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Dexmetomidine in Children Undergoing General Anaesthesia

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ClinicalTrials.gov Identifier: NCT03923075
Recruitment Status : Not yet recruiting
First Posted : April 22, 2019
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Paraskevi Matsota, Attikon Hospital

Brief Summary:
The effects of dexmedetomidine on the onset of both the general anaesthesia induction and the neuromuscular blockade in children of school age will be investigated. Ten minutes before the induction of general anaesthesia, the first group will receive continuous infusion of dexmedetomidine (DEX group), while the second group will receive normal saline (Placebo group).

Condition or disease Intervention/treatment Phase
Anesthesia Drug: Dexmedetomidine Other: 0.9% saline Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: The Effects of Dexmedetomidine on Induction of Anaesthesia and Onset of Neuromuscular Blockade in Children
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Dexmedetomidine

Drug: dexmedetomidine (Dexmed) solution(100μcg of dexmedetomidine in 50ml N/S 0.9%). given at a bolus dose of 0.5μcg/kg of the dexmedetomidine solution [that corresponds to the volume (ml) calculated by the type "body weight (Kg)/4 or body weight (Kg) X 0.25".

THE SOLUTION IS GIVEN AS CONTINUOUS INFUSION 10 MINUTES BEFORE THE INDUCTION OF GENERAL ANAESTHESIA IN CHILDREN UNDERGOING ELECTIVE SURGERY

Drug: Dexmedetomidine
INFUSION BEFORE INDUCTION OF ANAESTHESIA
Other Name: Dexmed

Placebo Comparator: 0.9 % saline
Drug:0.9 % saline solution (Normal saline) given at a volume (ml) determined by the type: "body weight (Kg)/4 or body weight (Kg) X 0.25" THE SOLUTION IS GIVEN AS CONTINUOUS INFUSION 10 MINUTES BEFORE THE INDUCTION OF GENERAL ANAESTHESIA IN CHILDREN UNDERGOING ELECTIVE SURGERY
Other: 0.9% saline
INFUSION BEFORE INDUCTION OF ANAESTHESIA
Other Name: normal saline




Primary Outcome Measures :
  1. Onset of neuromuscular blockade [ Time Frame: Up to 5 minutes after the injection of rocuronium ]
    Neuromuscular blockade is estimated with TOF acceleromyography, while onset of neuromuscular blockaded is defined as the time needed to achieve TOF=0 after the injection of rocuronium.


Secondary Outcome Measures :
  1. Onset of anaesthesia induction [ Time Frame: Up to 15 minutes after the initiation of the infusion of dexmedemoditine or normal saline, respectively ]
    The depth of anaesthesia is monitored using the BIS device (range 0-100). Onset of anesthesia is defined as the time needed to achieve BIS value<60, after the injection of propofol.

  2. Number of participants who developed bradycardia [ Time Frame: Up to 30 minutes after the initiation of the infusion of dexmedemoditine or normal saline, respectively ]
    Bradycardia is defined as >20% reduction of HR from the baseline values or as HR<60bpm using ECG monitoring.

  3. Number of participants who developed hypotension [ Time Frame: Up to 30 minutes after the initiation of the infusion of dexmedemoditine or normal saline, respectively ]
    Hypotension is defined as >20mmHg reduction of SAP from the baseline values using noninvasive monitoring of arterial pressure



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Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children underoing elective surgery under general anaesthsia
  • age 4-12 years old
  • ASA I-II

Exclusion Criteria:

  • patient or parent refusal
  • Mallampati score> 3
  • BMI>35
  • severe systemic cardiac disease
  • neuromuscular disease
  • recent respiratory infection
  • drug allergy

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): NCT03923075


Contacts
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Contact: Paraskevi K Matsota, Assoc Prof 6945544563 matsota@yahoo.gr
Contact: Paraskevi K Matsota 6945544563 matsota@yahoo.gr

Locations
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Greece
2nd Department of Anesthesiology, Attikon University Hospital
Athens, Attiki, Greece, 12462
Sponsors and Collaborators
Attikon Hospital
Investigators
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Study Chair: Georgia K Kostopanagiotou 2nd Department of Anaesthesiology, "Attikon" University Hospital
Principal Investigator: Paraskevi K Matsota 2nd Department of Anaesthesiology, "Attikon" University Hospital

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Responsible Party: Paraskevi Matsota, Assoc Prof of Anaesthesiology, Attikon Hospital
ClinicalTrials.gov Identifier: NCT03923075     History of Changes
Other Study ID Numbers: DEXAINMBCH
First Posted: April 22, 2019    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: restrictions due to regulation for personal data protection

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Paraskevi Matsota, Attikon Hospital:
dexmedetomidine
propofol
rocuronium
TOF
children

Additional relevant MeSH terms:
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Anesthetics
Dexmedetomidine
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action