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NCT06045364 Clinical Trial

Effect of Glycopyrrolate on Nausea and Vomiting After ERCP Operation

Nausea and Vomiting Clinical Trial

Official title:
Effect of Glycopyrrolate on Nausea and Vomiting After ERCP Operation

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06045364
Other study ID # 2023-115
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date October 1, 2023
Est. completion date August 1, 2024

Study information
Verified date March 2024
Source The Second Affiliated Hospital of Chongqing Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 130
Est. completion date August 1, 2024
Est. primary completion date July 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Glycopyrrolate
During induction of anesthesia, 0.2mg Glycopyrrolate was given intravenously
• Anisodamine
During induction of anesthesia,10mg of Anisodamine was given intramuscular injection.

Locations
Country Name City State
China The Second Affiliated Hospital Of Chongqing Medical University Chongqing Chongqing

Sponsors (1)
Lead Sponsor Collaborator
Jie Chen

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of postoperative nausea and vomiting Timepoint:24 hours after the ERCP
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