Comparison of Dexmedetomidine and Midazolam Anesthesia Effect in Elderly Patients during Cataract Surgery

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200510047389N1

Enrollment

130

Registered

2020-05-17

Start date

2020-05-14

Completion date

Unknown

Last updated

2020-06-15

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

Conditions

Cataract Surgery. Cataract in diseases classified elsewhere

Interventions

Intervention 1: Intervention group: Patients in first group receiving Dexmedetomidine 1 Mic/kg by slow infusion. Intervention 2: Intervention group: Patients in second group receiving Midazolam 0.02

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients over 65 years old candidate for Cataract Surgery with ASA 2-3 No allergy to any of the study medications

Exclusion criteria

Exclusion criteria: Hemodynamic changes over 30% that needed intervention Patient who refusing Severe drug complications History of using opioid and alcohol Changing the method of anesthesia Severe chronic disease

Design outcomes

Primary

Measure	Time frame
Sedation level. Timepoint: Every 5 minutes during surgery. Method of measurement: Modified Observers Assessment of Alertness/Sedation Scale.	—

Secondary

Measure	Time frame
Systolic Blood pressure. Timepoint: Before the anesthesia, 2, 5, 10, 15 minutes after the start of surgery, Every 15 minute during the surgery, Entering the recovery and 1 hour after the recovery. Method of measurement: Monitoring device.;Diastolic blood pressure. Timepoint: Before the anesthesia, 2, 5, 10, 15 minutes after the start of surgery, Every 15 minute during the surgery, Entering the recovery and 1 hour after the recovery. Method of measurement: Monitoring device.;Mean arterial Blood pressure. Timepoint: Before the anesthesia, 2, 5, 10, 15 minutes after the start of surgery, Every 15 minute during the surgery, Entering the recovery and 1 hour after the recovery. Method of measurement: Monitoring device.;Heart rate. Timepoint: Before the anesthesia, 2, 5, 10, 15 minutes after the start of surgery, Every 15 minute during the surgery, Entering the recovery and 1 hour after the recovery. Method of measurement: Heart rate monitoring device.;Arterial oxygen saturation percentage. Timepoint: Before the anesthesia, 2, 5, 10, 15 minutes after the start of surgery, Every 15 minute during the surgery, Entering the recovery and 1 hour after the recovery. Method of measurement: Pulse oximetry.;Pain level. Timepoint: Entering the recovery; Every 15 minute in the recovery. Method of measurement: Visual Analog Scale.;Surgeon satisfaction. Timepoint: Before the anesthesia, 2, 5, 10, 15 minutes after the start of surgery, Every 15 minute during the surgery, Entering the recovery and 1 hour after the recovery. Method of measurement: Likert questionnaire.;Patient satisfaction. Timepoint: Before the anesthesia, 2, 5, 10, 15 minutes after the start of surgery, Every 15 minute during the surgery, Entering the recovery and 1 hour after the recovery. Method of measurement: Likert questionnaire.	—

Measure

Time frame

Systolic Blood pressure. Timepoint: Before the anesthesia, 2, 5, 10, 15 minutes after the start of surgery, Every 15 minute during the surgery, Entering the recovery and 1 hour after the recovery. Method of measurement: Monitoring device.;Diastolic blood pressure. Timepoint: Before the anesthesia, 2, 5, 10, 15 minutes after the start of surgery, Every 15 minute during the surgery, Entering the recovery and 1 hour after the recovery. Method of measurement: Monitoring device.;Mean arterial Blood pressure. Timepoint: Before the anesthesia, 2, 5, 10, 15 minutes after the start of surgery, Every 15 minute during the surgery, Entering the recovery and 1 hour after the recovery. Method of measurement: Monitoring device.;Heart rate. Timepoint: Before the anesthesia, 2, 5, 10, 15 minutes after the start of surgery, Every 15 minute during the surgery, Entering the recovery and 1 hour after the recovery. Method of measurement: Heart rate monitoring device.;Arterial oxygen saturation percentage. Timepoint: Before the anesthesia, 2, 5, 10, 15 minutes after the start of surgery, Every 15 minute during the surgery, Entering the recovery and 1 hour after the recovery. Method of measurement: Pulse oximetry.;Pain level. Timepoint: Entering the recovery; Every 15 minute in the recovery. Method of measurement: Visual Analog Scale.;Surgeon satisfaction. Timepoint: Before the anesthesia, 2, 5, 10, 15 minutes after the start of surgery, Every 15 minute during the surgery, Entering the recovery and 1 hour after the recovery. Method of measurement: Likert questionnaire.;Patient satisfaction. Timepoint: Before the anesthesia, 2, 5, 10, 15 minutes after the start of surgery, Every 15 minute during the surgery, Entering the recovery and 1 hour after the recovery. Method of measurement: Likert questionnaire.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahgolsadat Matinkhah

Esfahan University of Medical Sciences

Mahgol_mtn72@yahoo.de+98 31 3260 3538

Outcome results

None listed

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