Effect of Intranasal Dexmedetomidine on the Incidence of Emergence Agitation in Children Undergoing Strabismus Surgery

NCT07523438 | Recruiting

• 1 other identifier: 0307780
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Dexmedetomidine is a selective a-2 adrenergic agonist that provides sedative and analgesic effects. Intranasal dexmedetomidine has a slower and gradual onset compared to intravenous injection , with low incidence of nasal discomfort. Dexmedetomidine was tested at various doses and modes of administration, as well as different types of surgery and co-anesthetic drugs, as a single injection or continuous infusion. The authors have not agreed on the ideal clinical dose. The hypothesis is that intranasal dexmedetomidine 3mcg /kg will decrease the incidence of emergence agitation after strabismus surgery than dexmedetomidine 2 mcg/kg

Conditions

Dexmedetomidine; Emergence Agitation

Keywords

Dexmedetomidine; emergence agitation; strabismus surgery

Outcome Measures

Primary Outcomes (1)

• Incidence of emergence agitation

  pediatric anesthesia emergence delirium ( PAED) scale.

  postoperative day 1

Secondary Outcomes (3)

• Incidence of intraoperative hemodynamic changes

  postoperative day 1

• Modified Yale Preoperative Anxiety Scale (mYPAS) upon separation from parents

  postoperative day1

• PACU discharge time

  postoperative day 1

Study Arms (2)

high dex group

OTHER

patients will receive 3 mcg/kg intranasal dexmedetomidine 45minutes before surgery

Other: high dex group

low dex group

OTHER

patients will receive 2 mcg/kg intranasal dexmedetomidine 45minutes before surgery

Other: low dex group

Interventions

high dex group OTHER

patients will receive 3 mcg/kg intranasal dexmedetomidine 45minutes before surgery

Also known as: group 1

high dex group

low dex group OTHER

patients will receive 2 mcg/kg intranasal dexmedetomidine 45minutes before surgery

Also known as: group 2

low dex group

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age: 3-6 years, both sexes
• ASA physical status class I , II.

You may not qualify if:

• history of neurological and psychiatric disease
• body mass index \> 20 kg m-2
• allergy to dexmedetomidine
• patients on medical treatment which has any sedative effect
• mentally retarded children

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University

Alexandria, Egypt

RECRUITING

Related Publications (1)

• Chiang FW, Chang JL, Hsu SC, Hsu KY, Chu KC, Huang CJ, Bai CH, Chen C, Hsu CW, Hsu YP. Dexmedetomidine use in pediatric strabismus surgery: A systematic review and meta-analysis. PLoS One. 2020 Oct 12;15(10):e0240553. doi: 10.1371/journal.pone.0240553. eCollection 2020.

  PMID: 33045022 BACKGROUND

MeSH Terms

Conditions

Emergence Delirium

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

Study Officials

• sarah m elgamal, MD

  Alexandria University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

sarah m elgamal, MD

CONTACT

01005496440; sarahelgamal1990@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: April 5, 2026
• First Posted: April 13, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)