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omparison of sedation of ketofol -fentanyl-midazolam combination with popofol-fentanyl-midazolam in patients undergoing cataract surgery

Comparison of sedation of intravenous ketofol (ketamine + propofol)-fentanyl-midazolam combination with intravenous propofol-fentanyl-midazolam for patients undergoing cataract surgery

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20130311012782N64
Enrollment
60
Registered
2025-07-04
Start date
2025-09-23
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

Cataract. cataract

Interventions

Intervention 1: Intervention group1: At first, intravenous bolus fentanyl at a dose of 1 microgram/kg and midazolam at a dose of 0.15 mg/kg are administered as a bolus, and after 3 minutes, propofol a

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Candidates for cataract surgery using the emulsification method Having an ASA between 1 and 3 Age between 18 and 70 Being satisfied with participating in the study

Exclusion criteria

Exclusion criteria: Parkinson's disease, claustrophobia, shortness of breath, psychosis, Alzheimer's disease, acute cardiac ischemia in the last three months Having a history of drug use Having a history of allergy to anesthetic drugs Pregnancy Body mass index greater than or equal to 30 Having baseline blood pressure greater than 180/110 mmHg Changing surgical method, changing anesthesia method

Design outcomes

Primary

MeasureTime frame
Sedation level. Timepoint: Before receiving the medication, after receiving the medication, 5, 10, and 20 minutes after the start of surgery, during recovery, and every 15 minutes until leaving recovery. Method of measurement: Ramsay Sedetion score.;Post-operative pain. Timepoint: Before receiving the medication, after receiving the medication, 5, 10, and 20 minutes after the start of surgery, during recovery, and every 15 minutes until leaving recovery. Method of measurement: Visual Analog Scale.

Secondary

MeasureTime frame
Blood Pressure. Timepoint: Before receiving the medication, after receiving the medication, 5, 10, and 20 minutes after the start of surgery, during recovery, and every 15 minutes until leaving recovery. Method of measurement: Blood pressure machine.;Number of breaths. Timepoint: Before receiving the medication, after receiving the medication, 5, 10, and 20 minutes after the start of surgery, during recovery, and every 15 minutes until leaving recovery. Method of measurement: Pulse oximetry.;Heart rate. Timepoint: Before receiving the medication, after receiving the medication, 5, 10, and 20 minutes after the start of surgery, during recovery, and every 15 minutes until leaving recovery. Method of measurement: Pulse oximetry.;Blood oxygen saturation percentage. Timepoint: Before receiving the medication, after receiving the medication, 5, 10, and 20 minutes after the start of surgery, during recovery, and every 15 minutes until leaving recovery. Method of measurement: Pulse oximetry.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactKeyvan Mohamadi

Esfahan University of Medical Sciences

keyvan.mohamadi@gmail.com0098 36692174

Outcome results

None listed

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