Emergence Delirium, Extubation Time, Heart Rate, Postoperative Analgesia, Blood Pressure
Conditions
Keywords
dexmedetomidine, emergence delirium, anesthesia, propofol, children
Brief 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 .
Interventions
DRUGDexmedetomidine
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.
DRUGNormal 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.
DEVICEBispectral 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
DEVICETrain 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
Sponsors
Athens General Children's Hospital Pan. & Aglaia Kyriakou
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 14 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emergence delirium in PACU | up to 30 min | Presence or absence of Emergence delirium with and without dexmedetomidine assessed by Watcha scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Emergence delirium severity, assessed in PACU | up to 30 min | Watcha score |
| Extubation time | up to15 min | time interval between discontinuation of anesthetics and extubation |
| Heart rate | up to 45 min | monitored intraoperatively ECG |
| Blood pressure | up to 45 min | monitored intraoperatively NIBP |
Countries
Greece
Outcome results
None listed