: Penehyclidine for Prevention of Nausea and Vomiting After Bimaxillary Surgery
Official title: Effects of Penehyclidine in Preventing Postoperative Nausea and Vomiting in Patients Underging Bimaxillary Surgery: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Penehyclidine
Postoperative Nausea and Vomiting
Bimaxillar Surgery
Keywords: Penehyclidine
Postoperative Nausea and Vomiting
Bimaxillar Surgery
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Peking University Hospital of Stomatology
First posted: 2020-07-02
Enrollment: 354
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Incidence of nausea and vomiting within 72 hours after bimaxillary surgery.
timeFrame: Up to 72 hours after surgery.
Secondary outcomes:
measure: Incidence of nausea and vomiting at different stages after bimaxillary surgery.
timeFrame: Up to 72 hours after surgery.
measure: Incidence of moderate to severe nausea at different stages after bimaxillary surgery.
timeFrame: Up to 72 hours after surgery.
measure: Incidence of moderate to severe nausea within 72 hours after bimaxillary surgery.
timeFrame: Up to 72 hours after surgery.
measure: Severity of nausea and vomiting within 72 hours after bimaxillary surgery.
timeFrame: Up to 72 hours after surgery.
measure: Use of rescue antiemetics within 72 hours after bimaxillary surgery.
timeFrame: Up to 72 hours after surgery.
measure: Incidence of delirium within the first 5 days after surgery
timeFrame: Up to 5 days after surgery.
measure: Length of stay in hospital after surgery.
timeFrame: Up to 30 days after surgery.
measure: Incidence of complications within 30 days after surgery.
timeFrame: Up to 30 days after surgery.
measure: All-cause 30-day mortality.
timeFrame: Within 30 days after surgery.
measure: Cognitive function on the 30th day after surgery.
timeFrame: At 30 days after surgery
Other outcomes:
measure: Incidence of moderate to severe pain at different stages after bimaxillary surgery.
timeFrame: Up to 72 hours after surgery.
measure: Use of rescue analgesics within 72 hours after bimaxillary surgery.
timeFrame: Up to 72 hours after surgery.
measure: Subjective sleep quality within 3 days after bimaxillary surgery.
timeFrame: In the morning of the 1st, 2nd, and 3rd days after surgery.
Locations:
city: Beijing
country: China
facility: Peking Univeristy Hospital Stomatology
Study officials:
affiliation: Peking University First Hospital
name: Dong-Xin Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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citation: 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.