Effect of Glycopyrrolate on Nausea and Vomiting After ERCP Operation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT05331651

Postoperative Nausea and Vomiting

COMPLETED PHASE4

Comparison of Postoperative Anti-nausea and Vomiting Effect Between Glycopyrronium and Ondansetron

NCT05265507

Postoperative Nausea and Vomiting

UNKNOWN PHASE4

An Economic Study of HSK21542 Injection for Prevention of Postoperative Nausea and Vomiting

NCT06359535

Nausea and Vomiting, Postoperative

RECRUITING PHASE4

Tablet Ginger Versus Tablet Doxylamine Succinate in Control of Nausea and Vomiting in Pregnancy

NCT06772974

Nausea Gravidarum Hyperemesis Gravidarum

NOT_YET_RECRUITING NA

Usefulness of Metoclopramide to Improve Endoscopic Visualization in Upper Gastrointestinal Bleeding

NCT06297954

Upper Gastrointestinal Bleeding

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nausea and Vomiting

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Glycopyrrolate

During induction of anesthesia, 0.2mg Glycopyrrolate was given intravenously to participants.

Group Type EXPERIMENTAL

Glycopyrrolate

Intervention Type DRUG

During induction of anesthesia, 0.2mg Glycopyrrolate was given intravenously

Anisodamine Group

During induction of anesthesia,10mg of Anisodamine was given intramuscular injection

Group Type ACTIVE_COMPARATOR

Anisodamine

Intervention Type DRUG

During induction of anesthesia,10mg of Anisodamine was given intramuscular injection.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Glycopyrrolate

During induction of anesthesia, 0.2mg Glycopyrrolate was given intravenously

Intervention Type DRUG

Anisodamine

During induction of anesthesia,10mg of Anisodamine was given intramuscular injection.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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

\-

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes