Correlation Between Sedation Depth Monitoring and Reflexes During Intravenous Anesthesia With Dexmedetomidine and Remifentanil in Children Undergoing Direct Laryngoscopy for Surgical Procedures

January 20, 2025 updated by: Joke De Wachter, University Hospital, Antwerp
This study evaluates the correlation between sedation depth monitoring obtained by NeuroSENSE ® NS 701 Monitor and reflexes during intravenous anesthesia in children undergoing direct laryngoscopy for surgical procedures.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Direct laryngoscopy for invasive procedures in children is performed under general anesthesia with spontaneous or controlled ventilation.Preventing under-or over-sedation and titration of sedation according to patient needs with spontaneous ventilation is a real challenge. It is common practice that dexmedetomidine and remifentanil are titrated based on the evaluation of respiratory clinical signs (cough, spasm, movement) and immobility of the vocal cords.NeuroSENSE ®NS 701 Monitor( NeuroWave Systems incorporated - Cleveland Heights,OH) is a sedation depth monitor that uses automated electroencephalogram quantification. It provides information about depth of anesthesia before change of clinical signs.The primary reason for WAVCNS monitoring is to prevent under-or over-sedation, to titrate sedation according to patient needs. NeuroSENSE ® is validated for monitoring sedation depth in adults but not in children. The Wavelet-based Anesthetic Value for Central Venous System (WAVCNS) index calculated by this monitor is scaled into the 100-0 range, where 100 denotes a brain state consistent with an awake patient and a 0 denotes a total and prolonged absence of cortical activity. The recommended WAVCNS index range for general anesthesia is between 40-60 as within this range there is very low probability of a patient being either awake or in deep anesthetic state. The validated use of a sedation depth monitor in children, who are at risk for medication overdosage or airway spasm by underdosing sedatives, could be a major advantage. In this trial ten children scheduled for direct laryngoscopy with surgical intervention will be enrolled after obtaining written informed consent of their parents or legal guardian.The NeuroSENSE ®monitor will be installed previous to anesthesia induction. The attending anesthesiologist is instructed to guide titration of dexmedetomidine/ remifentanil according to clinical signs, which is standard of care. He is blinded for the NeuroSENSE ® monitor.Induction of anesthesia will be done with sevoflurane an a bolus of dexmedetomidine 4 microgram/kilogram will be administered. Maintenance of anesthesia will be accomplished with dexmedetomidine infused at 2 microgram/kilogram/hour and adjusted to clinical needs with top up bolus dexmedetomidine of 0.5 microgram/kg/hour. Remifentanil will be infused at 0.3 mcg/kg/min and adjusted to clinical needs to 0.5 mcg/kg/min. Before start of surgery, on visualising the vocal cords 1 spray of 10 percent lidocaine is delivered to anesthetize the vocal cords. all children receive pharyngeal tube for oxygen supplementation. Spontaneous ventilation will be maintained. In case of laryngospasm and desaturation, propofol will be used as rescue medication. After surgery all children will be monitored on Intensive Care or Post Anesthetic Care Unit as standard of care. Heart rate, non-invasive blood pressure, pulse oxygen saturation, respiratory rate will be recorded at Innovian (Drager Medical Systems, Andover, USA) Induction time, adverse events, incidence of leg movements during anesthesia, cough, postoperative awakening and recovery time will be assessed.Surgery satisfaction will be assessed using score 1 is extremely dissatisfied; 2 is not satisfied but able to manage; 3 is extremely satisfied. At end of surgery total cumulative dose of dexmedetomidine and remifentanil will be calculated. Results from NeuroSENSE ® are extracted as raw data from the device.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
    • Antwerp
      • Edegem, Antwerp, Belgium, 2650
        • Recruiting
        • University Hospital Antwerp
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 month to 8 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

children scheduled for direct laryngoscopy with surgical intervention

Description

Inclusion Criteria:

scheduled for elective direct laryngoscopy with surgical intervention, written informed consent of their parents or legal guardian.

Exclusion Criteria:

refusal of informed consent, known allergy for dexmedetomidine or remifentanil at start of anesthesia pulse oxygen saturation (SaO2) lower than 85%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Reliability of NeuroSENSE ®in children
Children scheduled for direct laryngoscopy with surgical intervention the reliability of NeuroSENSE ®monitoring will be evaluated
Device: NeuroSENSE ®in children
Before induction of anesthesia NeuroSENSE ® monitoring will be applied to all subjects.General anesthesia with dexmedetomidine and remifentanil is titrated based on the evaluation of respiratory clinical signs (cough, spasm, movement) and immobility of the vocal cords. The anesthesiologist performing anesthesia will be blinded for the Wavelet-based Anesthetic Value for Central Venous System (WAVCNS) index assessed by NeuroSENSE ® and will adjust dexmedetomidine according to clinical signs, which is standard of care. Retrospectively data obtained by NeuroSENSE ® will be compared to evaluate whether they are useful in predicting upcoming unwanted airway reflexes.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
predictability of NeuroSENSE ® in upcoming unwanted airway reflexes
Time Frame: during surgery
Define whether the NeuroSENSE ® provides information before upcoming clinical signs about under- or over-sedation defined as cough, laryngospasm, apnea or desaturation
during surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of leg movement
Time Frame: During surgery
Incidence of any lower limb movement during anesthesia
During surgery
Total cumulative dose of dexmedetomidine
Time Frame: From induction of anesthesia till extubation with a maximum up to 4 hours after intubation
Total dose of dexmedetomidine during anesthesia in microgram
From induction of anesthesia till extubation with a maximum up to 4 hours after intubation
Total cumulative dose of remifentanil
Time Frame: From induction of anesthesia till extubation with a maximum up to 4 hours after intubation
Total dose of remifentanil during anesthesia in microgram
From induction of anesthesia till extubation with a maximum up to 4 hours after intubation
Postoperative awaking time
Time Frame: Time between end of surgery and opening of the eyes in minutes, up to a maximum of 30 minutes
Time between end of surgery and addressability of the patient in minutes
Time between end of surgery and opening of the eyes in minutes, up to a maximum of 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Antwerp

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Vera Saldien, University Hospital, Antwerp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 23, 2017

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17/31/360

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Child

Clinical Trials on NeuroSENSE ®in children

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings