NCT02043938

Brief Summary

This is an interventional, randomized controlled study in health volunteers that involves collecting data on raw EEG waves measuring various combinations of anesthetic drugs during standardized drug titration.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 16, 2013

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 23, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2015

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

May 2, 2018

Completed
Last Updated

May 2, 2018

Status Verified

March 1, 2018

Enrollment Period

1.5 years

First QC Date

January 9, 2014

Results QC Date

August 21, 2017

Last Update Submit

March 30, 2018

Conditions

Anesthesia

Keywords

Electroencephalographypharmacological

Outcome Measures

Primary Outcomes (1)

  • Patient State Index (PSI) Comparison, Baseline and Emax

    Patient State Index (PSI-1) is a processed EEG parameter that quantifies the level of EEG inhibition. A new algorithm (PSI-2) has been created to improve performance in low power EEG. PSI is unitless. It ranges between 100 and 0 (100 representing 'awake state', 0 denoting 'no detectable electrical brain activity'). PSI-1 and PSI-2 were compared in their correlation with measured propofol and sevoflurane concentrations with or without remifentanil (0, 2 ,or 4 ng/mL) via several estimated PD model parameters. In the data table, BL (Baseline) denotes PSI-2 measurements when no drug is present; Emax denotes PSI in the presence of the maximum drug effect; C50 is the drug concentration which produces 50% of the maximal drug effect (ug/mL for Propofol C50, vol% for Sevoflurane C50).

    6 weeks

Other Outcomes (3)

  • Patient State Index (PSI) Comparison, C50 (Sevoflurane, Sevoflurane+Remifentanil)

    6 weeks

  • Patient State Index (PSI) Comparison, C50 (Propofol, Propofol+Remifentanil)

    6 weeks

  • Propofol, Sevoflurane, and Remifentanil Interaction.

    6 weeks

Study Arms (1)

Healthy Volunteers

EXPERIMENTAL

All healthy volunteers will receive four sessions of anesthesia with different common drug combinations while having SedLine EEG sensors placed on their forehead during these sessions to study the effects of these drugs on the brain. The sessions were: propofol (P), sevoflurane (S), propofol with remifentanil (PR), and sevoflurane with remifentanil (SR).

Device: SedLine EEG sensor

Interventions

SedLine EEG sensorDEVICE

Test subjects in each group will receive the same device intervention (SedLine EEG) to monitor their EEG waves.

Healthy Volunteers

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers aged 18 to 70 years
  • Concerning the cognitive function: Volunteers are considered to have sufficient cognitive reserve if they are able to read and comprehend the patient information form, if they can adequately answer the anamnestic questions during the screening process and if they are allowed to provide legitimate written informed consent
  • No selection will be made regarding ethnic background.
  • For this study no control group has been selected as EEG is compared between episodes rather than between individuals (each volunteer is his/her own control)

You may not qualify if:

  • Volunteer refusal
  • Volunteer \< 18 years and \>70 years
  • Pregnancy
  • Neurological disorder (epilepsy, the presence of a brain tumor, a history of brain surgery, hydrocephalic disorders, depression needing treatment with anti-depressive drugs, a history of brain trauma, a subarachnoidal bleeding, TIA or cerebral infarct, psychosis or dementia , schizophrenia, alcohol or drug abuse).
  • Diseases involving the cardiovascular system (hypertension, coronary artery disease, prior acute myocardial infarction, any valvular and/or myocardial disease involving decrease in ejection fraction, arrhythmias, which are either symptomatic or require continuous medication/pacemaker/automatic internal cardioverter defibrillator
  • Pulmonary Diseases
  • Gastric Diseases
  • Endocrinologic diseases
  • Recent use of psycho-active medication (benzodiazepines, anti-epileptic drugs, parkinson medication, anti-depressant drugs, opioids) or more than 20g of alcohol daily

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, 9713EZ, Netherlands

Location

Related Publications (5)

  • Su H, Koomen JV, Eleveld DJ, Struys MMRF, Colin PJ. Pharmacodynamic mechanism-based interaction model for the haemodynamic effects of remifentanil and propofol in healthy volunteers. Br J Anaesth. 2023 Aug;131(2):222-233. doi: 10.1016/j.bja.2023.04.043. Epub 2023 Jun 22.

    PMID: 37355412DERIVED

  • Su H, Eleveld DJ, Struys MMRF, Colin PJ. Mechanism-based pharmacodynamic model for propofol haemodynamic effects in healthy volunteers☆. Br J Anaesth. 2022 May;128(5):806-816. doi: 10.1016/j.bja.2022.01.022. Epub 2022 Mar 3.

    PMID: 35249706DERIVED

  • Ramaswamy SM, Kuizenga MH, Weerink MAS, Vereecke HEM, Struys MMRF, Belur Nagaraj S. Frontal electroencephalogram based drug, sex, and age independent sedation level prediction using non-linear machine learning algorithms. J Clin Monit Comput. 2022 Feb;36(1):121-130. doi: 10.1007/s10877-020-00627-3. Epub 2020 Dec 14.

    PMID: 33315176DERIVED

  • Ramaswamy SM, Kuizenga MH, Weerink MAS, Vereecke HEM, Struys MMRF, Nagaraj SB. Novel drug-independent sedation level estimation based on machine learning of quantitative frontal electroencephalogram features in healthy volunteers. Br J Anaesth. 2019 Oct;123(4):479-487. doi: 10.1016/j.bja.2019.06.004. Epub 2019 Jul 18.

    PMID: 31326088DERIVED

  • Kuizenga MH, Colin PJ, Reyntjens KMEM, Touw DJ, Nalbat H, Knotnerus FH, Vereecke HEM, Struys MMRF. Test of neural inertia in humans during general anaesthesia. Br J Anaesth. 2018 Mar;120(3):525-536. doi: 10.1016/j.bja.2017.11.072. Epub 2017 Dec 1.

    PMID: 29452809DERIVED

Results Point of Contact

Title
Vikram Ramakanth
Organization
Masimo
clinicalresearchdept@masimo.com

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2014

First Posted

January 23, 2014

Study Start

December 16, 2013

Primary Completion

June 4, 2015

Study Completion

June 4, 2015

Last Updated

May 2, 2018

Results First Posted

May 2, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)