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Effects of Dexmedetomidine Premedication on Emergence Agitation After Strabismus Surgery in Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01895023
First Posted: July 10, 2013
Last Update Posted: January 6, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
West China Hospital
Information provided by (Responsible Party):
Yao Yusheng, Fujian Provincial Hospital
  Purpose

Sevoflurane is frequently used for pediatric anesthesia because it has low pungency and rapid onset and offset of action.The reported incidence of emergence agitation (EA) following sevoflurane anesthesia varies from 10-80%. Despite its spontaneous resolution, EA is still considered as a potentially serious complication because of the risks of self-injury, and because of the stress caused to both caregivers and families.

Dexmedetomidine, an Alpha2-adrenoceptor agonist with sedative, analgesic, and anxiolytic actions, has been used in pediatric populations.Several prospective clinical trials in children have shown that dexmedetomidine significantly reduces the incidence of EA prior to recovery from sevoflurane anesthesia. However, the effect of dexmedetomidine premedication on emergence agitation has not been fully evaluated. The purpose of the present study was to verify the hypothesis that intranasal premedication with dexmedetomidine is effective in reducing emergence agitation after sevoflurane anaesthesia.


Condition Intervention Phase
Inhalational Anesthetics Adverse Reaction Delirium on Emergence Strabismus Following Ocular Surgery Drug: Dexmedetomidine Drug: Midazolam Drug: Saline Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Dexmedetomidine Versus Midazolam Premedication on Emergence Agitation After Strabismus Surgery in Children

Resource links provided by NLM:


Further study details as provided by Yao Yusheng, Fujian Provincial Hospital:

Primary Outcome Measures:
  • Emergence agitation [ Time Frame: participants will be followed for the duration of PACU stay, an expected average of 1 hour ]

    Emergence agitation was assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale.The PEAD scale contains five items (eye contact, purposefulness of actions,awareness of surroundings, restlessness and consolability), each scored on a 0 to 4 scale, for a maximum of 20 points.

    A perfectly calm child scores 0 and extreme agitation corresponds to 20 points. The peak EA score was recorded. scores>= 10 were regarded as presence of agitation.



Secondary Outcome Measures:
  • Postoperative vomiting [ Time Frame: up to 24 hours ]
    Postoperative vomiting was assessed using a numeric rank score, where 0 = no vomiting,1 = vomited once, and 2 = vomited twice or more


Other Outcome Measures:
  • Children's pain [ Time Frame: participants will be followed for the duration of PACU stay, an expected average of 1 hour ]
    A Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) was used to measure five categories of pain related behaviour, each scored from 0, 1 or 2, for a maximum score of 10.

  • Time of emergence [ Time Frame: up to 1 hour ]
    the time to the first response to a simple verbal command

  • Duration of PACU stay [ Time Frame: participants will be followed for the duration of PACU stay, an expected average of 1 hour ]
    The subject was discharged from the PACU when they met the institutional guidelines of level of consciousness and comfort.


Enrollment: 156
Study Start Date: September 2013
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexmedetomidine group
The dexmedetomidine group received intranasal dexmedetomidine 2mcg/kg premedication 45 min and oral saline 30 min before induction of anaesthesia
Drug: Dexmedetomidine
The dexmedetomidine group received intranasal dexmedetomidine 2mcg/kg premedication 45 min before induction of anaesthesia.
Other Name: alpha2-adrenoceptor agonist
Active Comparator: Midazolam group
The midazolam group received intranasal saline 45 min and oral midazolam 0.5 mg/kg 30 min before induction of anaesthesia.
Drug: Midazolam
The midazolam group oral midazolam 0.5 mg/kg 30 min before induction of anaesthesia.
Other Name: GABA modulators
Placebo Comparator: Placebo Group
The Placebo group received intranasal saline premedication 45 min and oral saline 30 min before induction of anaesthesia
Drug: Saline
The Placebo group received intranasal saline premedication 45 min and oral saline 30 min before induction of anaesthesia
Other Name: sodium chloride injection (0.9%Nacl)

Detailed Description:

Emergence agitation was assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale.The PAED scale contains five items (eye contact, purposefulness of actions,awareness of surroundings, restlessness and consolability), each scored on a 0 to 4 scale, for a maximum of 20 points.

A perfectly calm child scores 0 and extreme agitation corresponds to 20 points. The peak EA score was recorded. Agitation scores < 10 were interpreted as an absence of agitation, scores>= 10 were regarded as presence of agitation.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • aged2-6 yr, with American Society of Anesthesiologists physical status I or II, scheduled to undergo strabismus surgery during general anesthesia

Exclusion Criteria:

  • mental disease, neurologic disease, treatment with sedatives, full stomach, or indication for rapid sequence induction.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01895023


Locations
China, Fujian
Fujian Provincial Hospital
Fuzhou, Fujian, China, 350001
Sponsors and Collaborators
Yao Yusheng
West China Hospital
Investigators
Principal Investigator: Yusheng Yao, M.D. Fujian Provincial Hospital
  More Information

Responsible Party: Yao Yusheng, Dr., Fujian Provincial Hospital
ClinicalTrials.gov Identifier: NCT01895023     History of Changes
Other Study ID Numbers: FujianPH-TRC-130615
First Submitted: June 28, 2013
First Posted: July 10, 2013
Last Update Posted: January 6, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Delirium
Strabismus
Emergence Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Ocular Motility Disorders
Cranial Nerve Diseases
Eye Diseases
Postoperative Complications
Pathologic Processes
Anesthetics
Midazolam
Dexmedetomidine
GABA Modulators
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents