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

Primary Purpose

Postoperative Nausea and Vomiting

Status

Recruiting

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Glycopyrronium

Ondansetron

About this trial

This is an interventional treatment trial for Postoperative Nausea and Vomiting

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The Second Affiliated Hospital, Chongqing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Glycopyrronium

Ondansetron

Arm Description

Glycopyrronium (0.2mg) was intravenously given at the ending of the surgery.

Ondansetron (4mg) was intravenously given at the ending of the surgery.

Outcomes

Primary Outcome Measures

incidence of postoperative nausea and vomiting

postoperative nausea and vomiting is recorded according to follow-up visits after surgery

Secondary Outcome Measures

intensity of postoperative nausea

intensity of postoperative nausea is assessed using Numeric Rating Scale (0-10, 0 represents no uncomfortable felling, 10 represents tolerableness)

incidence of postoperative vomiting

postoperative vomiting is recorded according to follow-up visits after surgery

incidence of intervention requirement for nausea and vomiting

this event is recorded according to follow-up visits after surgery

Full Information

NCT ID

NCT05265507

First Posted

February 23, 2022

Last Updated

February 22, 2023

Sponsor

The Second Affiliated Hospital of Chongqing Medical University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05265507

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

March 21, 2022 (Actual)

Primary Completion Date

May 30, 2023 (Anticipated)

Study Completion Date

May 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Second Affiliated Hospital of Chongqing Medical University

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Nausea and Vomiting

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Glycopyrronium

Arm Type

Experimental

Arm Description

Glycopyrronium (0.2mg) was intravenously given at the ending of the surgery.

Arm Title

Ondansetron

Arm Type

Active Comparator

Arm Description

Ondansetron (4mg) was intravenously given at the ending of the surgery.

Intervention Type

Drug

Intervention Name(s)

Glycopyrronium

Intervention Description

Glycopyrronium (0.2mg) was intravenously given at the ending of the surgery.

Intervention Type

Drug

Intervention Name(s)

Ondansetron

Intervention Description

Glycopyrronium (4mg) was intravenously given at the ending of the surgery.

Primary Outcome Measure Information:

Title

incidence of postoperative nausea and vomiting

Description

postoperative nausea and vomiting is recorded according to follow-up visits after surgery

Time Frame

from the ending of surgery to 24 hours after surgery

Secondary Outcome Measure Information:

Title

intensity of postoperative nausea

Description

intensity of postoperative nausea is assessed using Numeric Rating Scale (0-10, 0 represents no uncomfortable felling, 10 represents tolerableness)

Time Frame

from the ending of surgery to 24 hours after surgery

Title

incidence of postoperative vomiting

Description

postoperative vomiting is recorded according to follow-up visits after surgery

Time Frame

from the ending of surgery to 24 hours after surgery

Title

incidence of intervention requirement for nausea and vomiting

Description

this event is recorded according to follow-up visits after surgery

Time Frame

from the ending of surgery to 24 hours after surgery

Other Pre-specified Outcome Measures:

Title

Postoperative pain intensity

Description

Pain intensity is assessed by numerical rating scale (0-10, 0 represents painless; 10 represents intolerable pain)

Time Frame

from the ending of surgery to 24 hours after surgery

Title

Postoperative analgesic requirements

Description

Analgesic requirements is assessed by recording the volume of patient controlled analgesia pump

Time Frame

from the ending of surgery to 24 hours after surgery

Title

degree of satisfaction

Description

degree of satisfaction is assessed by patient using numerical rating scale (0-10, 0 represents unsatisfactory; 10 represents complete satisfaction)

Time Frame

from the ending of surgery to 24 hours after surgery

Title

adverse reaction related to glycopyrronium and ondansetron

Description

adverse reaction is recorded according to follow-up visits after surgery

Time Frame

from the ending of surgery to 24 hours after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Guangyou Duan, MD

Phone

(+86)18323376014

duangy@hospital.cqmu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Dagang Wang, MD

Phone

+86 023 63693014

kuanrenlunli@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

He Huang, MD

Organizational Affiliation

The Second Affiliated Hospital, Chongqing Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Second Affiliated Hospital, Chongqing Medical University

City

Chongqing

State/Province

Chongqing

ZIP/Postal Code

400010

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Guangyou Duan, MD

Phone

(+86)18323376014

duangy@hospital.cqmu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Learn more about this trial

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

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