Comparing the effectiveness of intravenous and sublingual administration of midazolam for sedation of patients who are candidates for upper gastrointestinal endoscopy.

Phase 2

Recruiting

• Conditions: The effect of medicine on the level of sedation, pain and discomfort and satisfaction of patients who are candidates for upper gastrointestinal endoscopy.

• Registration Number: IRCT20100102002963N36
• Lead Sponsor: Yazd University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Adult patients who are candidates for upper gastrointestinal endoscopy who undergo diagnostic endoscopy for the first time

Exclusion Criteria

Existence of moderate to severe systemic disease
history of using of sedative or tranquilizer drugs
addiction to opioids or any sedative or psychotropic drugs
disagreement for cooperation in this study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The level of sedation. Timepoint: Before endoscopy. Method of measurement: A sedation score from 1 to 6 is given to each patient. In this way, score 1: the patient is awake, anxious and restless. Score 2: The patient is awake, alert, calm and cooperative. Score 3: The patient is awake and obeys orders. Score 4: The patient is asleep and responds quickly to stimulation (gentle blow to the forehead or loud sound stimulation). Score 5: The patient is asleep and gives a weak response to stimulation (gentle blow to the forehead area or loud sound stimuli). Score 6: The patient is asleep and does not respond to stimulation (gentle blow to the forehead area) or loud sound.

Secondary Outcome Measures

Name	Time	Method
The level of Pain/discomfort. Timepoint: Before endoscopy. Method of measurement: Pain/discomfort Score(0-10).;The level of satisfaction that gave a score of 1 to 10 for each patient. Timepoint: Before endoscopy. Method of measurement: Satisfaction Score(0-10).