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Effect of Glycopyrrolate on Nausea and Vomiting After ERCP Operation

Sponsor
Jie Chen (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06045364
Collaborator
(none)
130
Enrollment
2
Arms
10
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study aims to determine the role of Glycopyrrolate in preventing postoperative nausea and vomiting of ERCP.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
130 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Glycopyrrolate on Nausea and Vomiting After ERCP Operation
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Jul 31, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Incidence of postoperative nausea and vomiting [Timepoint：24 hours after the ERCP]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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 (arrhythmia, coronary heart disease, congestive heart failure)

8: hyperthyroidism

9: Previous history of abdominal or intestinal surgery

10: Chronic renal failure

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Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Jie Chen

Investigators

  • Study Director: Guangyou Duan, The Second Affiliated Hospital of Chongqing Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jie Chen, Clinical Professor, The Second Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier:
NCT06045364
Other Study ID Numbers:
  • 2023-115
First Posted:
Sep 21, 2023
Last Update Posted:
Sep 21, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Vomiting
Anisodamine
Glycopyrrolate

Study Results

No Results Posted as of Sep 21, 2023