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Influence of Monitoring the Depth of General Anesthesia Upon the Incidence of PONV and Emergence Delirium in Children Undergoing Endoscopic Adenoidectomy in General Anesthesia

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ClinicalTrials.gov Identifier: NCT04466579
Recruitment Status : Not yet recruiting
First Posted : July 10, 2020
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital Ostrava

Brief Summary:
The study has been designed as a prospective randomized clinical trial. Due to the use of a bispectral (BIS) monitor in the interventional arm, the study will not be blinded for the anesthetist. The total planned number of study subjects is 100. Patients will be randomly randomized upon arrival to the operating theatre (using the envelope method) into the interventional arm (BIS monitoring of the depth of general anesthesia), and into the control group (standard management of general anesthesia to minimum alveolar concentration (MAC) 1,0). The target values of the depth of general anesthesia according to BIS are between 40 and 60.

Condition or disease Intervention/treatment Phase
Postoperative Nausea Postoperative Vomiting Emergence Delirium Other: BIS monitor Other: Standard care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study subjects will be randomized into two study arms.
Masking: None (Open Label)
Masking Description: No masking is being used in this study.
Primary Purpose: Diagnostic
Official Title: Influence of Monitoring the Depth of General Anesthesia Upon the Incidence of PONV and Emergence Delirium in Children Undergoing Endoscopic Adenoidectomy in General Anesthesia
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BIS monitoring
Study subjects randomized in this study arm will have the depth of anesthesia controlled with the BIS monitor.
Other: BIS monitor
BIS monitor is used to control and monitor the depth of general anesthesia.

Active Comparator: Standard care
Study subjects randomized in this study arm will receive standard anesthesiology care according to the usual procedures used at the study centre.
Other: Standard care
Standard anesthesiology care according to the protocol of the study




Primary Outcome Measures :
  1. Incidence of PONV [ Time Frame: During the hospitalisation of the patient, i.e. up to 5 days ]
    The incidence of PONV will be observed and recorded using the Baxter Reetching Faces (BARF) scale and recording the number of PONV episodes.

  2. Incidence of ED [ Time Frame: During the hospitalisation of the patient, i.e. up to 5 days ]
    The incidence of ED will be observed and recorded using the PAED score.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 3-8 years of age
  • Indication for the performance of endoscopic adenoidectomy in general anesthesia
  • ASA I a II
  • Consent of a parent/a guardian

Exclusion Criteria:

  • ASA III and more
  • Disapproval of a parent/a guardian
  • Disapproval of the patient
  • Allergies to medication used in the course of the study
  • Contraindication of inhalation introduction to anesthesia and the way of securing breathing passageways in the study, according to the attending anesthetist

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): NCT04466579


Contacts
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Contact: Petr Vávra, Ass.Prof.,MD,PhD 0042059737 ext 2544 petr.vavra@fno.cz
Contact: Jiří Hynčica 0042059737 ext 2587 jiri.hyncica@fno.cz

Locations
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Czechia
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia, 70852
Contact: Petr Vávra, Ass.Prof.,MD,PhD    0042059737 ext 2544    petr.vavra@fno.cz   
Contact: Jiří Hynčica    0042059737 ext 2587    jiri.hyncica@fno.cz   
Principal Investigator: Michal Frelich, MD,PhD         
Sub-Investigator: Jan Divák, MD,PhD         
Sub-Investigator: Vojtěch Vodička, MD,PhD         
Sub-Investigator: Filip Burša, MD,PhD         
Sub-Investigator: Martin Formánek, MD,PhD         
Sponsors and Collaborators
University Hospital Ostrava
Investigators
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Principal Investigator: Michal Frelich, MD,PhD University Hospital Ostrava
Publications:
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Responsible Party: University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT04466579    
Other Study ID Numbers: FNO-KARIM-14-PONV-ED
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The authors have no plan to make individual participant data available to other researchers. The data may be provided upon request.

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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 University Hospital Ostrava:
postoperative nausea
postoperative vomiting
emergence delirium
bispectral monitor
pediatric anesthesia
adenoidectomy
general anesthesia
Additional relevant MeSH terms:
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Delirium
Emergence Delirium
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Postoperative Complications
Pathologic Processes