Dexmedetomidine Reduces Emergence Delirium in Children Undergoing Tonsillectomy With Propofol Anesthesia

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

Status and phase: Completed; Phase 3; Phase 2

Conditions: Postoperative Analgesia; Extubation Time; Emergence Delirium; Heart Rate; Blood Pressure

Treatments: Drug: Normal saline; Device: Bispectral index; Device: Train of four ratio; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT03131375

Dexmedetomidine.1.2017

Details and patient eligibility

About

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 .

Enrollment: 60 patients

Sex: All

Ages: 3 to 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Group A

Active Comparator group

Description:

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.

Treatment:

Drug: Dexmedetomidine

Device: Train of four ratio

Device: Bispectral index

Group B

Placebo Comparator group

Description:

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.

Treatment:

Device: Train of four ratio

Device: Bispectral index

Drug: Normal saline