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AnesthesiaPhase 4NCT02624401

The Neural Mechanisms of Anesthesia and Human Consciousness (Part 6)

A Phase 4 study testing Dexmedetomidine, Propofol and S-ketamine in people with Anesthesia and Unconsciousness, run by University of Turku at 1 site in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Positron Emission Tomography (PET), Magnetic Resonance Imaging (MRI) and electroencephalography (EEG) studies will be carried out to reveal the neural correlates of consciousness. Consciousness of the subjects will be manipulated with anesthetic agents dexmedetomidine, propofol, S-ketamine and sevoflurane. Read more about this study

Who is it for?
Ages 18 to 30 years, men onlyHealthy volunteers can take part
Conditions the study is for
Anesthesia, Unconsciousness
What is being tested?
Dexmedetomidine, Propofol and S-ketamine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
160 participants
Where
1 siteFinland
Study dates
Jan 2016to 13 Mar 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male
  • Age 18-30 years
  • Good general health i.e. American Society of Anesthesiologists (ASA) physical status I
  • Fluent in Finnish language
  • Right handedness
  • Written informed consent
  • Good sleep quality

Who cannot join

  • Chronic medication
  • History of alcohol and/or drug abuse
  • Strong susceptibility for allergic reactions
  • Serious nausea in connection with previous anesthesia
  • Strong susceptibility for nausea
  • Any use of drugs or alcohol during the 48 hours preceding anesthesia
Show all 18Show fewer
  • Use of caffeine products 10-12 hours prior the study
  • Smoking
  • Clinically significant previous cardiac arrhythmia / cardiac conduction impairment
  • Clinically significant abnormality in prestudy laboratory tests
  • Positive result in the drug screening test
  • Blood donation within 90 days prior to the study
  • Participation in any medical study with an experimental drug or device during the preceding 60 days
  • The study subject has undergone a prior PET or SPECT study
  • Any contraindication to magnetic resonance imaging (MRI)
  • Hearing impairment
  • Detected unsuitability based on MRI scanning results if available before the PET scanning
  • Sleep disorder or severe sleep problem

Trial locations and contacts

1 site in 1 country.

Finland1 site

  • Turku PET Centre

    Turku, FI-20521

Other trials in Finland

About this study

Positron Emission Tomography (PET), Magnetic Resonance Imaging (MRI) and electroencephalography (EEG) studies will be carried out to reveal the neural correlates of consciousness. Consciousness of the subjects will be manipulated with anesthetic agents dexmedetomidine, propofol, S-ketamine and sevoflurane. One-hundred-and-sixty (160) healthy male subjects will be recruited to receive EC50 concentration of the anesthetic (40 dexmedetomidine, 40 propofol, 20 S-ketamine, 40 sevoflurane) or placebo (20) while being imaged for cerebral metabolic rate of glucose (CMRglu). Also genetic, immunological and metabolomics samples will be taken and analysed to find possible genetic factors explaining the variability in drug response and to find chemical fingerprints of acute drug effect.

Read the detailed description

The explanation of consciousness poses one of the greatest challenges to science and philosophy in the 21st century. It remains unclear what consciousness is and how it emerges from brain activity. Positron Emission Tomography (PET), Magnetic Resonance Imaging (MRI) and electroencephalography (EEG) studies will be carried out to reveal the neural correlates of consciousness. Consciousness of the subjects will be manipulated with anesthetic agents dexmedetomidine acting through α2-agonism, with propofol and sevoflurane both mainly acting through the enhancement of gamma-aminobutyric acid (GABA) system, and with S-ketamine acting through N-methyl-D-aspartate (NMDA) receptor antagonism. One-hundred-and-sixty (160) healthy male subjects will be recruited to receive EC50 concentration of either dexmedetomidine, propofol, S-ketamine or sevoflurane, or placebo while being imaged for cerebral metabolic rate of glucose (CMRglu). 40 subjects will receive dexmedetomidine, 40 subjects propofol, 20 subjects S-ketamine, 40 subjects sevoflurane and 20 subjects will receive placebo. Also genetic, immunological and metabolomics samples will be taken and analysed to find possible genetic factors explaining the variability in drug response and to find possible immunological and chemical fingerprints of acute drug effect.

Being tested
Dexmedetomidine, Propofol, S-ketamine, Sevoflurane, Placebo
Medical subject headings
Unconsciousness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexmedetomidineDrug

    Also called Dexdor

    Intravenous infusion

  • PropofolDrug

    Also called Propofol-Lipuro

    Intravenous infusion

  • S-ketamineDrug

    Also called Ketanest-S

    Intravenous infusion

  • SevofluraneDrug

    Also called Sevorane

    Inhalation

  • PlaceboDrug

    Intravenous infusion of saline (Ringer's Acetate)

Study groups in NCT02624401
Study groupRoleWhat they receive
DexmedetomidineExperimentalIntravenous dexmedetomidine using target controlled infusion.
Receives: Drug: Dexmedetomidine
PropofolExperimentalIntravenous propofol using target controlled infusion.
Receives: Drug: Propofol
S-ketamineExperimentalIntravenous S-ketamine using target controlled infusion.
Receives: Drug: S-ketamine
SevofluraneExperimentalInhalational sevoflurane using target controlled inhalation.
Receives: Drug: Sevoflurane
PlaceboPlacebo comparatorIntravenous saline.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Regional cerebral metabolism of glucose

    Comparison of responsive and unresponsive subjects

    Measured: 40 min

Secondary outcomes (6)

  1. EEG

    64-channel EEG will be recorded and analyzed using time domain, spectral domain, functional connectivity, directed/effective connectivity and graph theoretical analysis methods.

    Measured: 1 hour

  2. Immunological effects

    Blood samples will be draw at baseline (without drug), at the end of study drug administration and after PET scanning for the measurement of approximately 50 cytokines, chemokines and growth factors.

    Measured: 2 hours

  3. Metabolomic effects

    Blood samples will be drawn at baseline (without drug), at the end of drug administration and after PET scanning for the measurement of more than 200 serum measures, including lipoprotein subclass distribution and lipoprotein particle concentration, low molecular weight metabolites, such as amino acids, 3-hydroxybutyrate and creatinine, and detailed molecular information on serum lipids, including free and esterified cholesterol, sphingomyelin and fatty acid saturation.

    Measured: 2 hours

  4. Gene expression

    Blood samples will be collected at baseline (without drug), at the end of drug administration and after PET scanning for the measurement of RNA expression using whole genome microarray-based, massively parallel sequencing or quantitative reverse-transcription polymerase chain reaction based methods.

    Measured: 2 hours

  5. Psychological well-being

    Psychological well-being and ill-being will be measured with a battery of scientifically validated scales just before initiating the study session and at the end of the study session.

    Measured: 2 hours

  6. Dream report

    After terminating PET imaging, a structured interview is immediately conducted to verify a recollection or absence of recollection of subjective experiences during possible loss of responsiveness.

    Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2015 (estimated)
  2. Study startJan 2016
  3. Primary completion13 Mar 2017
  4. Study completion13 Mar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02624401
Sponsor's protocol ID
LOC-2016
Status last verified
Mar 2017
First submitted
25 Nov 2015
Last updated
27 Mar 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Langsjo JW, Alkire MT, Kaskinoro K, Hayama H, Maksimow A, Kaisti KK, Aalto S, Aantaa R, Jaaskelainen SK, Revonsuo A, Scheinin H. Returning from oblivion: imaging the neural core of consciousness. J Neurosci. 2012 Apr 4;32(14):4935-43. doi: 10.1523/JNEUROSCI.4962-11.2012.

    PubMed 22492049

  • Langsjo JW, Revonsuo A, Scheinin H. Harnessing anesthesia and brain imaging for the study of human consciousness. Curr Pharm Des. 2014;20(26):4211-24.

    PubMed 24025060

  • Nummela A, Laaksonen L, Scheinin A, Kaisti K, Vahlberg T, Neuvonen M, Valli K, Revonsuo A, Perola M, Niemi M, Scheinin H, Laitio T. Circulating oxylipin and bile acid profiles of dexmedetomidine, propofol, sevoflurane, and S-ketamine: a randomised controlled trial using tandem mass spectrometry. BJA Open. 2022 Dec 12;4:100114. doi: 10.1016/j.bjao.2022.100114. eCollection 2022 Dec.

    PubMed 37588789

  • Nummela AJ, Laaksonen LT, Laitio TT, Kallionpaa RE, Langsjo JW, Scheinin JM, Vahlberg TJ, Koskela HT, Aittomaki V, Valli KJ, Revonsuo A, Niemi M, Perola M, Scheinin H. Effects of dexmedetomidine, propofol, sevoflurane and S-ketamine on the human metabolome: A randomised trial using nuclear magnetic resonance spectroscopy. Eur J Anaesthesiol. 2022 Jun 1;39(6):521-532. doi: 10.1097/EJA.0000000000001591. Epub 2021 Sep 22.

    PubMed 34534172

  • Laaksonen L, Kallioinen M, Langsjo J, Laitio T, Scheinin A, Scheinin J, Kaisti K, Maksimow A, Kallionpaa RE, Rajala V, Johansson J, Kantonen O, Nyman M, Siren S, Valli K, Revonsuo A, Solin O, Vahlberg T, Alkire M, Scheinin H. Comparative effects of dexmedetomidine, propofol, sevoflurane, and S-ketamine on regional cerebral glucose metabolism in humans: a positron emission tomography study. Br J Anaesth. 2018 Jul;121(1):281-290. doi: 10.1016/j.bja.2018.04.008. Epub 2018 May 8.

    PubMed 29935583

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexmedetomidine, Propofol and S-ketamine in people with Anesthesia and Unconsciousness, run by University of Turku at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Regional cerebral metabolism of glucose (time frame: 40 min). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02624401, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2017.

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