Actively Recruiting

Phase Not Applicable
Age: 3Years - 6Years
All Genders
ID07523438

Effect of Two Different Doses of Intranasal Dexmedetomidine on Emergence Agitation in Children Undergoing Strabismus Surgery A Randomized Clinical Trial

Led by Alexandria University · Updated on 2026-04-13

120

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to compare the effects of two different doses of intranasal dexmedetomidine on the incidence of emergence agitation in children undergoing strabismus surgery. Emergence agitation, or delirium, is a common problem in young patients after general anesthesia for eye muscle surgery, causing confusion, crying, and uncooperative behavior during recovery. This study focuses on children aged 3 to 6 years and investigates whether a higher dose of dexmedetomidine can reduce this agitation more than a lower dose. Participants are randomly assigned to receive either 3 mcg/kg or 2 mcg/kg of intranasal dexmedetomidine 45 minutes before surgery using a nasal atomizer device. The surgery is performed under general anesthesia with standard medications including sevoflurane and fentanyl. Monitoring during surgery includes blood pressure, heart rate, oxygen levels, and breathing. The study is double-blind and randomized, ensuring unbiased comparison between the two dose groups. During the study, children are assessed for emergence agitation using the Pediatric Anesthesia Emergence Delirium (PAED) scale. Other measures include heart rate and blood pressure changes during surgery, pain scores after surgery, anxiety before surgery using the Modified Yale Preoperative Anxiety Scale, and time spent in the post-anesthesia care unit. The study involves preoperative evaluation, careful monitoring during surgery, and follow-up after surgery to record these outcomes. Participation lasts through the surgery day and immediate recovery period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 3Years - 6Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 3 to 6 years, both sexes
  • ASA physical status class I or II
Not Eligible

You will not qualify if you...

  • History of neurological or psychiatric disease
  • Body mass index over 20 kg/m²
  • Allergy to dexmedetomidine
  • Current use of medications with sedative effects
  • Mentally retarded children unable to participate reliably in assessments or procedures

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Day of surgery

Participants receive intranasal dexmedetomidine 45 minutes before strabismus surgery under general anesthesia.

1 treatment visit (in-person)

Post-operative Follow-up

Duration - Up to postoperative day 1

Participants are monitored in the post-anesthesia care unit (PACU) for emergence agitation and other outcomes.

1 follow-up visit (in-person)

Trial Site Locations

Total: 1 location

1

Alexandria University

Alexandria, Egypt

Actively Recruiting

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Research Team

S

sarah m elgamal, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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