A comparison of sedative effect with dexmedetomidine -fentanyl versus midazolaml–fentanyl during cataract surgery with phacoemulsification technique

Comparison of the sedative effect with Dexmedetomidine-Midazolam and Fentanyl- Midazolam in patients who candidated for Phacoemulsification cataract surgery referred to Isfahan Feyz hospital from 2017-2018

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180416039326N3

Enrollment

Registered

2018-10-15

Start date

2018-06-11

Completion date

Unknown

Last updated

2018-11-05

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:patient in group (FD) received 1µg/kg Fentanyl with 0/5 µg/kg Dexmedetomidine in 20cc Normal salin for 10 minutes and then the continuous infusion of Dexmedetomidin

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

Inclusion criteria: patients aged 18–85 years old ASA class 1 & 2 scheduled for phacoemulsification cataract surgery

Exclusion criteria

Exclusion criteria: refusing, mentally challenged patients , history of chronic use of sedatives, narcotics or alcohol , allergy to any of the study medications , patients with severe chronic obstructive pulmonary disease, Asthma,, history of cardiac disease (cardiac block and bradycardia) bradycardia (heart rate less than 50 beats per minute), systolic blood pressure less than 90 mm, Severe hepatic failure, uncontrolled diabetes, left ventricular failure (EF less than 30), and cerebrovascular disease,severe renal failures

Design outcomes

Primary

Measure	Time frame
Sedation level. Timepoint: Every 5 minutes during surgery. Method of measurement: Ramsay sedation score.	—

Secondary

Measure	Time frame
Medium atrial Blood pressure. Timepoint: Immediately before surgery, every 5 minutes during surgery and every 10 minutes for 30 minutes in recovery. Method of measurement: Pressure gauge.;Oxygen saturation percentage. Timepoint: Immediately before surgery, every 5 minutes during and after surgery every 10 minutes for 30 minutes in recovery. Method of measurement: Pulse oximetry.;Heart rate. Timepoint: Immediately before surgery, every 5 minutes during and after surgery every 10 minutes for 30 minutes in recovery. Method of measurement: Pulse oximetry.;Surgeon satisfaction. Timepoint: Immediately before surgery, every 5 minutes during and after surgery every 10 minutes for 30 minutes in recovery. Method of measurement: Likert questionnaire.;Patient satisfaction. Timepoint: Immediately before surgery, every 5 minutes during and after surgery every 10 minutes for 30 minutes in recovery. Method of measurement: Likert questionnaire.;Adverse drug reactions. Timepoint: Immediately before surgery, every 5 minutes during and after surgery every 10 minutes for 30 minutes in recovery. Method of measurement: Adverse drug reaction questionnaire.;Pain intensity. Timepoint: Immediately before surgery, every 5 minutes during and after surgery every 10 minutes for 30 minutes in recovery. Method of measurement: Universal Pain assessment tool.;Recovery time. Timepoint: After completing the intervention until the withdrawal from the recovery. Method of measurement: Minutes.	—

Measure

Time frame

Medium atrial Blood pressure. Timepoint: Immediately before surgery, every 5 minutes during surgery and every 10 minutes for 30 minutes in recovery. Method of measurement: Pressure gauge.;Oxygen saturation percentage. Timepoint: Immediately before surgery, every 5 minutes during and after surgery every 10 minutes for 30 minutes in recovery. Method of measurement: Pulse oximetry.;Heart rate. Timepoint: Immediately before surgery, every 5 minutes during and after surgery every 10 minutes for 30 minutes in recovery. Method of measurement: Pulse oximetry.;Surgeon satisfaction. Timepoint: Immediately before surgery, every 5 minutes during and after surgery every 10 minutes for 30 minutes in recovery. Method of measurement: Likert questionnaire.;Patient satisfaction. Timepoint: Immediately before surgery, every 5 minutes during and after surgery every 10 minutes for 30 minutes in recovery. Method of measurement: Likert questionnaire.;Adverse drug reactions. Timepoint: Immediately before surgery, every 5 minutes during and after surgery every 10 minutes for 30 minutes in recovery. Method of measurement: Adverse drug reaction questionnaire.;Pain intensity. Timepoint: Immediately before surgery, every 5 minutes during and after surgery every 10 minutes for 30 minutes in recovery. Method of measurement: Universal Pain assessment tool.;Recovery time. Timepoint: After completing the intervention until the withdrawal from the recovery. Method of measurement: Minutes.

—

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