A comparative study of administration of “midazolam-propofol”, “midazolam-ketamine”, “midazolam-fentanyl” and “midazolam alone” on sedation patients

A comparative study of administration of “midazolam-propofol”, “midazolam-ketamine”, “midazolam-fentanyl” and “midazolam alone” on sedation and hemodynamic parametric changes in patients Percutaneous coronary intervention (PCI)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200825048515N81

Enrollment

248

Registered

2025-06-06

Start date

2025-07-23

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Percutaneous coronary intervention. Coronary angioplasty status

Interventions

Intervention 1: First intervention group: Patients in this group will receive midazolam 2.5 mg for sedation as an intravenous bolus dose. Intervention 2: Second intervention group: Patients in this gr

Eligibility

Sex/Gender

All

Age

30 Years to 60 Years

Inclusion criteria

Inclusion criteria: PCI candidate patients Age range 30-60 years Hemodynamically stable ASA class I, II, or III ????? ?? ???? ?? ??????

Exclusion criteria

Exclusion criteria: Having severe cardiopulmonary disease Obesity (BMI> 30 kg/m2) Suspected or confirmed pregnancy History of allergic reaction to drugs used in the study Inability to communicate Having a history of mental and psychological disorders based on the patient's previous clinical reports (contraindication for ketamine administration) Having a history of seizures based on the patient's previous clinical reports (contraindication for ketamine administration) Addiction Reduced level of consciousness Having a history of stroke based on the patient's previous clinical reports (Contraindications for Ketamine Administration)

Design outcomes

Primary

Measure	Time frame
Sedation. Timepoint: Every 10 minutes during echocardiography. Method of measurement: Based on Ramsay criteria.;Hear rate. Timepoint: Before the start of the anesthesia intervention, every 10 minutes during echocardiography and at the beginning of the recovery period, and every 15 minutes in the recovery period. Method of measurement: Monitoring device.;Diastolic blood pressure. Timepoint: Before the start of the anesthesia intervention, every 10 minutes during echocardiography and at the beginning of the recovery period, and every 15 minutes in the recovery period. Method of measurement: Monitoring device.;Systolic blood pressure. Timepoint: Before the start of the anesthesia intervention, every 10 minutes during echocardiography and at the beginning of the recovery period, and every 15 minutes in the recovery period. Method of measurement: Monitoring device.	—

Measure

Time frame

Sedation. Timepoint: Every 10 minutes during echocardiography. Method of measurement: Based on Ramsay criteria.;Hear rate. Timepoint: Before the start of the anesthesia intervention, every 10 minutes during echocardiography and at the beginning of the recovery period, and every 15 minutes in the recovery period. Method of measurement: Monitoring device.;Diastolic blood pressure. Timepoint: Before the start of the anesthesia intervention, every 10 minutes during echocardiography and at the beginning of the recovery period, and every 15 minutes in the recovery period. Method of measurement: Monitoring device.;Systolic blood pressure. Timepoint: Before the start of the anesthesia intervention, every 10 minutes during echocardiography and at the beginning of the recovery period, and every 15 minutes in the recovery period. Method of measurement: Monitoring device.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAlireza Yazdani

Esfahan University of Medical Sciences

dr_alirezayazdani@yahoo.com+98 31 3260 0961

Outcome results

None listed

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