NCT05331651

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 15, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

April 21, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

August 16, 2024

Status Verified

December 1, 2022

Enrollment Period

1.2 years

First QC Date

April 11, 2022

Last Update Submit

August 14, 2024

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • intensity of postoperative nausea

    from the ending of surgery to 24 hours after surgery

  • incidence of postoperative vomiting

    from the ending of surgery to 24 hours after surgery

  • incidence of intervention requirement for nausea and vomiting

    from the ending of surgery to 24 hours after surgery

Other Outcomes (4)

  • Postoperative pain intensity

    from the ending of surgery to 24 hours after surgery

  • Postoperative analgesic requirements

    from the ending of surgery to 24 hours after surgery

  • degree of satisfaction

    from the ending of surgery to 24 hours after surgery

  • +1 more other outcomes

Study Arms (2)

Glycopyrronium in Combination With Tropisetron

EXPERIMENTAL
Drug: Glycopyrronium in Combination With Tropisetron

Normal Saline in Combination With Tropisetron

PLACEBO COMPARATOR
Drug: Normal Saline in Combination With Tropisetron

Interventions

Glycopyrronium in Combination With TropisetronDRUG

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

Glycopyrronium in Combination With Tropisetron
Normal Saline in Combination With TropisetronDRUG

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

Normal Saline in Combination With Tropisetron

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-cardiac surgery
  • American Society of Anesthesiologists classification I-III
  • Receive general anesthesia
  • Voluntarily receive postoperative intravenous controlled analgesia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Chongqing, Chongqing Municipality, 400010, China

Location

Related Publications (1)

  • 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.

    PMID: 40859968DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

GlycopyrrolateTropisetronSaline Solution

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Intervention Hierarchy (Ancestors)

Quaternary Ammonium CompoundsAminesOrganic ChemicalsOnium CompoundsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • He Huang, MD

    The Second Affiliated Hospital, Chongqing Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2022

First Posted

April 15, 2022

Study Start

April 21, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

August 16, 2024

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will share

The individual participant data for this study is available from the sponsor on reasonable request through email.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Within five years

Locations

CN(1)