Effects of Dexmedetomidine on the Postoperative Experience in Children

Phase 4

Completed

• Conditions: Failed Moderate Sedation During Procedure
• Interventions: Drug: dexmedetomidine; Drug: Midazolam; Drug: fentanyl

• Registration Number: NCT01748630
• Lead Sponsor: Inonu University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2012-09
• Study Completion: 2012-10
• Study First Submitted: 2012-11-30
• Status Verified: 2012-12
• Study First Submitted QC: 2012-12-11
• Last Update Submitted: 2012-12-11
• Study First Posted: 2012-12-12
• Last Update Posted: 2012-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine, Midazolam	dexmedetomidine	dexmedetomidine (group DEX); starting dose, 0.4 μg•kg-1•h-1,with intermittent fentanyl
Midazolam	Midazolam	midazolam (group MDZ); starting dose, 0.1 mg•kg-1•h-1
Midazolam	fentanyl	midazolam (group MDZ); starting dose, 0.1 mg•kg-1•h-1
Dexmedetomidine, Midazolam	fentanyl	dexmedetomidine (group DEX); starting dose, 0.4 μg•kg-1•h-1,with intermittent fentanyl

Primary Outcome Measures

Name	Time	Method
fentanyl consumption	24 hours

Secondary Outcome Measures

Name	Time	Method
incidence of delirium	1, 2, 4 ,6 and 24 hours

Trial Locations

Locations (1)

Inonu University Turgut Ozal Medical Center; 🇹🇷 Malatya, Turkey