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NCT Number: NCT03131375

Dexmedetomidine Reduces Emergence Delirium in Children Undergoing Tonsillectomy With Propofol Anesthesia

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 .

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Key information

Conditions

Emergence Delirium Blood Pressure Confusion Delirium Extubation Time Heart Rate Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Analgesia Postoperative Complications Signs and Symptoms

Age range

3 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Childrens Hospital P. and A. Kyriakou Anesthesiology Department

Athens, 11526, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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.

Other names: alpha-2 agonist

normal saline

Drug

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.

Other names: placebo

Bispectral Index

Device

Group A and B: Monitoring depth of anesthesia by BIS device and adjusting propofol infusion according to measurements, aiming to BIS values: 40-60

Other names: BIS

Train of four ratio

Device

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

Other names: TOF-Watch

Primary outcomes

  1. 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

  1. Emergence delirium severity, assessed in PACU

    Time frame: up to 30 min

    Watcha score

  2. Extubation time

    Time frame: up to15 min

    time interval between discontinuation of anesthetics and extubation

  3. Heart rate

    Time frame: up to 45 min

    monitored intraoperatively ECG

  4. Blood pressure

    Time frame: up to 45 min

    monitored intraoperatively NIBP

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Dexmedetomidine Reduces Emergence Delirium in Children Undergoing Tonsillectomy With Propofol Anesthesia: a Prospective, Randomized, Double-blind, Single-center Study.

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 27, 2017
Registry last updated
Jul 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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