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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Inhalational Anesthetics Adverse Reaction; Delirium on Emergence; Strabismus Following Ocular Surgery	Drug: Dexmedetomidine; Drug: Midazolam; Drug: Saline	Phase 4

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	156 participants
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
Study Start Date :	September 2013
Actual Primary Completion Date :	August 2014
Actual Study Completion Date :	August 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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)

Outcome Measures

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Primary Outcome Measures :

1. 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 :

1. 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:

1. 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.
2. Time of emergence [ Time Frame: up to 1 hour ]
   the time to the first response to a simple verbal command
3. 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.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 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