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NCT Number: NCT01895023

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

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.

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Key information

Conditions

Inhalational Anesthetics Adverse Reaction Confusion Delirium Delirium on Emergence Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Strabismus Following Ocular Surgery

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fujian Provincial Hospital

Fuzhou, Fujian, 350001, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

Drug

The dexmedetomidine group received intranasal dexmedetomidine 2mcg/kg premedication 45 min before induction of anaesthesia.

Other names: alpha2-adrenoceptor agonist

midazolam

Drug

The midazolam group oral midazolam 0.5 mg/kg 30 min before induction of anaesthesia.

Other names: GABA modulators

Saline

Drug

The Placebo group received intranasal saline premedication 45 min and oral saline 30 min before induction of anaesthesia

Other names: sodium chloride injection (0.9%Nacl)

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Yao Yusheng

Other

Collaborators

  • West China Hospital

Registry information

Official study title

Dexmedetomidine Versus Midazolam Premedication on Emergence Agitation After Strabismus Surgery in Children

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 10, 2013
Registry last updated
Jan 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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