Dexmedetomidine Reduces Emergence Delirium in Children Undergoing Tonsillectomy With Propofol Anesthesia: a Prospective, Randomized, Double-blind, Single-center Study.
Overview
- Phase
- Phase 2
- Intervention
- Dexmedetomidine
- Conditions
- Emergence Delirium
- Sponsor
- Athens General Children's Hospital "Pan. & Aglaia Kyriakou"
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Emergence delirium in PACU
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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 .
Investigators
Adelais Tsiotou
Consultant of the Anesthesiology Dept, MD, PhD
Athens General Children's Hospital "Pan. & Aglaia Kyriakou"
Eligibility Criteria
Inclusion Criteria
- •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
Arms & Interventions
Group A
In Group A: Anesthesia induction drugs: propofol , fentanyl , rocuronium iv. After induction, Group A receives a 50 ml NS infusion containing the drug Dexmedetomidine 1 mcg kg-1 slowly. Anesthesia maintainance drugs: propofol and remifentanil. Reversal of neuromuscular block drugs: Sugammadex according to TOF measurements. Postoperative analgesia drugs: nalbuphine 0.16 mg kg-1 . Monitoring devices: ECG, NIBP , ETCO2, SpO2, Bispectral index, Train of four ratio.
Intervention: Dexmedetomidine
Group A
In Group A: Anesthesia induction drugs: propofol , fentanyl , rocuronium iv. After induction, Group A receives a 50 ml NS infusion containing the drug Dexmedetomidine 1 mcg kg-1 slowly. Anesthesia maintainance drugs: propofol and remifentanil. Reversal of neuromuscular block drugs: Sugammadex according to TOF measurements. Postoperative analgesia drugs: nalbuphine 0.16 mg kg-1 . Monitoring devices: ECG, NIBP , ETCO2, SpO2, Bispectral index, Train of four ratio.
Intervention: Bispectral index
Group A
In Group A: Anesthesia induction drugs: propofol , fentanyl , rocuronium iv. After induction, Group A receives a 50 ml NS infusion containing the drug Dexmedetomidine 1 mcg kg-1 slowly. Anesthesia maintainance drugs: propofol and remifentanil. Reversal of neuromuscular block drugs: Sugammadex according to TOF measurements. Postoperative analgesia drugs: nalbuphine 0.16 mg kg-1 . Monitoring devices: ECG, NIBP , ETCO2, SpO2, Bispectral index, Train of four ratio.
Intervention: Train of four ratio
Group B
In Group B: Anesthesia induction drugs: propofol , fentanyl , rocuronium iv. After induction, Group B receives a volume matched normal saline infusion slowly. Anesthesia maintainance drugs: propofol and remifentanil. Reversal of neuromuscular block drugs: Sugammadex according to TOF measurements. Postoperative analgesia drugs: nalbuphine 0.2 mg kg-1 . Monitoring devices: ECG, NIBP , ETCO2, SpO2, Bispectral index, Train of four ratio.
Intervention: Normal saline
Group B
In Group B: Anesthesia induction drugs: propofol , fentanyl , rocuronium iv. After induction, Group B receives a volume matched normal saline infusion slowly. Anesthesia maintainance drugs: propofol and remifentanil. Reversal of neuromuscular block drugs: Sugammadex according to TOF measurements. Postoperative analgesia drugs: nalbuphine 0.2 mg kg-1 . Monitoring devices: ECG, NIBP , ETCO2, SpO2, Bispectral index, Train of four ratio.
Intervention: Bispectral index
Group B
In Group B: Anesthesia induction drugs: propofol , fentanyl , rocuronium iv. After induction, Group B receives a volume matched normal saline infusion slowly. Anesthesia maintainance drugs: propofol and remifentanil. Reversal of neuromuscular block drugs: Sugammadex according to TOF measurements. Postoperative analgesia drugs: nalbuphine 0.2 mg kg-1 . Monitoring devices: ECG, NIBP , ETCO2, SpO2, Bispectral index, Train of four ratio.
Intervention: Train of four ratio
Outcomes
Primary Outcomes
Emergence delirium in PACU
Time Frame: up to 30 min
Presence or absence of Emergence delirium with and without dexmedetomidine assessed by Watcha scale
Secondary Outcomes
- Extubation time(up to15 min)
- Emergence delirium severity, assessed in PACU(up to 30 min)
- Heart rate(up to 45 min)
- Blood pressure(up to 45 min)