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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 30, 2023

Interventions

  • Drug: Glycopyrronium
    • Glycopyrronium (0.2mg) was intravenously given at the ending of the surgery.
  • Drug: Ondansetron
    • Glycopyrronium (4mg) was intravenously given at the ending of the surgery.

Arms, Groups and Cohorts

  • Experimental: Glycopyrronium
    • Glycopyrronium (0.2mg) was intravenously given at the ending of the surgery.
  • Active Comparator: Ondansetron
    • Ondansetron (4mg) was intravenously given at the ending of the surgery.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • intensity of postoperative nausea
    • Time Frame: 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
    • Time Frame: from the ending of surgery to 24 hours after surgery
    • postoperative vomiting is recorded according to follow-up visits after surgery
  • incidence of intervention requirement for nausea and vomiting
    • Time Frame: from the ending of surgery to 24 hours after surgery
    • this event is recorded according to follow-up visits after surgery

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The Second Affiliated Hospital of Chongqing Medical University
  • Collaborator
    • Chongqing University Jiangjin Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • He Huang, MD, Principal Investigator, The Second Affiliated Hospital, Chongqing Medical University
  • Overall Contact(s)
    • Guangyou Duan, MD, (+86)18323376014, duangy@hospital.cqmu.edu.cn

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