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Neuroprotective Effects of Dexmedetomidine in Pediatric Open-Heart Surgery with Cardiopulmonary Bypass: A Randomized Controlled Study Using Near-Infrared Spectroscopy and S-100B

Neuroprotective Effects of Dexmedetomidine in Pediatric Open-Heart Surgery with Cardiopulmonary Bypass: A Randomized Controlled Study Using Near-Infrared Spectroscopy and S-100B

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260317004
Enrollment
35
Registered
2026-03-17
Start date
2025-07-10
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Pediatric patients undergoing open heart surgery with cardiopulmonary bypass Dexmedetomidine Cardiopulmonary bypass Pediatric cardiac surgery Cerebral oxygenation S-100B Neuroprotection

Interventions

Dexmedetomidine 0.5 microgram per kg diluted in 5 mL of 0.9 percent sodium chloride was added to the cardiopulmonary bypass priming solution. This was followed by a continuous infusion of dexmedetomid
Experimental Drug,Placebo Comparator No treatment
Dexmedetomidine,Sodium Chloride 0.9%

Sponsors

Defitra Nanda Sasmita
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1. Pediatric patients scheduled to undergo open heart surgery aged 0 to 18 years. 2. Patients diagnosed with congenital heart disease requiring elective open heart surgery using cardiopulmonary bypass.

Exclusion criteria

Exclusion criteria: 1. Patients whose surgical plan changes from elective surgery to emergency surgery. 2. Patients with impaired liver function indicated by serum glutamic oxaloacetic transaminase or serum glutamic pyruvic transaminase levels more than 1.5 times the upper normal limit. 3. Patients with active infection before surgery. 4. Patients with impaired renal function indicated by serum creatinine levels above 2 mg per dL. 5. Patients with coagulation disorders indicated by international normalized ratio above 1.5. 6. Patients diagnosed with pre existing brain injury or neurological abnormalities before surgery.

Design outcomes

Primary

MeasureTime frame
Serum S-100B Before cardiopulmonary bypass and 6 to 12 hours after surgery Serum S 100B measured from venous blood using enzyme linked immunosorbent assay,cerebral oxygenation T0 after anesthesia induction before CPB, T1 CPB initiation, T2 aortic cross clamp, T3 60 minutes after CPB start, T4 5 minutes after CPB end, T5 30 minutes after CPB, T6 60 minutes after CPB Absolute regional cerebral oxygen saturation using near infrared spectroscopy

Secondary

MeasureTime frame
duration of mechanical ventilation since admission to cardiac intensive care unit until extubation number of days, cardiac intensive care unit length of stay since admission to cardiac intensive care unit until discharged number of days,7 day mortality 7 days after surgery Patient clinical status. Discharged to ward, Still on ventilator or Death

Countries

Indonesia

Contacts

Public ContactDefitra Sasmita

Faculty of Medicine, Universitas Indonesia

defitra.nanda@gmail.com813813701

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026