Comparison of Postoperative Anti-nausea and Vomiting Effect Between Glycopyrronium and Ondansetron

Study Overview
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Brief Summary
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To compare the anti-nausea and vomiting effect between glycopyrronium and ondansetron for patients receiving elective surgery under general anesthesia. Based on this study the investigators intend to explore the feasibility of using glycopyrronium to prevent postoperative nausea and vomiting.

Official Title
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Comparison of Anti-nausea and Vomiting Effect After Elective Surgery Undergoing General Anesthesia Between Glycopyrronium and Ondansetron: a Multi-center Study

Conditions
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Postoperative Nausea and Vomiting

Intervention / Treatment
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* Drug: Glycopyrronium
* Drug: Ondansetron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists classification I-III Receive general anesthesia Voluntarily receive postoperative intravenous controlled analgesia Exclusion Criteria: Puerpera or lactation women Allergy or existing contraindication to glycopyrronium and ondansetron Participate in other clinical drug trials within three months Can not follow with the study procedure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glycopyrronium<br>Glycopyrronium (0.2mg) was intravenously given at the ending of the surgery. | Drug: Glycopyrronium<br>* Glycopyrronium (0.2mg) was intravenously given at the ending of the surgery.<br>|
| Active Comparator: Ondansetron<br>Ondansetron (4mg) was intravenously given at the ending of the surgery. | Drug: Ondansetron<br>* Glycopyrronium (4mg) was intravenously given at the ending of the surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of postoperative nausea and vomiting | postoperative nausea and vomiting is recorded according to follow-up visits after surgery | from the ending of surgery to 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intensity of postoperative nausea | intensity of postoperative nausea is assessed using Numeric Rating Scale (0-10, 0 represents no uncomfortable felling, 10 represents tolerableness) | from the ending of surgery to 24 hours after surgery | 
| incidence of postoperative vomiting | postoperative vomiting is recorded according to follow-up visits after surgery | from the ending of surgery to 24 hours after surgery | 
| incidence of intervention requirement for nausea and vomiting | this event is recorded according to follow-up visits after surgery | from the ending of surgery to 24 hours after surgery |