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Nurse-Led BIS-Guided Sedation Protocol in Pediatric Intensive Care

NCT07252024 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2025-11-26

No results posted yet for this study

Summary

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.

Conditions

  • Nurse's Role
  • Bispectral Index
  • Pediatric Sedation

Interventions

BEHAVIORAL

BIS-Guided Sedation Protocol

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.

Sponsors & Collaborators

  • Dr. Behcet Uz Children's Hospital

    lead OTHER

Principal Investigators

  • Hasan Agin, Prof.Dr. · Dr. Behcet Uz Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2025-07-01
Completion
2025-08-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07252024 on ClinicalTrials.gov