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Effects of Dexmedetomidine Premedication on Emergence Agitation After Strabismus Surgery in Children
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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 |
- 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.
- 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
- 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| Ages Eligible for Study: | 2 Years to 6 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01895023
| China, Fujian | |
| Fujian Provincial Hospital | |
| Fuzhou, Fujian, China, 350001 | |
| 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 |
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 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 Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adjuvants, Anesthesia |
ClinicalTrials.gov processed this record on August 23, 2017