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Comparative study of efficacy and side effects of combination Nesdonal - Fentanyl - Midazolam with Etomidate - Fentanyl - Midazolam for sedation of patients undergoing cataract surgery

Comparative study of efficacy and side effects of combination Nesdonal - Fentanyl - Midazolam with Etomidate - Fentanyl - Midazolam for sedation of patients undergoing cataract surgery

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230715058780N1
Enrollment
52
Registered
2023-07-28
Start date
2023-08-05
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

Cataract surgery. Age-related incipient cataract

Interventions

Intervention 1: Intervention group: Intervention group: The FIRST group is first injected with midazolam and fentanyl intravenous bolus with the following dose: fentanyl 1 Microg/Kg, midazolam 0.02 Mg

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Cataract surgery candidates for emulsification method Having (ASA) between 1 and 3 Age between 18 and 70 years Consent to participate in the study

Exclusion criteria

Exclusion criteria: Parkinson's Occurrence of acute cardiac ischemia in the last three months Having a history of narcotic drugs use Having a history of allergy to anesthetics Pregnancy Weighing more than one hundred kilograms Baseline blood pressure greater than 180/110 Dyspenea Psychosis

Design outcomes

Primary

MeasureTime frame
Blood pressure. Timepoint: before receiving the drugs, after receiving, 5, 10, 20 minutes after the start of surgery and during recovery, first immediately and then every 15 minutes until leaving the recovery. Method of measurement: Operating room monitoring device.;Respiratory rate per minute. Timepoint: before receiving the drugs, after receiving, 5, 10, 20 minutes after the start of surgery and during recovery, first immediately and then every 15 minutes until leaving the recovery. Method of measurement: Operating room monitoring device.;Heart rate per minute. Timepoint: before receiving the drugs, after receiving, 5, 10, 20 minutes after the start of surgery and during recovery, first immediately and then every 15 minutes until leaving the recovery. Method of measurement: Operating room monitoring device.;Blood oxygen saturation percentage. Timepoint: before receiving the drugs, after receiving, 5, 10, 20 minutes after the start of surgery and during recovery, first immediately and then every 15 minutes until leaving the recovery. Method of measurement: Operating room monitoring device.;Determining and comparing the average length of stay in recovery Community Verified icon. Timepoint: After transfer to recovery until the end. Method of measurement: timer.;Determining and comparing the frequency of sedation. Timepoint: At the time of receiving the drugs and 5, 10, 20 minutes after the start of the surgery Community Verified icon. Method of measurement: Determining sedation with the Ramsay-Sedation-Scale.;Determining and comparing the frequency of surgeon satisfaction Community Verified icon. Timepoint: End of surgery. Method of measurement: CHECK LIST.

Secondary

MeasureTime frame
Determining and comparing the frequency of intramuscular metoclopramide consumption in recovery. Timepoint: After exiting recovery. Method of measurement: Determining nausea based on Baxter Retching Faces and metoclopromide injection in scores higher than 6 and counting doses.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mitra Jabal Ameli

Esfahan University of Medical Sciences

jabalameli@med.mui.ac.ir+98 31 3620 1992

Outcome results

None listed

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