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

NCT ID: NCT05265507

Last Updated: 2023-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-21

Study Completion Date

2023-05-30

Brief Summary

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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

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Conditions

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Postoperative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Glycopyrronium

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

Group Type EXPERIMENTAL

Glycopyrronium

Intervention Type DRUG

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

Ondansetron

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

Group Type ACTIVE_COMPARATOR

Ondansetron

Intervention Type DRUG

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

Interventions

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Glycopyrronium

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

Intervention Type DRUG

Ondansetron

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chongqing University Jiangjin Hospital

UNKNOWN

Sponsor Role collaborator

Chongqing Medical University

OTHER

Sponsor Role collaborator

The People's Hospital of DAZU ,Chongqing

UNKNOWN

Sponsor Role collaborator

Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

West China Hospital

OTHER

Sponsor Role collaborator

The People's Hospital of Tongliang District, Chongqing city

UNKNOWN

Sponsor Role collaborator

Chongqing Medical Center for Women and Children

OTHER

Sponsor Role collaborator

Dianjiang People's Hospital of Chongqing

UNKNOWN

Sponsor Role collaborator

The Ninth People's Hospital of Chongqing

UNKNOWN

Sponsor Role collaborator

The People's Hospital of Yubei District of Chongqing city

UNKNOWN

Sponsor Role collaborator

Chongqing Yongchuan District People's Hospital

UNKNOWN

Sponsor Role collaborator

The First People's Hospital Of Chongqing Liang Jiang New Area

UNKNOWN

Sponsor Role collaborator

ChongGang General Hospital

UNKNOWN

Sponsor Role collaborator

The People's Hospital of Nanchuan

UNKNOWN

Sponsor Role collaborator

People's Hospital of Pengshui County

UNKNOWN

Sponsor Role collaborator

Yunyang people's Hospital

UNKNOWN

Sponsor Role collaborator

Chongqing Liangping District People's Hospital

UNKNOWN

Sponsor Role collaborator

Jiulongpo People's Hospital of chongqing

UNKNOWN

Sponsor Role collaborator

The People's Hospital of Qijiang District,Chongqing

UNKNOWN

Sponsor Role collaborator

University-Town Hospital of Chongqing Medical University

OTHER

Sponsor Role collaborator

Chongqing Public Health Medical Center

OTHER

Sponsor Role collaborator

CHONGQING BANAN HOSPITAL OF TCM

UNKNOWN

Sponsor Role collaborator

The Second Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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He Huang, MD

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital, Chongqing Medical University

Locations

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The Second Affiliated Hospital, Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Guangyou Duan, MD

Role: CONTACT

(+86)18323376014

Dagang Wang, MD

Role: CONTACT

+86 023 63693014

Facility Contacts

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Guangyou Duan, MD

Role: primary

(+86)18323376014

Other Identifiers

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Glycopyrronium and ondansetron

Identifier Type: -

Identifier Source: org_study_id

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