Dexmedetomidine Reduces Emergence Delirium in Children Undergoing Tonsillectomy With Propofol Anesthesia

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 .

Conditions

• Emergence Delirium
• Extubation Time
• Heart Rate
• Postoperative Analgesia
• Blood Pressure

Interventions

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.

DRUG

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

DEVICE

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

Sponsors & Collaborators

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

  lead OTHER

Principal Investigators

• Evangelia Kalliardou, Consultant · Director of the Anesthesiology Dept.

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

14 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-05-01

Primary Completion

2017-07-30

Completion

2017-07-30

Countries

• Greece

Study Locations