Status:
COMPLETED
Penehyclidine for Prevention of Nausea and Vomiting After Bimaxillary Surgery
Lead Sponsor:
Peking University First Hospital
Collaborating Sponsors:
Peking University Hospital of Stomatology
Conditions:
Penehyclidine
Postoperative Nausea and Vomiting
Eligibility:
All Genders
18-59 years
Phase:
NA
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 bimaxill...
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. Orthognathi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2021
Estimated Enrollment :
354 Patients enrolled
Trial Details
Trial ID
NCT04454866
Start Date
July 7 2020
End Date
April 15 2021
Last Update
September 16 2021
Active Locations (1)
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1
Peking Univeristy Hospital Stomatology
Beijing, China, 100081