Dexmedetomidine use in pediatric strabismus surgery: A systematic review and meta-analysis.
Fu-Wei Chiang, Jin-Lin Chang, Shih-Chang Hsu...
https://pubmed.ncbi.nlm.nih.gov/33045022Actively Recruiting
Led by Alexandria University · Updated on 2026-04-13
120
Participants Needed
1
Research Sites
13 weeks
Total Duration
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
Effect of Intranasal Dexmedetomidine on the Incidence of Emergence Agitation in Children Undergoing Strabismus Surgery
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants receive intranasal dexmedetomidine 45 minutes before strabismus surgery under general anesthesia.
1 treatment visit (in-person)
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)
Total: 1 location
1
Alexandria University
Alexandria, Egypt
Actively Recruiting
S
sarah m elgamal, MD
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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Fu-Wei Chiang, Jin-Lin Chang, Shih-Chang Hsu...
https://pubmed.ncbi.nlm.nih.gov/33045022