Effects of Dexmedetomidine on the Postoperative Experience in Children
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 ]
- incidence of delirium [ Time Frame: 1, 2, 4 ,6 and 24 hours ] [ Designated as safety issue: No ]
- 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 |
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 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:
|
Midazolam Fentanyl Dexmedetomidine Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General |
Anesthetics GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Narcotics Analgesics Sensory System Agents Peripheral Nervous System Agents Analgesics, Opioid Analgesics, Non-Narcotic Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents |
ClinicalTrials.gov processed this record on May 19, 2013