Effects of Dexmedetomidine on the Postoperative Experience in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr Mustafasaid, Inonu University
ClinicalTrials.gov Identifier:
NCT01748630
First received: November 30, 2012
Last updated: December 11, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Failed Moderate Sedation During Procedure
Drug: dexmedetomidine
Drug: Midazolam
Drug: fentanyl
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Pain, Fentanyl Consumption, and Delirium in Children After Scoliosis Surgery: Dexmedetomidine Versus Midazolam

Resource links provided by NLM:


Further study details as provided by Inonu University:

Primary Outcome Measures:
  • fentanyl consumption [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
  • fentanyl consumption [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]
  • fentanyl consumption [ Time Frame: 4 hours ] [ Designated as safety issue: Yes ]
  • fentanyl consumption [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
  • fentanyl consumption [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • incidence of delirium [ Time Frame: 1, 2, 4 ,6 and 24 hours ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • heart rate [ Time Frame: 1, 2, 4 ,6 and 24 hours ] [ Designated as safety issue: Yes ]

Enrollment: 42
Study Start Date: February 2012
Study Completion Date: October 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dexmedetomidine, Midazolam
dexmedetomidine (group DEX); starting dose, 0.4 μg•kg-1•h-1,with intermittent fentanyl
Drug: dexmedetomidine Drug: fentanyl
Active Comparator: Midazolam
midazolam (group MDZ); starting dose, 0.1 mg•kg-1•h-1
Drug: Midazolam Drug: fentanyl

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01748630

Locations
Turkey
Inonu University Turgut Ozal Medical Center
Malatya, Turkey, 44280
Sponsors and Collaborators
Inonu University
  More Information

No publications provided

Responsible Party: Dr Mustafasaid, Assist. Prof., Inonu University
ClinicalTrials.gov Identifier: NCT01748630     History of Changes
Other Study ID Numbers: TOTM_Anaesthesia_MSA1
Study First Received: November 30, 2012
Last Updated: December 11, 2012
Health Authority: Ministry of Health of Turkey General Directorate of Pharmaceuticals and Pharmacy: Turkey

Keywords provided by Inonu University:
scoliosis, sedation, children, fentanyl consumption, pain

Additional relevant MeSH terms:
Fentanyl
Midazolam
Dexmedetomidine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents

ClinicalTrials.gov processed this record on September 18, 2014