Propofol-Ketamine versus Midazolam-Ketamine for sedation in patients undergoing cataract surgery by phacoamulsification method.

Comparison of the effect of ketamine-propofol and ketamine-midazolam on the sedation level during cataract surgery by phacoamulsification method

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20170809035601N7

Enrollment

Registered

2018-08-28

Start date

2017-12-02

Completion date

Unknown

Last updated

2018-09-11

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: 0.5 mg/kg Ketamine with 1 mg/kg propofol in a syringe titre is injected. In case of need, 20 mg of ketamine is injected and recorded as a rescue dose and at the e

Eligibility

Sex/Gender

All

Age

30 Years to 88 Years

Inclusion criteria

Inclusion criteria: Patients who are candidates for cataract surgery. Patients who are satisfied to enter the study. Patients aged 30-88 years.

Exclusion criteria

Exclusion criteria: History of allergy or allergic reaction to any of the medication used in the study. History of head injuries. High intraocular pressure or intracranial pressure. Cardiovascular risk. Severe respiratory disease. Advanced epilepsy or history of seizure or neurological disorder. 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 Arterial Pressure. Timepoint: Before the Procedure, During the process every 10 minutes and in recovery every 10 minutes up to two hours. Method of measurement: pressure gauge.;Heart rate. Timepoint: Before the Procedure, During the process every 10 minutes and in recovery every 10 minutes up to two hours. Method of measurement: Pulse oximeter.;Arterial oxygen saturation. Timepoint: Before the Procedure, During the process every 10 minutes and in recovery every 10 minutes up to two hours. Method of measurement: Pulse oximeter.;Intensity of pain. Timepoint: During the process every 10 minutes and in recovery every 10 minutes up to two hours. Method of measurement: Universal Pain assessment tool.;Frequency of complications. Timepoint: During the process every 10 minutes and in recovery every 10 minutes up to two hours. Method of measurement: Adverse drug reaction questionnaire.;Recovery time. Timepoint: After completing the procedure until the exit from the recovery. Method of measurement: Minute Numbers.;Surgeon Satisfaction. Timepoint: During the procedure. Method of measurement: Likert scale.	—

Measure

Time frame

Mean Arterial Pressure. Timepoint: Before the Procedure, During the process every 10 minutes and in recovery every 10 minutes up to two hours. Method of measurement: pressure gauge.;Heart rate. Timepoint: Before the Procedure, During the process every 10 minutes and in recovery every 10 minutes up to two hours. Method of measurement: Pulse oximeter.;Arterial oxygen saturation. Timepoint: Before the Procedure, During the process every 10 minutes and in recovery every 10 minutes up to two hours. Method of measurement: Pulse oximeter.;Intensity of pain. Timepoint: During the process every 10 minutes and in recovery every 10 minutes up to two hours. Method of measurement: Universal Pain assessment tool.;Frequency of complications. Timepoint: During the process every 10 minutes and in recovery every 10 minutes up to two hours. Method of measurement: Adverse drug reaction questionnaire.;Recovery time. Timepoint: After completing the procedure until the exit from the recovery. Method of measurement: Minute Numbers.;Surgeon Satisfaction. Timepoint: During the procedure. 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 313668555

Outcome results

None listed

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