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Effect of Glycopyrrolate on Nausea and Vomiting After ERCP Operation

Primary Purpose

PIK3CA E545A

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Glycopyrrolate
Anisodamine
Sponsored by
Jie Chen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PIK3CA E545A

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Glycopyrrolate

    Anisodamine Group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Incidence of postoperative nausea and vomiting

    Secondary Outcome Measures

    Full Information

    First Posted
    September 12, 2023
    Last Updated
    September 17, 2023
    Sponsor
    Jie Chen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06045364
    Brief Title
    Effect of Glycopyrrolate on Nausea and Vomiting After ERCP Operation
    Official Title
    Effect of Glycopyrrolate on Nausea and Vomiting After ERCP Operation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    July 31, 2024 (Anticipated)
    Study Completion Date
    August 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Jie Chen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    PIK3CA E545A

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    130 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Glycopyrrolate
    Arm Type
    Experimental
    Arm Description
    During induction of anesthesia, 0.2mg Glycopyrrolate was given intravenously to participants.
    Arm Title
    Anisodamine Group
    Arm Type
    Active Comparator
    Arm Description
    During induction of anesthesia,10mg of Anisodamine was given intramuscular injection
    Intervention Type
    Drug
    Intervention Name(s)
    Glycopyrrolate
    Intervention Description
    During induction of anesthesia, 0.2mg Glycopyrrolate was given intravenously
    Intervention Type
    Drug
    Intervention Name(s)
    Anisodamine
    Intervention Description
    During induction of anesthesia,10mg of Anisodamine was given intramuscular injection.
    Primary Outcome Measure Information:
    Title
    Incidence of postoperative nausea and vomiting
    Time Frame
    Timepoint:24 hours after the ERCP

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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 -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jie Chen
    Phone
    13527517763
    Email
    13527517763@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Guangyou Duan
    Organizational Affiliation
    The Second Affiliated Hospital of Chongqing Medical University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effect of Glycopyrrolate on Nausea and Vomiting After ERCP Operation

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