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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Nausea and Vomiting
• Intervention / Treatment: Drug: Glycopyrronium; Drug: Ondansetron

• Study Type: Interventional
• Enrollment (Anticipated): 480
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Guangyou Duan, MD; Phone Number: (+86)18323376014; Email: duangy@hospital.cqmu.edu.cn

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400010
      • Recruiting
      • The Second Affiliated Hospital, Chongqing Medical University
      • Contact: Guangyou Duan, MD; Phone Number: (+86)18323376014; Email: duangy@hospital.cqmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Glycopyrronium; Glycopyrronium (0.2mg) was intravenously given at the ending of the surgery.	Drug: 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.	Drug: Ondansetron; Glycopyrronium (4mg) was intravenously given at the ending of the surgery.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain intensity	Pain intensity is assessed by numerical rating scale (0-10, 0 represents painless; 10 represents intolerable pain)	from the ending of surgery to 24 hours after surgery
Postoperative analgesic requirements	Analgesic requirements is assessed by recording the volume of patient controlled analgesia pump	from the ending of surgery to 24 hours after surgery
degree of satisfaction	degree of satisfaction is assessed by patient using numerical rating scale (0-10, 0 represents unsatisfactory; 10 represents complete satisfaction)	from the ending of surgery to 24 hours after surgery
adverse reaction related to glycopyrronium and ondansetron	adverse reaction is recorded according to follow-up visits after surgery	from the ending of surgery to 24 hours after surgery

Collaborators and Investigators

• Sponsor: The Second Affiliated Hospital of Chongqing Medical University
• Collaborators: Xiangya Hospital of Central South University; West China Hospital; Chongqing Medical University; Chongqing Medical Center for Women and Children; The People's Hospital of DAZU ，Chongqing; The Ninth People's Hospital of Chongqing; The First People's Hospital Of Chongqing Liang Jiang New Area; The People's Hospital of Nanchuan; Chongqing Liangping District People's Hospital; University-Town Hospital of Chongqing Medical University; Chongqing Public Health Medical Center; Chongqing University Jiangjin Hospital; The People's Hospital of Tongliang District， Chongqing city; Dianjiang People's Hospital of Chongqing; The People's Hospital of Yubei District of Chongqing city; Chongqing Yongchuan District People's Hospital; ChongGang General Hospital; People's Hospital of Pengshui County; Yunyang people's Hospital; Jiulongpo People's Hospital of chongqing; The People's Hospital of Qijiang District，Chongqing; CHONGQING BANAN HOSPITAL OF TCM
• Investigators: Principal Investigator: He Huang, MD, The Second Affiliated Hospital, Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2022
• Primary Completion (Anticipated): May 30, 2023
• Study Completion (Anticipated): May 30, 2023

Study Registration Dates

• First Submitted: February 23, 2022
• First Submitted That Met QC Criteria: February 23, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Antagonists; Adjuvants, Anesthesia; Anti-Anxiety Agents; Antipruritics; Glycopyrrolate; Ondansetron
• Other Study ID Numbers: Glycopyrronium and ondansetron

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The individual participant data for this study is available from the sponsor on reasonable request through email.
• IPD Sharing Time Frame: Within five years
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No