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BIS Monitoring of the Depth of Anaesthesia in Children

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ClinicalTrials.gov Identifier: NCT02664142
Recruitment Status : Completed
First Posted : January 26, 2016
Last Update Posted : March 23, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital Ostrava

Brief Summary:
General anaesthesia (GA) is, according to many definitions, the greatest gift presented to the medical art (S. B. Nuland). One of the aims of GA is to achieve the optimal depth of anaesthesia and rapid emergence from general anaesthesia. In order to achieve this goal, it is necessary to observe the clinical condition of the patient, and at the same time monitor the patient's overall condition. With the currently available options of GA management (e.g. use of intravenous anaesthetics, strong analgesics and modern volatile anaesthetics, in combination with various methods of topical anaesthesia) the importance of methods measuring the depth of GA increases. The depth of GA may be defined as a continuous progressive decreasing of the central nervous system, together with a decreased reactivity to stimuli. In the course of GA, perioperative awareness is detected in 0.1-0.2% of cases. Awakening during a surgical procedure may result in significant psychological complications (e.g. post-traumatic stress disorder), and the patient may suffer from a serious long-time disorder.

Condition or disease Intervention/treatment Phase
General Surgery Anaesthesia Procedure: BIS Group Procedure: Non-BIS Group Drug: Anaesthetics Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Monitoring the Depth of Anaesthesia in Children in the Course of a Surgical Procedure Using the BIS Monitor - Prospective Randomized Study
Actual Study Start Date : June 2015
Actual Primary Completion Date : September 2017
Actual Study Completion Date : November 2017

Arm Intervention/treatment
Experimental: BIS Group

BIS monitor will be used during the GA monitoring, the BIS value will be known to the anaesthetist (investigator)

  • GA induction (Phase 1):

    1. inhalation introduction (Sevorane, 02,AIR (flow 2:2 l/min)) or
    2. intra-venous introduction: (Suphentanil: (0.1-0.3 ug/kg iv.), Propofol (2-2,5 mg/kg iv.), or Mivacron (0.15-2mg/kg ),Tracrium (0.3-0.6mg/kg)
  • anaesthesia (Phase 2, Phase 3):

    1. hypnotic component: titration of Sevorane concentration, with the aim of achieving the BIS values of 40-60%, bearing gas mixture: O2/AIR (in proportion of 1:1, with 0.5:0.5 flows)
    2. analgesic component: Suphentanil (continuous dose of 0.1-0.3ug/kg iv. every 20-30 min)
    3. relaxation: Mivacron (continuous dose of 0.1mg/kg iv.), Tracrium(0.3-0.6 mg/kg) Patients in this group will be administered anaesthetic, in order to achieve and maintain the required general anaesthesia.
Procedure: BIS Group
BIS monitoring will be used in the BIS Group patients. The BIS value will be known to the anaesthetist, who will be able to act accordingly.

Drug: Anaesthetics
Anaesthetics will be administered in both experimental groups, in order to maintain the required general anaesthesia.

Experimental: Non-BIS Group

BIS monitor will be used during the GA monitoring, however the BIS value will not be known to the anaesthetist (investigator)

  • GA induction (Phase 1):

    1. inhalation introduction (Sevorane, 02,AIR (flow 2:2 l/min)) or
    2. intra-venous introduction: (Suphentanil: (0.1-0.3 ug/kg iv.), Propofol (2-2,5 mg/kg iv.), or Mivacron (0.15-2mg/kg ),Tracrium (0.3-0.6mg/kg)
  • anaesthesia (Phase 2, Phase 3):

    1. hypnotic component: titration of Sevorane concentration, with the aim of achieving the MAC value appropriate for the age of the child, bearing gas mixture: O2/AIR (in proportion of 1:1, with 0.5:0.5 flows)
    2. analgesic component: Suphentanil (continuous dose of 0.1-0.3ug/kg iv. every 20-30 min)
    3. relaxation: Mivacron (continuous dose of 0.1mg/kg iv.), Tracrium(0.3-0.6 mg/kg) Patients in this group will be administered anaesthetic, in order to achieve and maintain the required general anaesthesia.
Procedure: Non-BIS Group
BIS monitoring will be used in the Non-BIS Group patients. The BIS value will NOT be known to the anaesthetist and will be observed by a trained co-investigator, with subsequent evaluation.

Drug: Anaesthetics
Anaesthetics will be administered in both experimental groups, in order to maintain the required general anaesthesia.




Primary Outcome Measures :
  1. Occurrence of perioperative complications [ Time Frame: 24 months ]
    The occurrence of perioperative complications due to inappropriate depth of general anaesthesia will be observed.


Secondary Outcome Measures :
  1. Shortening of the emergence from general anaesthesia [ Time Frame: 24 months ]
    The time of emergence from general anaesthesia will be measured and compared in both groups.

  2. Decrease in the amount of inhalation anaesthetic used [ Time Frame: 24 months ]
    The decrease in the amount of inhalation anaesthetic used will be measured and compared in both groups.

  3. Decrease in the amount of analgesics used [ Time Frame: 24 months ]
    The decrease in the amount of analgesics used will be measured and compared in both groups.


Other Outcome Measures:
  1. Decrease of complications at recovery room [ Time Frame: 24 months ]
    The decrease in complications at recovery room will be measured and compared in both groups.



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Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • appropriate age
  • informed consent form signed by both parents (according to national legislation)
  • need to undergo a procedure in general anaesthesia
  • ASA I classification

Exclusion Criteria:

  • non-signing of the informed consent form by both parents
  • ASA classification higher than I

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): NCT02664142


Locations
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Czechia
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia, 70852
Sponsors and Collaborators
University Hospital Ostrava
Investigators
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Principal Investigator: Jan Divak, MD University Hospital Ostrava

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Responsible Party: University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT02664142     History of Changes
Other Study ID Numbers: FNO-KARIM-3
First Posted: January 26, 2016    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital Ostrava:
General Surgery
Child
Anaesthesia
Depth of anaesthesia
BIS monitoring
Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs