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Effect of midazolam-fentanyl versus propofol-ketamine sedation for peribulbar nerve block

Comparison of midazolam-fentanyl versus propofol-ketamine sedation for peribulbar nerve block

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013072911676N2
Enrollment
70
Registered
2013-10-09
Start date
2013-08-13
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Sedation in peribulbar block cataract surgery. Senile cataract, unspecified

Interventions

Intervention 1: Intervention group (group pk): A minidose of lidocaine (10mg) for local anesthesia of the vein endothelium was injected through the Intravenous catheter 1 min before the injection of
maximal dose 2 mg) or fentanyl (50 mg/ mL
maximal dose 2 mL) could be administered to keep the patient comfortable but awake and responsive.
Treatment - Drugs
Intervention group (group pk): A minidose of lidocaine (10mg) for local anesthesia of the vein endothelium was injected through the Intravenous catheter 1 min before the injection of propofol. The as
Control group(group mf):The patients received either 1 microg/kg of fentanyl and 0.02 mg/kg of midazolam by bolus IV injection 1 minute before the administration of a PRBB. At the discretion
maximal dose 2 mL) could be administered to keep the patient comfortable but awake and responsive

Sponsors

Vice chancellor for Research, Tehran University of Medical Sciences and Health Services
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion creteria: ASA 1-3; patients older than 60 yr of age (max 80 yr) undergoing cataract extraction and intraocular lens implantation on an ambulatory surgery. Patients were excluded if: they weighed 150% of their ideal body weight; had ischemic heart disease; had uncontrolled hypertension (systolic/diastolic blood pressure 180/ 110 mm Hg) or had a history of allergy to ketamine, propofol, or local anesthetic drugs; had a history of psychiatric disorders; suffered memory or cognitive dysfunction; had ingested a opoids, tranquilizer or psychoactive drug within 2 wk of surgery.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Patient satisfaction. Timepoint: 3 to 5 min after injection. Method of measurement: Question.;Quality of sedation. Timepoint: During injection. Method of measurement: Scale.

Secondary

MeasureTime frame
Hemodynamic (systolic, diastolic and mean BP, heart rate). Timepoint: 1 min after sedation and 3 min after injection. Method of measurement: Automated hemodynamic monitoring , electrocardiogram.;Spo2. Timepoint: 1-min after sedation and at 3 min after injection PBB. Method of measurement: Pulse oximeter.;Degree of respiratory depression. Timepoint: 1-min after sedation and at 3 min after injection PBB. Method of measurement: Table of score.;Air way intervention. Timepoint: 1-min after sedation and at 3 min after injection PBB. Method of measurement: Table of score.;Side effects of drugs. Timepoint: During operation. Method of measurement: Record.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAbbas Ostadalipour

Tehran University of Medical Sceinces

a-ostadalipour@tums.ac.ir+98 21 5541 4104

Outcome results

None listed

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