NCT01748630

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 12, 2012

Completed
Last Updated

December 12, 2012

Status Verified

December 1, 2012

Enrollment Period

7 months

First QC Date

November 30, 2012

Last Update Submit

December 11, 2012

Conditions

Failed Moderate Sedation During Procedure

Keywords

scoliosis, sedation, children, fentanyl consumption, pain

Outcome Measures

Primary Outcomes (5)

  • fentanyl consumption

    1 hour

  • fentanyl consumption

    2 hours

  • fentanyl consumption

    4 hours

  • fentanyl consumption

    6 hours

  • fentanyl consumption

    24 hours

Secondary Outcomes (1)

  • incidence of delirium

    1, 2, 4 ,6 and 24 hours

Other Outcomes (1)

  • heart rate

    1, 2, 4 ,6 and 24 hours

Study Arms (2)

Dexmedetomidine, Midazolam

ACTIVE COMPARATOR

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

Drug: dexmedetomidineDrug: fentanyl

Midazolam

ACTIVE COMPARATOR

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

Drug: MidazolamDrug: fentanyl

Interventions

dexmedetomidineDRUG
Dexmedetomidine, Midazolam
MidazolamDRUG
Midazolam
fentanylDRUG
Dexmedetomidine, MidazolamMidazolam

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University Turgut Ozal Medical Center

Malatya, 44280, Turkey (Türkiye)

Location

MeSH Terms

Conditions

ScoliosisPain

Interventions

DexmedetomidineMidazolamFentanyl

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPiperidines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

November 30, 2012

First Posted

December 12, 2012

Study Start

February 1, 2012

Primary Completion

September 1, 2012

Study Completion

October 1, 2012

Last Updated

December 12, 2012

Record last verified: 2012-12

Locations

TU(1)