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

NCT01895023 | Completed Phase 4

• 1 other identifier: FujianPH-TRC-130615
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Inhalational Anesthetics Adverse Reaction; Delirium on Emergence; Strabismus Following Ocular Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Postoperative vomiting

  up to 24 hours

Other Outcomes (3)

• Children's pain

  participants will be followed for the duration of PACU stay, an expected average of 1 hour

• Time of emergence

  up to 1 hour

• Duration of PACU stay

  participants will be followed for the duration of PACU stay, an expected average of 1 hour

Study Arms (3)

Dexmedetomidine group

EXPERIMENTAL

The dexmedetomidine group received intranasal dexmedetomidine 2mcg/kg premedication 45 min and oral saline 30 min before induction of anaesthesia

Drug: Dexmedetomidine

Midazolam group

ACTIVE COMPARATOR

The midazolam group received intranasal saline 45 min and oral midazolam 0.5 mg/kg 30 min before induction of anaesthesia.

Drug: Midazolam

Placebo Group

PLACEBO COMPARATOR

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

Drug: Saline

Interventions

Dexmedetomidine DRUG

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

Also known as: alpha2-adrenoceptor agonist

Dexmedetomidine group

Midazolam DRUG

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

Also known as: GABA modulators

Midazolam group

Saline DRUG

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

Also known as: sodium chloride injection (0.9%Nacl)

Placebo Group

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• aged2-6 yr, with American Society of Anesthesiologists physical status I or II, scheduled to undergo strabismus surgery during general anesthesia

You may not qualify if:

• mental disease, neurologic disease, treatment with sedatives, full stomach, or indication for rapid sequence induction.

Sponsors & Collaborators

• Yao Yusheng: lead
• West China Hospital: collaborator

Study Sites (1)

Fujian Provincial Hospital

Fuzhou, Fujian, 350001, China

Location

Related Publications (1)

• 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.

  PMID: 32976205 DERIVED

MeSH Terms

Conditions

Emergence Delirium

Interventions

Dexmedetomidine; Midazolam; GABA Modulators; Sodium Chloride

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; GABA Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Yusheng Yao, M.D.

  Fujian Provincial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 28, 2013
• First Posted: July 10, 2013
• Study Start: September 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: January 6, 2015

Record last verified: 2015-01

Locations

CN (1)