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A study to compare the effect on tolerance with or without medication (Glycopyrrolate) in patients undergoing upper gastrointestinal endoscopy without sedation

Effect of premedication with glycopyrrolate on tolerance and procedure outcomes in patients undergoing unsedated upper gastrointestinal endoscopy â?? a randomized Placebo controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/07/026786
Enrollment
380
Registered
2020-07-25
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K229- Disease of esophagus, unspecified Health Condition 2: K319- Disease of stomach and duodenum, unspecified Health Condition 3: K23- Disorders of esophagus in diseasesclassified elsewhere Health Condition 4: K269- Duodenal ulcer, unspecified as acute or chronic, without hemorrhage or perforation Health Condition 5: K209- Esophagitis, unspecified Health Condition 6: K30- Functional dyspepsia Health Condition 7: K259- Gastric ulcer, unspecified as acute or chronic, without h

Interventions

Intervention1: Glycopyrrolate: 1 ml containing 0.2 mg diluted in 1 ml 0.9% saline intravenous route over 1 minute Control Intervention1: Placebo: 2 ml 0.9% normal saline intravenous over 1 minute

Sponsors

Jawaharlal Institute of Postgraduate Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged 18-60 years, undergoing unsedated diagnostic upper GI endoscopy

Exclusion criteria

Exclusion criteria: a. History of glaucoma b. Known cardio respiratory disease c. Persons with chronic constipation d. History of obstructive urinary disorders e. Prior gastrectomy f. Persons taking anti-anxiety medications g. Pregnancy h. History of prior upper GI endoscopy i. Active upper respiratory infection

Design outcomes

Primary

MeasureTime frame
1. To assess effect of premedication with glycopyrrolate on the level of patient tolerance during unsedated upper GI endoscopyTimepoint: 60 minutes

Secondary

MeasureTime frame
1. To study the cardio - respiratory fluctuations during unsedated upper GI endoscopy 2. To study the effect of premedication on the duration of unsedated upper GI endoscopy 3. To assess the number of failed endoscope intubations and incomplete endoscopies 4. To calculate the Endoscopistâ??s assessment score after the unsedated upper GI endoscopy Timepoint: 60 minutes

Countries

India

Contacts

Public ContactRamalingam R

JIPMER

ramlee0212@gmail.com04132297384

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 10, 2026