Effects of Dexmedetomidine Premedication on Emergence Agitation After Strabismus Surgery in Children - Full Text View

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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:

Drug Information available for: Midazolam maleate Midazolam hydrochloride Dexmedetomidine Dexmedetomidine hydrochloride

Genetic and Rare Diseases Information Center resources: Ocular Motility Disorders Motor Neuro-ophthalmic Disorders

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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


Ages Eligible for Study:	2 Years to 6 Years (Child)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	June 28, 2013
Last Updated:	January 2, 2015
Health Authority:	China: Ethics Committee

Additional relevant MeSH terms:


Delirium Strabismus Confusion Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms Neurocognitive Disorders Mental Disorders Ocular Motility Disorders Cranial Nerve Diseases Eye Diseases Anesthetics Midazolam Dexmedetomidine	GABA Modulators Central Nervous System Depressants Physiological Effects of Drugs Adjuvants, Anesthesia Hypnotics and Sedatives Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs Anesthetics, Intravenous Anesthetics, General GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics, Non-Narcotic Analgesics

ClinicalTrials.gov processed this record on September 30, 2016