Is Anesthetic Loss of Consciousness a Top Down or Bottom up Phenomenon. What Does the Neurologic Examination Say?.
NCT ID: NCT03140982
Last Updated: 2017-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2016-06-01
2016-12-15
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
TRIPLE
Study Groups
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GR fast induction
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.
FOUR coma scale and frontal espectrograpy evaluation
systematic evaluation using the validated FOUR coma scale during propofol administration
GL slow induction
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.
FOUR coma scale and frontal espectrograpy evaluation
systematic evaluation using the validated FOUR coma scale during propofol administration
Interventions
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FOUR coma scale and frontal espectrograpy evaluation
systematic evaluation using the validated FOUR coma scale during propofol administration
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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Universidad del Desarrollo
OTHER
Responsible Party
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Pablo O. Sepulveda
MD. Professor in Anesthesia
Principal Investigators
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Pablo Lavados, MD
Role: STUDY_CHAIR
Clinica Alemana Comité Cientifico
Locations
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Clinica Alemana de Santiago
Santiago, Santiago Metropolitan, Chile
Countries
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References
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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.
Mashour GA. Top-down mechanisms of anesthetic-induced unconsciousness. Front Syst Neurosci. 2014 Jun 23;8:115. doi: 10.3389/fnsys.2014.00115. eCollection 2014.
Wijdicks 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.
Other Identifiers
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Centro Bioetica 2016-05
Identifier Type: -
Identifier Source: org_study_id