Effects of Dexmedetomidine on the Postoperative Experience in Children

Inonu University

Status and phase: Completed; Phase 4

Conditions: Failed Moderate Sedation During Procedure

Treatments: Drug: dexmedetomidine; Drug: fentanyl; Drug: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT01748630

TOTM_Anaesthesia_MSA1

Details and patient eligibility

About

Background: The study aim was to compare the efficacy of dexmedetomidine versus midazolam for sedation during the early postoperative period in children who underwent scoliosis surgery.

Methods: We performed a prospective, randomized trial in an intensive care unit (ICU) in a tertiary care center. In this study, 42 patients (American Society of Anesthesiology physical status I and II) who underwent scoliosis surgery were divided into 2 groups according to sedation protocols: group DEX (n = 22) and group MDZ (n = 20). Children (12-18 years) requiring mechanical ventilation underwent a continuous infusion of either dexmedetomidine (group DEX; starting dose, 0.4 μg•kg-1•h-1) or midazolam (group MDZ; starting dose, 0.1 mg•kg-1•h-1) with intermittent fentanyl, as needed. The efficacy of sedation was assessed using the Richmond Agitation Sedation Scale (RASS). Quality of pain relief was measured using the Numeric Visual Analog Scale (NVAS). During the arousal assessment, delirium was determined in patients in the RASS range of -2 to +1 using the Confusion Assessment Method for the ICU (CAM-ICU). Fentanyl consumption, incidence of delirium, NVAS scores, and hemodynamics were recorded postoperatively at 2, 4, 6, and 24 h in the ICU.

Enrollment: 42 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

admittance to the ICU and a requirement of mechanical ventilation with an endotracheal tube.

Exclusion criteria

Patients who had a history of allergies to midazolam and/or dexmedetomidine; delirium, developmental delay, or mental retardation, as reported by parents; an American Society of Anesthesiologists classification greater than III; any known previous reactions to anesthesia; or a history of asthma or an anticipated difficult airway and concomitant disease (neuromuscular scoliosis or neurodegenerative disease) were excluded from the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups

Dexmedetomidine, Midazolam

Active Comparator group

Description:

dexmedetomidine (group DEX); starting dose, 0.4 μg•kg-1•h-1,with intermittent fentanyl

Treatment:

Drug: fentanyl

Drug: dexmedetomidine

Midazolam

Active Comparator group

Description:

midazolam (group MDZ); starting dose, 0.1 mg•kg-1•h-1

Treatment:

Drug: fentanyl

Drug: Midazolam