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Effects of Dexmedetomidine on the Postoperative Experience in Children

NCT ID: NCT01748630

Last Updated: 2012-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-10-31

Brief Summary

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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

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Conditions

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Failed Moderate Sedation During Procedure

Keywords

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scoliosis, sedation, children, fentanyl consumption, pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dexmedetomidine, Midazolam

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

Group Type ACTIVE_COMPARATOR

dexmedetomidine

Intervention Type DRUG

fentanyl

Intervention Type DRUG

Midazolam

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

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

fentanyl

Intervention Type DRUG

Interventions

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dexmedetomidine

Intervention Type DRUG

Midazolam

Intervention Type DRUG

fentanyl

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Inonu University

OTHER

Sponsor Role lead

Responsible Party

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Dr Mustafasaid

Assist. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Inonu University Turgut Ozal Medical Center

Malatya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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TOTM_Anaesthesia_MSA1

Identifier Type: -

Identifier Source: org_study_id