Effect of Glycopyrrolate on Nausea and Vomiting After ERCP Operation

Phase 1

Active, not recruiting

• Conditions: Nausea and Vomiting
• Interventions: Drug: Glycopyrrolate; Drug: Anisodamine

• Registration Number: NCT06045364
• Lead Sponsor: Jie Chen

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-09-12
• Study First Submitted QC: 2023-09-17
• Study First Posted: 2023-09-21
• Study Start: 2023-10-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-18
• Primary Completion: 2024-07-31
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glycopyrrolate	Glycopyrrolate	During induction of anesthesia, 0.2mg Glycopyrrolate was given intravenously to participants.
Anisodamine Group	Anisodamine	During induction of anesthesia,10mg of Anisodamine was given intramuscular injection

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative nausea and vomiting	Timepoint：24 hours after the ERCP

Trial Locations

Locations (1)

The Second Affiliated Hospital Of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China