A clinical trial to study the effects of two drugs, dexmedetomidine and midazolam as sedative agents during cardiopulmonary bypass.

Comparative study of hemodynamic and sedative effects of dexmedetomidine and midazolam with fentanyl in patients undergoing cardiopulmonary bypass for cardiac surgeries. A prospective randomized control trial.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/06/054407

Enrollment

200

Registered

2023-06-26

Start date

Unknown

Completion date

Unknown

Last updated

2023-08-21

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

Conditions

Health Condition 1: I39- Endocarditis and heart valve disorders in diseases classified elsewhere

Interventions

Intervention1: Dexmedetomidine: Dexmedetomidine bolus@ 0.5 microgram/kg over 20 minutes followed by 0.2microgram/kg/min to achieve desired BIS value between 40-50. Control Intervention1: Midazolam: M

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age- 18 year to 65 year 2. Both gender 3. Open heart surgery with Cardiopulmonary bypass 4. No end stage organ disease

Exclusion criteria

Exclusion criteria: 1. Emergency surgery 2. Surgery without cardiopulmonary bypass 3. Use of balloon counter pulsation or inotropic drugs 4. Preoperative kidney failure 5. Decompensated heart failure patients prior to surgery

Design outcomes

Primary

Measure	Time frame
A. To compare the hemodynamic effects and duration and dose of inotropic and vasopressor use with dexmedetomidine and midazolam with fentanyl during cardiac bypass. B. To compare the sedative effect of dexmedetomidine and midazolam with fentanyl during cardiopulmonary bypass. Timepoint: every 5 minutes during cardiac bypass, every 5 minutes post cardiac bypass inside OT, every hourly for 24 hours outside OT in CTVS ICU	—

Measure

Time frame

A. To compare the hemodynamic effects and duration and dose of inotropic and vasopressor use with dexmedetomidine and midazolam with fentanyl during cardiac bypass. B. To compare the sedative effect of dexmedetomidine and midazolam with fentanyl during cardiopulmonary bypass. Timepoint: every 5 minutes during cardiac bypass, every 5 minutes post cardiac bypass inside OT, every hourly for 24 hours outside OT in CTVS ICU

—

Secondary

Measure	Time frame
A. To compare the incidences of adverse events in dexmedetomidine and midazolam with fentanyl. B. To evaluate secondary outcomes which include renal failure, sepsis, delirium, postoperative ventilation hours, length of hospital stay, and 30-day readmission. Timepoint: 30 days	—

Countries

India

Contacts

Public Contactsunny aggarwal

North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences

aggarwalsunny87@gmail.com8259064008

Outcome results

None listed

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