Is Anesthetic Loss of Consciousness a Top Down or Bottom up Phenomenon. What Does the Neurologic Examination Say?.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Is Anesthetic Loss of Consciousness a Cortical or Brainstem Phenomenon? What Does the Neurological Examination Say?

Conditions
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Anesthesia; Functional

Intervention / Treatment
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* Diagnostic Test: FOUR coma scale and frontal espectrograpy evaluation


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: comparison of the neurologic behavior between two group, a fast and a slow anesthesia induction
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GR fast induction<br>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. | Diagnostic Test: FOUR coma scale and frontal espectrograpy evaluation<br>* systematic evaluation using the validated FOUR coma scale during propofol administration<br>* Other names: propofol infusion in Target controlled infusion using Primea Orchestra infusion pump Fressenius Kabi;|
| Active Comparator: GL slow induction<br>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. | Diagnostic Test: FOUR coma scale and frontal espectrograpy evaluation<br>* systematic evaluation using the validated FOUR coma scale during propofol administration<br>* Other names: propofol infusion in Target controlled infusion using Primea Orchestra infusion pump Fressenius Kabi;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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propofol, pharmacology, anesthesic induction, drug titration