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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03131375
Other study ID # Dexmedetomidine.1.2017
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date May 1, 2017
Est. completion date July 30, 2017

Study information

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

Clinical Trial Summary

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 .


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
Dexmedetomidine
Group A and B: Anesthesia induction drugs:propofol, fentanyl, rocuronium . After induction of anesthesia: Group A receives a 50 ml NS infusion containing 1 mcg kg-1 Dexmedetomidine drug Group A and B: Atropine as an antisialagogue, dexamethasone, ondasetrone for the prevention of postoperative nausea and vomiting. Anesthesia maintainance: propofol, remifentanil and oxygen in air. End of surgery, the infusion of propofol and remifentanil stop and sugammadex for reversal of neuromuscular block is given. Postoperative analgesia by nalbuphine 0.2 mg kg-1 given before the end of surgery in Group B, and 0.16 mg kg-1 in Group A. Monitoring: ECG, NIBP, ETCO2, SpO2, Bispectral index , Train of four ratio.
Normal saline
Group A and B: Anesthesia induction drugs:propofol, fentanyl, rocuronium . After induction of anesthesia: Group B receives a volume matched Normal saline infusion. Group A and B: Atropine as an antisialagogue, dexamethasone, ondasetrone for the prevention of postoperative nausea and vomiting. Anesthesia maintainance: propofol, remifentanil and oxygen in air. End of surgery, the infusion of propofol and remifentanil stop and sugammadex for reversal of neuromuscular block is given. Postoperative analgesia by nalbuphine 0.2 mg kg-1 given before the end of surgery in Group B. Monitoring: ECG, NIBP, ETCO2, SpO2, Bispectral index, Train of four ratio.
Device:
Bispectral index
Group A and B: Monitoring depth of anesthesia by BIS device and adjusting propofol infusion according to measurements, aiming to BIS values: 40-60
Train of four ratio
Group A and B: Monitoring recovery of neuromuscular function with TOF-Watch device, to ensure TOFR equals or greater than 90% at the end of the procedure

Locations

Country Name City State
Greece Childrens Hospital P. and A. Kyriakou Anesthesiology Department Athens

Sponsors (1)

Lead Sponsor Collaborator
Athens General Children's Hospital "Pan. & Aglaia Kyriakou"

Country where clinical trial is conducted

Greece, 

Outcome

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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