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

Phase 4

Completed

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Drug: Glycopyrronium in Combination With Tropisetron; Drug: Normal Saline in Combination With Tropisetron

• Registration Number: NCT05331651
• Lead Sponsor: The Second Affiliated Hospital of Chongqing Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-11
• Study First Submitted QC: 2022-04-11
• Study First Posted: 2022-04-15
• Study Start: 2022-04-21
• Status Verified: 2022-12
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Last Update Submitted: 2024-08-14
• Last Update Posted: 2024-08-16

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glycopyrronium in Combination With Tropisetron	Glycopyrronium in Combination With Tropisetron	-
Normal Saline in Combination With Tropisetron	Normal Saline in Combination With Tropisetron	-

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
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)
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

Trial Locations

Locations (1)

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