Blood Pressure Clinical Trial
Official title:
Dexmedetomidine Reduces Emergence Delirium in Children Undergoing Tonsillectomy With Propofol Anesthesia: a Prospective, Randomized, Double-blind, Single-center Study.
Verified date | July 2018 |
Source | Athens General Children's Hospital "Pan. & Aglaia Kyriakou" |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Dexmedetomidine (DEX) is safe and effective in reducing ED following sevoflurane anesthesia. The investigators intend to study the efficacy of DEX in reducing ED in children undergoing tonsillectomy with and without adenoidectomy using total intravenous anesthesia (TIVA) with propofol .
Status | Completed |
Enrollment | 60 |
Est. completion date | July 30, 2017 |
Est. primary completion date | July 30, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 14 Years |
Eligibility |
Inclusion Criteria: - Children - ASA I or II - tonsillectomy with or without adenoidectomy Exclusion Criteria: - Allergy to dexmedetomidine - Allergy to anesthetic drugs - History of neurological disease - History of neuromuscular disease - History of renal disease - History of hepatic disease - craniofacial anomalies - History of cardiac disease - History of respiratory disease |
Country | Name | City | State |
---|---|---|---|
Greece | Childrens Hospital P. and A. Kyriakou Anesthesiology Department | Athens |
Lead Sponsor | Collaborator |
---|---|
Athens General Children's Hospital "Pan. & Aglaia Kyriakou" |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Emergence delirium in PACU | Presence or absence of Emergence delirium with and without dexmedetomidine assessed by Watcha scale | up to 30 min | |
Secondary | Emergence delirium severity, assessed in PACU | Watcha score | up to 30 min | |
Secondary | Extubation time | time interval between discontinuation of anesthetics and extubation | up to15 min | |
Secondary | Heart rate | monitored intraoperatively ECG | up to 45 min | |
Secondary | Blood pressure | monitored intraoperatively NIBP | up to 45 min |
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