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The comparison analgesic effect of fentanyl plus midazolam or fentanyl plus propofol on patients during cataract surgery under peribulbar block

The comparison analgesic effect of fentanyl plus midazolam or fentanyl plus propofol on patients during cataract surgery under peribulbar block: A randomized clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230111057106N1
Enrollment
116
Registered
2023-02-23
Start date
2023-01-21
Completion date
Unknown
Last updated
2023-03-13

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

Conditions

catarct. Age-related cataract, morgagnian type

Interventions

Intervention 1: Intervention group: The intervention group receives a sedation with fentanyl 0.5g/kg and it is repeated for 5-10 minutes. After that, midazolam 0.01mg/kg - Hyalase patients also receiv

Sponsors

Guilan University Of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: Unilateral cataract surgery patients aged 50-80 years with ASA class I, II elective surgery fasting patients surgeries performed under peribulbar block by an ophthalmologist with more than 25 years of experience

Exclusion criteria

Exclusion criteria: ASA > 3 surgeries performed under other blocks or general anesthesia coagulation disorder use of antiplatelet drugs head tremor (Parkinson's) cognitive disorder Alzheimer's fear of closed spaces history of chronic cough addiction and history of use Analgesic drugs allergies to local anesthetic drugs non-cooperative patients

Design outcomes

Primary

MeasureTime frame
Degree of sedation using corrected Ramsay scale( RSS>3). Timepoint: Every 5 minutes. Method of measurement: Clinical examination.

Secondary

MeasureTime frame
Patient satisfaction level. Timepoint: Evaluation of patients' satisfaction using a five-point Likert scale, according to statistics, 33.3 is poor, 33.3-66.6 is average, and 66.6 or higher is good.between the end of surgery and transfer to the ward (recovery time). Method of measurement: In the study "The comparison analgesic effect of fentanyl plus midazolam or fentanyl plus propofol on patients during cataract surgery under peribulbar block", the way to set up the secondary variable of patient satisfaction can be a "five-point Likert scale". according to statistics, 33.3 is poor, 33.3-66.6 is average, and 66.6 or higher is good.;Surgeon satisfaction level. Timepoint: Evaluation of surgen's satisfaction using a five-point Likert scale, according to statistics, 33.3 is poor, 33.3-66.6 is average, and 66.6 or higher is good.between the end of surgery and transfer to the ward (recovery time). Method of measurement: In the study "The comparison analgesic effect of fentanyl plus midazolam or fentanyl plus propofol on patients during cataract surgery under peribulbar block", the method of setting up the secondary variable of surgeon satisfaction can be a five-point Likert scale. according to statistics, 33.3 is poor, 33.3-66.6 is average, and 66.6 or higher is good.;Anesthesia complications. Timepoint: Anesthesia complications is evaluated using a five-point Likert scale, according to statistics, 33.3 is poor, 33.3-66.6 is average, and 66.6 or higher is good. The time between the end of surgery and transfer to the ward (recovery time) is recorded. Method of measurement: In the study "The comparison analgesic effect of fentanyl plus midazolam or fentanyl plus propofol on patients during cataract surgery under peribulbar block", the secondary variable of anesthesia complications can be set up using a five-point Likert scale. according to statistics, 33.3 is poor, 33.3-66.6 is average, and 66.6 or higher is good.;Recovery time. Timepoint: Recovery time is evaluated using a

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Hassan behboudi

Guilan University of Medical Sciences

behboudi_dr@yahoo.com+98 13 3323 6886

Outcome results

None listed

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