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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20100102002963N36

Enrollment

Registered

2022-09-13

Start date

2022-09-23

Completion date

Unknown

Last updated

2022-11-21

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

Conditions

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

Interventions

Intervention 1: Intervention group: Before the procedure, patients are given 2.5 mg of intravenous midazolam and 1 ml of normal saline sublingually. Intervention 2: Intervention group: Patients are gi

Eligibility

Sex/Gender

All

Age

15 Years to 55 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Shekoufeh Behdad

Yazd University of Medical Sciences

drbehdad@ssu.ac.ir+98 35 3823 1932

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026