Effect of Glycopyrronium in Combination With Tropisetron in Anti-postoperative Nausea and Vomiting

Study Overview
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Brief Summary
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To compare the anti-nausea and vomiting effect between glycopyrronium in combination with tropisetron and normal saline in combination with tropisetron for patients receiving elective surgery under general anesthesia. Based on this study the investigators intend to explore the feasibility of using glycopyrronium as adjuvant drug to prevent postoperative nausea and vomiting.

Official Title
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Effect of Glycopyrronium in Combination With Tropisetron in Anti-postoperative Nausea and Vomiting

Conditions
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Postoperative Nausea and Vomiting

Intervention / Treatment
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* Drug: Glycopyrronium in Combination With Tropisetron
* Drug: Normal Saline in Combination With Tropisetron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-cardiac surgery 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 tropisetron 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 in Combination With Tropisetron<br> | Drug: Glycopyrronium in Combination With Tropisetron<br>* Glycopyrronium (0.2mg) in Combination With Tropisetron (4mg) intravenously given at the ending of the surgery.<br>|
| Placebo Comparator: Normal Saline in Combination With Tropisetron<br> | Drug: Normal Saline in Combination With Tropisetron<br>* Normal Saline in Combination With Tropisetron (4mg) 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 |