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

Phase 2

• Conditions: Cataract surgery.; Unspecified disorder of vitreous body

• Registration Number: IRCT20180416039326N1
• Lead Sponsor: Esfahan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 September 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 80

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.