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Dexmedetomidine Reduces Emergence Delirium in Children Undergoing Tonsillectomy With Propofol Anesthesia

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ClinicalTrials.gov Identifier: NCT03131375
Recruitment Status : Completed
First Posted : April 27, 2017
Last Update Posted : July 9, 2018
Sponsor:
Information provided by (Responsible Party):
Adelais Tsiotou, Athens General Children's Hospital "Pan. & Aglaia Kyriakou"

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 .

Condition or disease Intervention/treatment Phase
Emergence Delirium Extubation Time Heart Rate Postoperative Analgesia Blood Pressure Drug: Dexmedetomidine Drug: Normal saline Device: Bispectral index Device: Train of four ratio Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Dexmedetomidine Reduces Emergence Delirium in Children Undergoing Tonsillectomy With Propofol Anesthesia: a Prospective, Randomized, Double-blind, Single-center Study.
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : July 30, 2017
Actual Study Completion Date : July 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium Tonsillitis

Arm Intervention/treatment
Active Comparator: 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.
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.
Other Name: alpha-2 agonist

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
Other Name: BIS

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
Other Name: TOF-Watch

Placebo Comparator: 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.
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.
Other Name: placebo

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
Other Name: BIS

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
Other Name: TOF-Watch




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   3 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03131375


Locations
Greece
Childrens Hospital P. and A. Kyriakou Anesthesiology Department
Athens, Greece, 11526
Sponsors and Collaborators
Athens General Children's Hospital "Pan. & Aglaia Kyriakou"
Investigators
Study Director: Evangelia Kalliardou, Consultant Director of the Anesthesiology Dept.

Responsible Party: Adelais Tsiotou, Consultant of the Anesthesiology Dept, MD, PhD, Athens General Children's Hospital "Pan. & Aglaia Kyriakou"
ClinicalTrials.gov Identifier: NCT03131375     History of Changes
Other Study ID Numbers: Dexmedetomidine.1.2017
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: July 9, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Adelais Tsiotou, Athens General Children's Hospital "Pan. & Aglaia Kyriakou":
dexmedetomidine
emergence delirium
anesthesia
propofol
children

Additional relevant MeSH terms:
Delirium
Emergence Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Postoperative Complications
Pathologic Processes
Anesthetics
Propofol
Fentanyl
Remifentanil
Dexmedetomidine
Nalbuphine
Rocuronium
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists