Comparing the sedative effect of intranasal fentanyl and intranasal ketamine in phacoemulsification

Comparing the sedative effect of intranasal fentanyl and intranasal ketamine in phacoemulsification cataract surgery under sedation

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20170809035601N11

Enrollment

Registered

2019-07-16

Start date

2019-07-23

Completion date

Unknown

Last updated

2019-10-07

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: ketamine group intranasal ketamine 2 ml (1.5 mg/Kg) with maximum dosage of 100 mg administered in both nostrils. Intervention 2: Intervention group: fentanyl group

Eligibility

Sex/Gender

All

Age

30 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patients who are candidates for Phacoemulsification cataract surgery Patients who are satisfied to enter the study Patients aged 30-75 years old patients with ASA class 1 and 2

Exclusion criteria

Exclusion criteria: History of any allergy or allergic reaction to any of medications used in the study History of head injurys High intraocular pressure or intracranial pressure Cardiovascular risk Hypertension Severe respiratory disease Advanced liver disease Epilepsy or history of seizure Nervous system disorders The presence of any tumor or brain metastasis Use of any analgesic and anesthetic drug

Design outcomes

Primary

Measure	Time frame
Sedation level. Timepoint: After induction of anesthesia, during the procedure every 5 minutes. Method of measurement: Modified ramsay sedation scale (RSS).	—

Secondary

Measure	Time frame
Mean Atrial Pressure. Timepoint: Before surgery, every 5 minutes during surgery and after the surgery every 10 minutes for 30 minutes in recovery. Method of measurement: Pressure gauge.;Oxygen saturation percentage. Timepoint: Before surgery, every 5 minutes during surgery and after the surgery every 10 minutes for 30 minutes in recovery. Method of measurement: Pulse oximetry.;Heart rate. Timepoint: Before surgery, every 5 minutes during surgery and after the surgery every 10 minutes for 30 minutes in recovery. Method of measurement: Pulse oximetry.;Adverse drug reaction. Timepoint: Before surgery, every 5 minutes during surgery and after the surgery every 10 minutes for 30 minutes in recovery. Method of measurement: Adverse drug reaction questionnaire.;Recovery time. Timepoint: From the end of the surgery to the time exit Recovery. Method of measurement: Minute.;Surgeon satisfaction. Timepoint: End of surgery. Method of measurement: Likert scale.	—

Measure

Time frame

Mean Atrial Pressure. Timepoint: Before surgery, every 5 minutes during surgery and after the surgery every 10 minutes for 30 minutes in recovery. Method of measurement: Pressure gauge.;Oxygen saturation percentage. Timepoint: Before surgery, every 5 minutes during surgery and after the surgery every 10 minutes for 30 minutes in recovery. Method of measurement: Pulse oximetry.;Heart rate. Timepoint: Before surgery, every 5 minutes during surgery and after the surgery every 10 minutes for 30 minutes in recovery. Method of measurement: Pulse oximetry.;Adverse drug reaction. Timepoint: Before surgery, every 5 minutes during surgery and after the surgery every 10 minutes for 30 minutes in recovery. Method of measurement: Adverse drug reaction questionnaire.;Recovery time. Timepoint: From the end of the surgery to the time exit Recovery. Method of measurement: Minute.;Surgeon satisfaction. Timepoint: End of surgery. Method of measurement: Likert scale.

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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