Skip to content

Comparison of sedative and analgesic effects of two combinations of dexmethomidine-ketamine (Ketodex) and propofol-fentanyl (Fenofol)

A comparative study of the sedative and analgesic effects of two combinations of dexmethomidine-ketamine (Ketodex) and propofol-fentanyl (Fenofel) in patients undergoing endoscopic retrograde cholangiopancreatography.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20160307026950N55
Enrollment
120
Registered
2023-12-14
Start date
2023-12-22
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Analgesia and sedation in patients undergoing endoscopic retrograde cholangiopancreatography.

Interventions

Intervention 1: The first intervention group: received 1 µg/kg of fentanyl and 1 mg/kg of propofol in 30 seconds and then propofol injection at 2 to 4 mg/kg per hour. The second intervention group: 0.

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age over 18 years Consent to enter the study Patients who are candidates for endoscopic retrograde cholangiopancreatography Patients with American Society of Anesthesiologists (ASA) I,II

Exclusion criteria

Exclusion criteria: Patients with high blood pressure, coronary heart disease and central nervous system disorders Patients with known allergies to study drugs pregnancy Airway's disease

Design outcomes

Primary

MeasureTime frame
Sedation rate of patients. Timepoint: The base time (before the start of the intervention) and then every 15 minutes in the operating room and in the first hour of recovery every 15 minutes to 45 minutes and then in the 2nd and 4th hours after ERCP were recorded. Method of measurement: The level of patients sedation will be evaluated using the Modified Aldrete score,whose validity and reliability have been confirmed by a recent stud.;Analgesia of patients. Timepoint: The base time (before the start of the intervention) and then every 15 minutes in the operating room and in the first hour of recovery every 15 minutes to 45 minutes and then in the 2nd and 4th hours after ERCP were recorded. Method of measurement: Painlessness of patients will be evaluated using the Visual Analogue Scale (VAS) whose validity and reliability have been confirmed by a recent study.

Secondary

MeasureTime frame
Systolic blood pressure. Timepoint: The base time (before the start of the intervention) and then every 15 minutes in the operating room and in the first hour of recovery every 15 minutes to 45 minutes and then in the 2nd and 4th hours after ERCP were recorded. Method of measurement: Barometer.;Diastolic blood pressure. Timepoint: The base time (before the start of the intervention) and then every 15 minutes in the operating room and in the first hour of recovery every 15 minutes to 45 minutes and then in the 2nd and 4th hours after ERCP were recorded. Method of measurement: Barometer.;Pulse rate. Timepoint: The base time (before the start of the intervention) and then every 15 minutes in the operating room and in the first hour of recovery every 15 minutes to 45 minutes and then in the 2nd and 4th hours after ERCP were recorded. Method of measurement: ECG.;Respiratory rate. Timepoint: The base time (before the start of the intervention) and then every 15 minutes in the operating room and in the first hour of recovery every 15 minutes to 45 minutes and then in the 2nd and 4th hours after ERCP were recorded. Method of measurement: Breaths per minute stopwatch.;Oxygen saturation. Timepoint: The base time (before the start of the intervention) and then every 15 minutes in the operating room and in the first hour of recovery every 15 minutes to 45 minutes and then in the 2nd and 4th hours after ERCP were recorded. Method of measurement: Pulse oximeter.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSorour sadat Asayesh

Esfahan University of Medical Sciences

sorourasayesh@gmail.com+98 31 3627 9414

Outcome results

None listed

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