A comparative study on the effect of fentanyl-propofol and pethidine-propofol on sedation level during cataract surgery by phacoamulsification method

Comparison of the effect of fentanyl-propofol and pethidine-propofol on the sedation level during cataract surgery by phacoamulsification method

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180416039326N1

Enrollment

Registered

2018-07-07

Start date

2017-03-21

Completion date

Unknown

Last updated

2018-09-11

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

Conditions

Cataract surgery. Unspecified disorder of vitreous body

Interventions

Intervention 1: Intervention group: first: the combination of fentanyl- propofol. Syringe 1 contains fentanyl 1.5 mcg / kg, which is added by adding 5 cc water. Syringe 3 contains Propofol 0.4 mg / kg

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Patients aged 35 to 85 years Patients undergoing cataract surgery by phacoemulsification Patients undergoing local anesthetic sedation in the first and second classes of the American Anesthetic Association

Exclusion criteria

Exclusion criteria: History of any allergy to the drug used in the design History of drug addiction, alcohol, benzodiazepine Pregnancy Congestive heart failure History of head trauma Glaucoma Hypotension Evidence of increased intracranial pressure Psychosis Schizophrenia Active upper respiratory tract infection Asthma Chronic respiratory disease

Design outcomes

Primary

Measure	Time frame
Sedation level based on ramsay score. Timepoint: Every 5 minutes during surgery. Method of measurement: Ramsay score.	—

Secondary

Measure	Time frame
Arterial pressure. Timepoint: Before intervention, every 5 minutes after the intervention and every 10 minutes after the end of the intervention for 30 minutes. Method of measurement: pressure gauge.;Oxygen saturation. Timepoint: Before intervention, every 5 minutes after the intervention and every 10 minutes after the end of the intervention for 30 minutes. Method of measurement: Pulse oximeter.;Heart rate. Timepoint: Before intervention, every 5 minutes after the intervention and every 10 minutes after the end of the intervention for 30 minutes. Method of measurement: Pulse oximeter.;Intensity of pain. Timepoint: every 5 minutes after the intervention and every 10 minutes after the end of the intervention for 30 minutes. Method of measurement: Universal Pain assessment tool.;Recovery time. Timepoint: After completing the intervention until the withdrawal from the recovery. Method of measurement: Minute Numbers.	—

Measure

Time frame

Arterial pressure. Timepoint: Before intervention, every 5 minutes after the intervention and every 10 minutes after the end of the intervention for 30 minutes. Method of measurement: pressure gauge.;Oxygen saturation. Timepoint: Before intervention, every 5 minutes after the intervention and every 10 minutes after the end of the intervention for 30 minutes. Method of measurement: Pulse oximeter.;Heart rate. Timepoint: Before intervention, every 5 minutes after the intervention and every 10 minutes after the end of the intervention for 30 minutes. Method of measurement: Pulse oximeter.;Intensity of pain. Timepoint: every 5 minutes after the intervention and every 10 minutes after the end of the intervention for 30 minutes. Method of measurement: Universal Pain assessment tool.;Recovery time. Timepoint: After completing the intervention until the withdrawal from the recovery. Method of measurement: Minute Numbers.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamidreza Shetabi

Esfahan University of Medical Sciences

Hamidshetabi@med.mui.ac.ir+98 31 3668 8138

Outcome results

None listed

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