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

August 14, 2024 updated by: The Second Affiliated Hospital of Chongqing Medical University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
480

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400010
        • Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Glycopyrronium in Combination With Tropisetron
Drug: Glycopyrronium in Combination With Tropisetron
Glycopyrronium (0.2mg) in Combination With Tropisetron (4mg) intravenously given at the ending of the surgery.
Placebo Comparator: Normal Saline in Combination With Tropisetron
Drug: Normal Saline in Combination With Tropisetron
Normal Saline in Combination With Tropisetron (4mg) intravenously given at the ending of the surgery.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
incidence of postoperative nausea and vomiting
Time Frame: from the ending of surgery to 24 hours after surgery
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
intensity of postoperative nausea
Time Frame: from the ending of surgery to 24 hours after surgery
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
Time Frame: from the ending of surgery to 24 hours after surgery
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
Time Frame: from the ending of surgery to 24 hours after surgery
this event is recorded according to follow-up visits after surgery
from the ending of surgery to 24 hours after surgery

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postoperative pain intensity
Time Frame: from the ending of surgery to 24 hours after surgery
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
Time Frame: from the ending of surgery to 24 hours after surgery
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
Time Frame: from the ending of surgery to 24 hours after surgery
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
Time Frame: from the ending of surgery to 24 hours after surgery
adverse reaction is recorded according to follow-up visits after surgery
from the ending of surgery to 24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Second Affiliated Hospital of Chongqing Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Chongqing Medical University
First Affiliated Hospital of Chongqing Medical University
Chongqing Traditional Chinese Medicine Hospital
Chongqing General Hospital
The People's Hospital of DAZU ，Chongqing
The People's Hospital of Chongqing Kaizhou District
Fuling Hospital affiliated to Chongqing University
Qianjiang Central Hospital of Chongqing
Stomatological Hospital of Chongqing Medical University
People's Hospital of Changshou Chongqing
The Ninth People's Hospital of Chongqing
The First People's Hospital Of Chongqing Liang Jiang New Area
People's Hospital of Xiushan County
Wushan County People's Hospital
Department of Anesthesiology, Daping Hospital, Institute of Surgery Research, the Army Medical University
The People's Hospital of Nanchuan
People's Hospital of Shapingba District， Chongqing
Chongqing Liangping District People's Hospital
Chongqing Jiangbei Hospital of Traditional Chinese Medicine
People's Hospital of Chongqing Hechuan
Three Gorges Hospital of Chongqing University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: He Huang, MD, The Second Affiliated Hospital, Chongqing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 21, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 15, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Glycopyrronium in anti-PONV

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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