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

NCT ID: NCT05331651

Last Updated: 2024-08-16

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-21

Study Completion Date

2023-06-30

Brief Summary

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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

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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 in Combination With Tropisetron

Group Type EXPERIMENTAL

Glycopyrronium in Combination With Tropisetron

Intervention Type DRUG

Glycopyrronium (0.2mg) in Combination With Tropisetron (4mg) intravenously given at the ending of the surgery.

Normal Saline in Combination With Tropisetron

Group Type PLACEBO_COMPARATOR

Normal Saline in Combination With Tropisetron

Intervention Type DRUG

Normal Saline in Combination With Tropisetron (4mg) intravenously given at the ending of the surgery.

Interventions

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Glycopyrronium in Combination With Tropisetron

Glycopyrronium (0.2mg) in Combination With Tropisetron (4mg) intravenously given at the ending of the surgery.

Intervention Type DRUG

Normal Saline in Combination With Tropisetron

Normal Saline in Combination With Tropisetron (4mg) intravenously given at the ending of the surgery.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chongqing General Hospital

OTHER

Sponsor Role collaborator

Chongqing Medical University

OTHER

Sponsor Role collaborator

The People's Hospital of DAZU ,Chongqing

UNKNOWN

Sponsor Role collaborator

The People's Hospital of Chongqing Kaizhou District

UNKNOWN

Sponsor Role collaborator

Fuling Hospital affiliated to Chongqing University

UNKNOWN

Sponsor Role collaborator

Qianjiang Central Hospital of Chongqing

UNKNOWN

Sponsor Role collaborator

Stomatological Hospital of Chongqing Medical University

UNKNOWN

Sponsor Role collaborator

People's Hospital of Changshou Chongqing

UNKNOWN

Sponsor Role collaborator

The Ninth People's Hospital of Chongqing

UNKNOWN

Sponsor Role collaborator

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

UNKNOWN

Sponsor Role collaborator

People's Hospital of Xiushan County

UNKNOWN

Sponsor Role collaborator

Wushan County People's Hospital

UNKNOWN

Sponsor Role collaborator

Three Gorges Hospital of Chongqing University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role collaborator

Department of Anesthesiology, Daping Hospital, Institute of Surgery Research, the Army Medical University

UNKNOWN

Sponsor Role collaborator

The People's Hospital of Nanchuan

UNKNOWN

Sponsor Role collaborator

Chongqing Traditional Chinese Medicine Hospital

OTHER

Sponsor Role collaborator

People's Hospital of Shapingba District, Chongqing

UNKNOWN

Sponsor Role collaborator

Chongqing Liangping District People's Hospital

UNKNOWN

Sponsor Role collaborator

Chongqing Jiangbei Hospital of Traditional Chinese Medicine

UNKNOWN

Sponsor Role collaborator

People's Hospital of Chongqing Hechuan

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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Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status

Countries

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China

References

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Chen J, Piao G, Luan G, Yu Y, Zheng W, Li Y, Zhang C, Duan Y, Zhao M, Zhang Y, Xiang W, Cheng L, Ji C, Duan G, Huang H. Effects of Glycopyrronium Bromide as an Adjuvant Treatment in the Prevention of Nausea and Vomiting After Abdominal, Thyroid, and Breast Surgery: A Multicenter Randomized Controlled Trial. Drug Des Devel Ther. 2025 Aug 19;19:7123-7134. doi: 10.2147/DDDT.S515670. eCollection 2025.

Reference Type DERIVED
PMID: 40859968 (View on PubMed)

Other Identifiers

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Glycopyrronium in anti-PONV

Identifier Type: -

Identifier Source: org_study_id

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