Pediatric intensive care sedation is traditionally based on subjective clinical scales. Bispectral Index (BIS) monitoring provides an objective EEG-based assessment of sedation depth. This prospective, two-center randomized controlled trial evaluates whether a nurse-led BIS-guided sedation protocol can reduce excessive or inadequate sedation, sedative medication exposure, withdrawal symptoms, and PICU length of stay in mechanically ventilated children.
This prospective, randomized (1:1) controlled trial was conducted in two tertiary PICUs in Turkey, including mechanically ventilated children aged 1 month to 18 years requiring continuous sedation. Patients were randomly assigned to: Intervention Group: Nurse-led sedation titration using BIS values (target: light sedation 60-80, deep sedation 45-60) combined with SBS scores under physician supervision. Nurses received structured theoretical and practical training before trial initiation. Control Group: Standard sedation protocol based solely on clinical sedation assessment without BIS-guided titration (BIS monitoring available but not used for titration). Primary Outcome: Percentage and duration of time spent outside the target BIS range Total sedative medication dose (mg/kg/day equivalents) Secondary Outcomes: PICU length of stay Mechanical ventilation duration Withdrawal symptoms (WAT-1 score) Results showed significantly reduced BIS out-of-target time, lower sedative drug exposure (midazolam, ketamine, dexmedetomidine), reduced withdrawal scores, and shorter PICU stay in the intervention group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
88
A structured sedation management protocol guided by Bispectral Index (BIS) monitoring and implemented by trained PICU nurses. The protocol includes BIS target ranges (light sedation 60-80; deep sedation 45-60), artifact recognition, standardized electrode placement, and stepwise titration of midazolam, ketamine, dexmedetomidine, or fentanyl according to predefined algorithms under physician supervision.
Behcet Uz Children's Hospital - Pediatric Intensive Care Unit
Izmir, Turkey (Türkiye)
Time Spent Outside BIS Target Range
otal duration (in hours) during which BIS values remain outside the predefined sedation targets (light sedation: 60-80; deep sedation: 45-60). This measure reflects adequacy of sedation and protocol effectiveness.
Time frame: First 72 hours of mechanical ventilation
Cumulative Midazolam Dose
otal midazolam dose administered (mg/kg) during mechanical ventilation.
Time frame: Up to 28 days or until extubation
Cumulative Ketamine Dose
Total ketamine dose administered (mcg/kg) during mechanical ventilation.
Time frame: Up to 28 days or until extubation
Cumulative Dexmedetomidine Dose
Total dexmedetomidine dose administered (mcg/kg) during mechanical ventilation.
Time frame: Up to 28 days or until extubation
Withdrawal Severity (WAT-1 Score)
Mean and peak WAT-1 scores assessed to determine iatrogenic withdrawal severity.
Time frame: First 7 days of PICU stay
PICU Length of Stay
Total number of days from PICU admission to PICU discharge.
Time frame: Up to 28 days
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