Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06041984
Other study ID # 2023114
Secondary ID
Status Enrolling by invitation
Phase Phase 1/Phase 2
First received
Last updated
Start date October 8, 2023
Est. completion date June 2024

Study information

Verified date December 2023
Source The Second Affiliated Hospital of Chongqing Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the antiperistaltic effect and safety of glycopyrrolate and whether the use of glycopyrrolate is beneficial for colonoscopy and colonoscopic polypectomy.


Description:

Colonic spasm is a major adverse event affecting colonoscopy.The current mainstay for the prevention of colonic spasm is the use of antispasmodic.Glycopyrrolate is a long-acting quaternary ammonium anticholinergic drug.The study is designed as a randomized, double-blind, placebo-controlled study of the efficacy and safety of glycopyrrolate in participants receiving colonoscopy and colonoscopic polypectomy. Patients at our center who met the inclusion criteria were randomized into the glycopyrrolate group and the placebo group, and then statistically analyzed whether there was any difference in the incidence of spasticity, spasticity scores, polyp treatment time, and satisfaction with endoscopist operation between the two groups.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 150
Est. completion date June 2024
Est. primary completion date April 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Age 18-80 years old. - Outpatients and inpatients with lesions to be resected under colonoscopy. - Participants voluntarily participated and signed informed consent forms. Exclusion Criteria: - Pregnancy status and lactating women. - With glaucoma, myasthenia gravis, hyperthyroidism, chronic renal insufficiency, and inflammatory bowel disease. - With obstructive gastrointestinal diseases such as pyloric obstruction, paralytic ileus, and achalasia of the cardia. - With obstructive urinary tract diseases such as prostatic hyperplasia and dysuria. - With heart disease such as arrhythmia (bradycardia, tachycardia, ventricular fibrillation, atrial fibrillation, etc.), coronary heart disease, congestive heart failure. - With a history of previous abdominal or intestinal surgery. - Anticholinergic drugs were administered 48 hours before surgery.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Glycopyrrolate
Intravenous injection of glycopyrrolate 0.2mg
Other:
Placebo
Intravenous injection of saline 1ml

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 intestinal spasm The incidence of intestinal spasm in the two groups was calculated after determining whether colonic spasms occurred according to the inhibitory effect score.Rated on a scale of 1 to 3 according to the luminal opening diameter:1 (excellent): no spasm,lumen opening = 2/3 of maximum diameter, 2 (fair): moderate spasm,lumen opening < 2/3 of maximum diameter, but the oral side can be seen and 3 (poor): severe spasm,the oral side lumen is not visible. During Colonoscopy
Secondary inhibitory effect score Rated on a scale of 1 to 3 according to the luminal opening diameter:1 (excellent): no spasm,lumen opening = 2/3 of maximum diameter, 2 (fair): moderate spasm,lumen opening < 2/3 of maximum diameter, but the oral side can be seen and 3 (poor): severe spasm,the oral side lumen is not visible. During Colonoscopy
Secondary Polyp Treatment Time Time from start of polyp removal to complete polyp removal. During Colonoscopy
See also
  Status Clinical Trial Phase
Completed NCT04101097 - Training and Validation of Models of Factors to Predict Inadequate Bowel Preparation Colonoscopy
Completed NCT03247595 - Testing How Well Magnesium Citrate Capsules Work as Preparation for a Colonoscopy N/A
Completed NCT04214301 - An Open-Label Preference Evaluation of BLI800 Phase 4
Withdrawn NCT05754255 - Comparison of High-flow Oxygen With or Without Nasal Positive Airway Pressure (PAP) During Propofol Sedation for Colonoscopy in an Ambulatory Surgical Center N/A
Recruiting NCT02484105 - Comforting Conversation During Colonoscopy: A Trial on Patient Satisfaction Phase 4
Active, not recruiting NCT02264249 - Residual Gastric Volume in Same Day Versus Split Dose and Evening Before Bowel Preparation N/A
Completed NCT01964417 - The Comparative Study Between Bowel Preparation Method Phase 3
Terminated NCT01978509 - The Affect of Low-Volume Bowel Preparation for Hospitalized Patients Colonoscopies N/A
Recruiting NCT01685970 - Comparison of Same-day 2 Sachets Picosulfate Versus High Volume PEG for Afternoon Colonoscopy Phase 3
Completed NCT01518790 - Short Course, Single-dose PEG 3350 for Colonoscopy Prep in Children N/A
Recruiting NCT00748293 - Achievement of Better Examinee Compliance on Colon Cleansing Using Commercialized Low-Residue Diet N/A
Completed NCT00779649 - MoviPrep® Versus HalfLytely®, Low-VolUme PEG Solutions for Colon Cleansing: An InvesTigator-blindEd, Randomized, Trial Phase 4
Completed NCT00671177 - Clinical Evaluation of Water Immersion Colonoscopy Insertion Technique N/A
Completed NCT00380497 - Pico-Salax Versus Poly-Ethylene Glycol for Bowel Cleanout Before Colonoscopy in Children Phase 4
Recruiting NCT00160823 - Impact of a Self-Administered Information Leaflet on Adequacy of Colonic Cleansing for in-Hospital Patients Phase 3
Completed NCT00390598 - PEG Solution (Laxabon®) 4L Versus Senna Glycoside (Pursennid® Ex-Lax) 36mg and PEG Solution (Laxabon®) 2L for Large Bowel Cleansing Prior to Colonoscopy Phase 2/Phase 3
Completed NCT00314418 - Patient Position and Impact on Colonoscopy Time N/A
Completed NCT00427089 - Comparison of 2L NRL994 With NaP Preparation in Colon Cleansing Prior to Colonoscopies for Colon Tumor Screening Phase 3
Completed NCT00209573 - A Study of AQUAVAN® Injection Versus Midazolam HCl for Sedation in Patients Undergoing Elective Colonoscopy Phase 3
Completed NCT05823350 - The Effect of Abdominal Massage on Pain and Distention After Colonoscopy N/A