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

Phase 4

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Drug: Glycopyrronium; Drug: Ondansetron

• Registration Number: NCT05265507
• Lead Sponsor: The Second Affiliated Hospital of Chongqing Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-23
• Study First Submitted QC: 2022-02-23
• Status Verified: 2022-03
• Study First Posted: 2022-03-03
• Study Start: 2022-03-21
• Last Update Submitted: 2023-02-22
• Last Update Posted: 2023-02-24
• Primary Completion: 2023-05-30
• Study Completion: 2023-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 480

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glycopyrronium	Glycopyrronium	Glycopyrronium (0.2mg) was intravenously given at the ending of the surgery.
Ondansetron	Ondansetron	Ondansetron (4mg) was intravenously given at the ending of the surgery.

Primary Outcome Measures

Name	Time	Method
incidence of postoperative nausea and vomiting	from the ending of surgery to 24 hours after surgery	postoperative nausea and vomiting is recorded according to follow-up visits after surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Second Affiliated Hospital, Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China