NCT06045364

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2024

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

September 5, 2024

Status Verified

September 1, 2024

Enrollment Period

10 months

First QC Date

September 12, 2023

Last Update Submit

September 2, 2024

Conditions

Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

  • Incidence of postoperative nausea and vomiting

    Timepoint：24 hours after the ERCP

Study Arms (2)

Glycopyrrolate

EXPERIMENTAL

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

Drug: Glycopyrrolate

Anisodamine Group

ACTIVE COMPARATOR

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

Drug: Anisodamine

Interventions

GlycopyrrolateDRUG

During induction of anesthesia, 0.2mg Glycopyrrolate was given intravenously

Glycopyrrolate
AnisodamineDRUG

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

Anisodamine Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • : pregnancy
  • : glaucoma
  • : Myasthenia gravis
  • : Obstructive gastrointestinal diseases
  • : Obstructive urinary tract disease (prostatic hyperplasia)
  • : Heart disease (coronary heart disease, congestive heart failure)
  • : hyperthyroidism
  • : Previous history of abdominal or intestinal surgery
  • : Chronic renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital Of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

Location

MeSH Terms

Conditions

NauseaVomiting

Interventions

Glycopyrrolateanisodamine

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quaternary Ammonium CompoundsAminesOrganic ChemicalsOnium CompoundsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Guangyou Duan, doctor

    The Second Affiliated Hospital of Chongqing Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

September 12, 2023

First Posted

September 21, 2023

Study Start

October 1, 2023

Primary Completion

July 20, 2024

Study Completion

July 31, 2024

Last Updated

September 5, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)