Effect of Glycopyrrolate on Nausea and Vomiting After ERCP Operation

September 2, 2024 updated by: Jie Chen
This study aims to determine the role of Glycopyrrolate in preventing postoperative nausea and vomiting of ERCP.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective, double-blind, randomized controlled trial. Patients who meet the criteria of our center and need to undergo ERCP lesion resection will be included and randomly divided into groups. After receiving Glycopyrrolate (experimental group) and Anisodamine (control group), duodenal peristalsis, biliary and pancreatic treatment time and postoperative nausea and vomiting will be observed during therapeutic ERCP. The inhibitory effect of Glycopyrrolate on postoperative nausea and vomiting of ERCP will be analyzed statistically.

Main outcome measure: incidence of nausea and vomiting after ERCP Secondary outcome measures: mean duodenal contractions per minute, duodenal spasm frequency and score, ERCP operation time, occurrence of other side effects of medication, remedial medication, and incidence of adverse events

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

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

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400000
        • The Second Affiliated Hospital of 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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 1.Adults 18-80 years old 2.ASA :I-III 3.Patients who are able to give informed consent and are currently planning to have the lesion removed or examined at the descending ERCP

Exclusion Criteria:1: Use of anticholinergic drugs

2: pregnancy

3: glaucoma

4: Myasthenia gravis

5: Obstructive gastrointestinal diseases

6: Obstructive urinary tract disease (prostatic hyperplasia)

7: Heart disease (coronary heart disease, congestive heart failure)

8: hyperthyroidism

9: Previous history of abdominal or intestinal surgery

10: Chronic renal failure

-

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
Intervention / Treatment
Experimental: Glycopyrrolate
During induction of anesthesia, 0.2mg Glycopyrrolate was given intravenously to participants.
Drug: Glycopyrrolate
During induction of anesthesia, 0.2mg Glycopyrrolate was given intravenously
Active Comparator: Anisodamine Group
During induction of anesthesia,10mg of Anisodamine was given intramuscular injection
Drug: Anisodamine
During induction of anesthesia,10mg of Anisodamine was given intramuscular injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of postoperative nausea and vomiting
Time Frame: Timepoint：24 hours after the ERCP
Timepoint：24 hours after the ERCP

Collaborators and Investigators

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

Sponsor

Jie Chen

Investigators

  • Study Director: Guangyou Duan, doctor, The Second Affiliated Hospital of 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)

October 1, 2023

Primary Completion (Actual)

July 20, 2024

Study Completion (Actual)

July 31, 2024

Study Registration Dates

First Submitted

September 12, 2023

First Submitted That Met QC Criteria

September 17, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Estimated)

September 5, 2024

Last Update Submitted That Met QC Criteria

September 2, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-115

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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