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A Comparison between the sedative effect of Fentanyl and Ketamine outside the operating room.

A Comparison between the effect of Propofol Fentanyl and Propofol Ketamine on Colonoscopy patients' sedation.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200818048445N1
Enrollment
144
Registered
2020-10-28
Start date
2020-04-18
Completion date
Unknown
Last updated
2020-11-30

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

Conditions

Pain management of patients referred for Colonoscopy and reduce their anxiety.

Interventions

Intervention 1: The first intervention group: The group receiving Propofol Fentanyl for sedation during Colonoscopy. Intervention 2: Intervention group 2: The group receiving Propofol Ketamine for sed

Sponsors

Ahvaz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: They are between 18 and 65 years old Patients are referred for colonoscopy procedure Classification of Group 1 and 2 American Society of Anesthesiologists (ASA Class I & II) are selected as inclusion criteria.

Exclusion criteria

Exclusion criteria: the patient's unwillingness to participate in the study They are under 18 years old They are over 65 years old They have kidney failure They have liver failure They have chronic pain syndrome They are addicted They have any drug allergies They have cardiovascular disease They have a respiratory disease They have metabolic diseases They have a neurological disease They have difficult airways The patient is classified as ASA class 3 and 4 Contraindicated propofol ketamine or propofol fentanyl

Design outcomes

Primary

MeasureTime frame
A score of 5 or 6 RAMSAY criteria in the questionnaire. RAMSAY sedation criteria including 6 scores is as follows: 1. Completely awake and anxious 2. Quiet and calm with enough cooperation 3. Asleep and wakes up with a verbal command 4. Asleep and woke up with mild stimulation, but gives a strong reaction to painful stimuli 5. Slow reaction to painful stimuli 6. Lack of reaction to painful stimuli. Timepoint: 5 minutes after the procedure, 10 minutes after the procedure, 15 minutes after the procedure. Method of measurement: Verbal measurement criteria.

Secondary

MeasureTime frame
The amount of pain. Timepoint: Start of procedure , end of procedure and one hour after the end of the procedure. Method of measurement: The Ambesh criterion, which includes the following four-point grading questions: 1. No pain: Negative answer to questions about having pain 2. Mild: Positive answers to questions about having pain, but without any physical symptoms 3. Medium: Positive answers to questions about having pain and the appearance of physical symptoms or successive complaints of pain 4. Intensity: The patient verbally complains of severe pain or shows pain with frowning and upset in the face or turning away with hand or expressing fear.;Recovery time. Timepoint: Recovery time is defined as fast (less than 5 minutes), medium (between 5 to 10 minutes) and slow (more than 15 minutes). Method of measurement: Patient's appropriate answers to questions.;Nausea. Timepoint: Every 5 minutes. Method of measurement: It is expressed by the person herself/himself.;Systolic blood pressure. Timepoint: Every 5 minutes. Method of measurement: Blood pressure monitor.;Diastolic blood pressure. Timepoint: Every 5 minutes. Method of measurement: Blood pressure monitor.;Heart beat. Timepoint: every 5 minutes. Method of measurement: Cardiac monitor.;Arterial blood oxygen saturation. Timepoint: Every 5 minutes. Method of measurement: Respiratory monitor.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactBaghbanian reza

Ahvaz University of Medical Sciences

hosseinpour.m@ajums.ac.ir+98 61 3376 5834

Outcome results

None listed

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