Studying the difference between propofol and a combination of propofol and midazolam in endoscopic and colonoscopy sedation

Comparison of the effects of propofol alone and the combination of midazolam and propofol in sedation of outpatients for gastrointestinal endoscopy and colonoscopy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250217064758N1

Enrollment

166

Registered

2025-02-24

Start date

2025-04-04

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

In this study, the quality of patients' recovery and their satisfaction with propofol and the combination of propofol with midazolam will be investigated using Ramsey Score, Aldert Score, and VAS variables, and comparing patients' vital signs.. Other complications of anaesthesia

Interventions

Intervention 1: Intervention group: Intervention group: In the propofol-only group, 40 to 60 mg of propofol (1 mg based on the patients body weight) will be administered intravenously, and 20 mg of pr

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: There will be patients who will visit Al-Zahra Hospital in Isfahan for colonoscopy and endoscopy on an outpatient basis. Have ASA Class I and II physical condition

Exclusion criteria

Exclusion criteria: Known sensitivity or allergy to study drugs pregnancy or lactation Risk of difficult intubation History of sleep apnea syndrome Taking sedatives and antidepressants History of complications from previous sedation

Design outcomes

Primary

Measure	Time frame
Average time to reach an Aldert score of 10 after anesthesia. Timepoint: Every 5 minutes from the end of anesthesia until discharge. Method of measurement: Aldert scoring form.;Sedation level during the procedure using the Ramsey score. Timepoint: Every 5 minutes from the start of anesthesia induction. Method of measurement: Ramsey Score Scoring Form.;Average patient and doctor satisfaction score. Timepoint: Before patient discharge. Method of measurement: Visual Analogue Scale.;Number of complications. Timepoint: From the time of induction of anesthesia to discharge. Method of measurement: Pre-prepared form.	—

Measure

Time frame

Average time to reach an Aldert score of 10 after anesthesia. Timepoint: Every 5 minutes from the end of anesthesia until discharge. Method of measurement: Aldert scoring form.;Sedation level during the procedure using the Ramsey score. Timepoint: Every 5 minutes from the start of anesthesia induction. Method of measurement: Ramsey Score Scoring Form.;Average patient and doctor satisfaction score. Timepoint: Before patient discharge. Method of measurement: Visual Analogue Scale.;Number of complications. Timepoint: From the time of induction of anesthesia to discharge. Method of measurement: Pre-prepared form.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactIman Izadi

Esfahan University of Medical Sciences

iman89110@gmail.com+98 31 3668 0048

Outcome results

None listed

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