Anesthesia; FunctionalTop&BottomNCT03140982
Is Anesthetic Loss of Consciousness a Top Down or Bottom up Phenomenon. What Does the Neurologic Examination Say?.
A study testing FOUR coma scale and frontal espectrograpy evaluation in people with Anesthesia; Functional, run by Universidad del Desarrollo at 1 site in Chile.
Trial summary
Using very slow or fast propofol intravenous injection, monitored using standard American Society of Anesthesiology (ASA) standard and SEDLine EEG (Med Tech), the patient was evaluate by a neurologist every 30 sec using the FOUR coma scale. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia; Functional
- What is being tested?
- FOUR coma scale and frontal espectrograpy evaluation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChile
- Study dates
- 1 Jun 2016to 15 Dec 2016
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: ASA 1-2 patients programmed for elective surgery, normal neurologic examination -
Exclusion Criteria: neurologic illness, receiving drugs that affect Central Nervous System during the last 48 hours
-
Trial locations and contacts
1 site in 1 country.
Chile1 site
Clinica Alemana de Santiago
Santiago, Santiago Metropolitan, 7600000
About this study
Official title: Is Anesthetic Loss of Consciousness a Cortical or Brainstem Phenomenon? What Does the Neurological Examination Say?
Using very slow or fast propofol intravenous injection, monitored using standard American Society of Anesthesiology (ASA) standard and SEDLine EEG (Med Tech), the patient was evaluate by a neurologist every 30 sec using the FOUR coma scale.
Read the detailed description
Clinical experimental randomized study, approved by the Ethic Committee, with informed consent, included ASA I- II adults, without neurological illness and normal physical exam.
The patient randomized in two groups, rapid induction (GR) with propofol in target controlled infusion (TCI) effect site mode using the phamacokinetic (PK) model from Marsh ke0 1,21 min-1 using a calculated target of 5.4 ug/ml (loss of counsciousness EC95) and slow induction (GL) 10 mg/kg/h with calculated effect site concentrations (CeCALC) same PK model.
The same neurologist, blind to the correspondent group, evaluated all the patients every 30 sec using the coma FOUR scale until loss of counsciousness (LOC), defined as a FOUR (E0 no eyes opening response and /or M0 no motor response). At LOC the existance of brainstem reflex was evaluated (B no pupil and corneal reflex), respiratory pattern (R apnoea), CeCALC and patient state index (PSI) SEDline™ was recorded during all the examination.
After LOC in both groups we maintain in GR the initial target (5.3 ug/ml) and the LOC CeCALC during 10 min without intervention, except respiratory support if it was required.
Frontal EEG 4 channel and spectrogram from SEDline monitor was extracted for each case and posterior analysis.
Fisher exact test was used to describe primary outcome and difference between B and R for each group. The difference in time to reach LOC LOC, Ce and PSI was analysed with T- Student.
- Conditions
- Anesthesia; Functional
- Being tested
- FOUR coma scale and frontal espectrograpy evaluation
- Keywords
- propofol, pharmacology, anesthesic induction, drug titration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOUR coma scale and frontal espectrograpy evaluationDiagnostic test
Also called 4 channel EEG record with SEDline monitor, Non Invasive Blood presure, Saturation 02, Electrocardiogram, propofol infusion in Target controlled infusion using Primea Orchestra infusion pump Fressenius Kabi
systematic evaluation using the validated FOUR coma scale during propofol administration
| Study group | Role | What they receive |
|---|---|---|
| GR fast induction | Active comparator | propofol TCI effect site mode infusion using the PK Marsh model ke0 1,21 min-1 target 5.4 ug/ml (LOC EC95) util loss of consciousness (LOC) After LOC we maintain initial target during 10 min without intervention, except respiratory support if required. Receives: Diagnostic Test: FOUR coma scale and frontal espectrograpy evaluation |
| GL slow induction | Active comparator | propofol infused at 10 mg/kg/h with CeCALC PK Marsh model ke0 1,21 min-1 same PK model After LOC we maintain the CeCALC observed al LOC during 10 min without intervention, except respiratory support if it was required. Receives: Diagnostic Test: FOUR coma scale and frontal espectrograpy evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
loss of consciousness a cortical or brainsteam phenomenon
with fast and slow induction we use the FOUR coma scale ( Ann Neurol. 2005;58(4): 585-93) to identify lost of brain stem activities.
Measured: 1 year
Secondary outcomes (1)
evaluation of the alfa band behavior after fast and slow inductions
the investigators analyze the time delay in stabilizing the frontal alfa band after fast and slow anesthesia inductions
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start1 Jun 2016
- Primary completion15 Dec 2016
- Study completion15 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anesthesia; FunctionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- comparison of the neurologic behavior between two group, a fast and a slow anesthesia induction
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad del Desarrollo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pablo O. Sepulveda, Universidad del Desarrollo
- Investigators
- Pablo Lavados, MD, Study chair, Clinica Alemana Comité Cientifico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140982
- Sponsor's protocol ID
- Centro Bioetica 2016-05
- Acronym
- Top&Bottom
- Status last verified
- May 2017
- First submitted
- 10 Apr 2017
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brown EN, Lydic R, Schiff ND. General anesthesia, sleep, and coma. N Engl J Med. 2010 Dec 30;363(27):2638-50. doi: 10.1056/NEJMra0808281. No abstract available.
PubMed 21190458Mashour GA. Top-down mechanisms of anesthetic-induced unconsciousness. Front Syst Neurosci. 2014 Jun 23;8:115. doi: 10.3389/fnsys.2014.00115. eCollection 2014.
PubMed 25002838Wijdicks EF, Bamlet WR, Maramattom BV, Manno EM, McClelland RL. Validation of a new coma scale: The FOUR score. Ann Neurol. 2005 Oct;58(4):585-93. doi: 10.1002/ana.20611.
PubMed 16178024
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Anesthetic Loss of Consciousness a Cortical or Brainstem Phenomenon? What Does the Neurological Examination Say?
- ClinicalTrials.gov ID
- NCT03140982
- Acronym / sponsor ID
- Top&Bottom / Centro Bioetica 2016-05
- Conditions
- Anesthesia; Functional
- Keywords
- propofol, pharmacology, anesthesic induction, drug titration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Universidad del DesarrolloUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 15 Dec 2016 (actual)
- Study completion
- 15 Dec 2016 (actual)
- First posted
- 4 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Using very slow or fast propofol intravenous injection, monitored using standard American Society of Anesthesiology (ASA) standard and SEDLine EEG (Med Tech), the patient was evaluate by a neurologist every 30 sec using the FOUR coma scale.
Detailed description
Clinical experimental randomized study, approved by the Ethic Committee, with informed consent, included ASA I- II adults, without neurological illness and normal physical exam.
The patient randomized in two groups, rapid induction (GR) with propofol in target controlled infusion (TCI) effect site mode using the phamacokinetic (PK) model from Marsh ke0 1,21 min-1 using a calculated target of 5.4 ug/ml (loss of counsciousness EC95) and slow induction (GL) 10 mg/kg/h with calculated effect site concentrations (CeCALC) same PK model.
The same neurologist, blind to the correspondent group, evaluated all the patients every 30 sec using the coma FOUR scale until loss of counsciousness (LOC), defined as a FOUR (E0 no eyes opening response and /or M0 no motor response). At LOC the existance of brainstem reflex was evaluated (B no pupil and corneal reflex), respiratory pattern (R apnoea), CeCALC and patient state index (PSI) SEDline™ was recorded during all the examination.
After LOC in both groups we maintain in GR the initial target (5.3 ug/ml) and the LOC CeCALC during 10 min without intervention, except respiratory support if it was required.
Frontal EEG 4 channel and spectrogram from SEDline monitor was extracted for each case and posterior analysis.
Fisher exact test was used to describe primary outcome and difference between B and R for each group. The difference in time to reach LOC LOC, Ce and PSI was analysed with T- Student.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- comparison of the neurologic behavior between two group, a fast and a slow anesthesia induction
| Arm | Type | Receives |
|---|---|---|
| GR fast induction | Active comparator | Diagnostic Test: FOUR coma scale and frontal espectrograpy evaluationpropofol TCI effect site mode infusion using the PK Marsh model ke0 1,21 min-1 target 5.4 ug/ml (LOC EC95) util loss of consciousness (LOC) After LOC we maintain initial target during 10 min without intervention, except respiratory support if required. |
| GL slow induction | Active comparator | Diagnostic Test: FOUR coma scale and frontal espectrograpy evaluationpropofol infused at 10 mg/kg/h with CeCALC PK Marsh model ke0 1,21 min-1 same PK model After LOC we maintain the CeCALC observed al LOC during 10 min without intervention, except respiratory support if it was required. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FOUR coma scale and frontal espectrograpy evaluationAlso: 4 channel EEG record with SEDline monitor, Non Invasive Blood presure, Saturation 02, Electrocardiogram, propofol infusion in Target controlled infusion using Primea Orchestra infusion pump Fressenius Kabisystematic evaluation using the validated FOUR coma scale during propofol administration | Diagnostic test | GL slow induction, GR fast induction |
Primary outcome
loss of consciousness a cortical or brainsteam phenomenon
Time frame: 1 year
with fast and slow induction we use the FOUR coma scale ( Ann Neurol. 2005;58(4): 585-93) to identify lost of brain stem activities.
1 secondary outcome
evaluation of the alfa band behavior after fast and slow inductions
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Background: PubMed 21190458Brown EN, Lydic R, Schiff ND. General anesthesia, sleep, and coma. N Engl J Med. 2010 Dec 30;363(27):2638-50. doi: 10.1056/NEJMra0808281. No abstract available.
- Background: PubMed 25002838Mashour GA. Top-down mechanisms of anesthetic-induced unconsciousness. Front Syst Neurosci. 2014 Jun 23;8:115. doi: 10.3389/fnsys.2014.00115. eCollection 2014.
- Background: PubMed 16178024Wijdicks EF, Bamlet WR, Maramattom BV, Manno EM, McClelland RL. Validation of a new coma scale: The FOUR score. Ann Neurol. 2005 Oct;58(4):585-93. doi: 10.1002/ana.20611.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pablo Lavados, MD study chair
Clinica Alemana Comité Cientifico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FOUR coma scale and frontal espectrograpy evaluation in people with Anesthesia; Functional, run by Universidad del Desarrollo at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 31 May 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 Chile. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
loss of consciousness a cortical or brainsteam phenomenon (time frame: 1 year). 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 NCT03140982, which also lists 3 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 31 May 2017.