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

Dexmedetomidine Versus Midazolam 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.

Study Overview

• Status: Completed
• Conditions: Delirium on Emergence; Inhalational Anesthetics Adverse Reaction; Strabismus Following Ocular Surgery
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Midazolam; Drug: Saline

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 Type: Interventional
• Enrollment (Actual): 156
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Fujian Provincial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 6 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: sodium chloride injection (0.9%Nacl)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emergence agitation	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.	participants will be followed for the duration of PACU stay, an expected average of 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative vomiting	Postoperative vomiting was assessed using a numeric rank score, where 0 = no vomiting,1 = vomited once, and 2 = vomited twice or more	up to 24 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Children's pain	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.	participants will be followed for the duration of PACU stay, an expected average of 1 hour
Time of emergence	the time to the first response to a simple verbal command	up to 1 hour
Duration of PACU stay	The subject was discharged from the PACU when they met the institutional guidelines of level of consciousness and comfort.	participants will be followed for the duration of PACU stay, an expected average of 1 hour

Collaborators and Investigators

• Sponsor: Yao Yusheng
• Collaborators: West China Hospital

Publications and helpful links

General Publications

• Yao Y, Sun Y, Lin J, Chen W, Lin Y, Zheng X. Intranasal dexmedetomidine versus oral midazolam premedication to prevent emergence delirium in children undergoing strabismus surgery: A randomised controlled trial. Eur J Anaesthesiol. 2020 Dec;37(12):1143-1149. doi: 10.1097/EJA.0000000000001270.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (ACTUAL): August 1, 2014
• Study Completion (ACTUAL): August 1, 2014

Study Registration Dates

• First Submitted: June 28, 2013
• First Submitted That Met QC Criteria: July 4, 2013
• First Posted (ESTIMATE): July 10, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): January 6, 2015
• Last Update Submitted That Met QC Criteria: January 2, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Eye Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Cranial Nerve Diseases; Ocular Motility Disorders; Delirium; Strabismus; Emergence Delirium; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Agents; Midazolam; Dexmedetomidine; GABA Modulators
• Other Study ID Numbers: FujianPH-TRC-130615