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Comparison of the Effects of sublingual fentanyl and intravenous ketamine in phacoemulsification cataract surgery

Comparison of the Effects of sublingual fentanyl and intravenous ketamine on pain control and hemodynamic variables in phacoemulsification cataract surgery under sedation and local anesthesia

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180416039326N18
Enrollment
86
Registered
2021-03-08
Start date
2021-03-05
Completion date
Unknown
Last updated
2021-04-26

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

Conditions

cataract surgery. Unspecified cataract

Interventions

Intervention 1: Intervention group: In the sublingual fentanyl (SLF) group, fentanyl at a dose of 1.5µ / kg (up to 100 micrograms), which is reduced to 2 ml with normal saline, is administered subling

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients aged 50-75 with ASA (American Society of Anesthesiology) class 1 and 2 that Candidates for phycoemulsification cataract surgery who are willing to enter the study

Exclusion criteria

Exclusion criteria: History of any allergy or allergic reaction to any of medications used in the study pregnancy seizure or psychotic disorder preoperative hypotention Taking medication preoperatively (other than those mentioned before) Inflammation or any lesion of the oral cavity that interferes with sublingual administration of the drug increase intracranial pressure

Design outcomes

Primary

MeasureTime frame
Sedation level based on ramsay score. Timepoint: every 5 minutes during surgery and then in recovery every 15 minutes, until discharge from recovery. Method of measurement: Ramsay score.

Secondary

MeasureTime frame
Arterial blood pressure. Timepoint: Before surgery, during surgery every 5 minutes and in recovery every 15 minutes, until discharge from recovery. Method of measurement: pressure gauge.;Oxygen saturation. Timepoint: Before surgery, during surgery every 5 minutes and in recovery every 15 minutes, until discharge from recovery. Method of measurement: Pulse oximeter.;Heart rate. Timepoint: Before surgery, during surgery every 5 minutes and in recovery every 15 minutes, until discharge from recovery. Method of measurement: Pulse oximeter.;Intensity of pain. Timepoint: in recovery every 15 minutes, until discharge from recovery. Method of measurement: Universal Pain assessment tool.;Recovery time. Timepoint: After surgery until the discharge from the recovery. Method of measurement: Minute Numbers.;Patient satisfaction. Timepoint: At the time of discharge from recovery. Method of measurement: Likert questionnaire.;Surgeon satisfaction. Timepoint: after surgery. Method of measurement: Likert questionnaire.;Adverse drug reaction. Timepoint: During surgery and in recovery. Method of measurement: Adverse drug reaction questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamidreza Shetabi

Esfahan University of Medical Sciences

Hamidshetabi@med.mui.ac.ir+98 31 3668 8138

Outcome results

None listed

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