Anesthesia; Functional
Conditions
Keywords
propofol, pharmacology, anesthesic induction, drug titration
Brief 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.
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.
Interventions
systematic evaluation using the validated FOUR coma scale during propofol administration
Sponsors
Study design
Masking description
after patient constent, and previos the patient arriving the OR, the care provider (designed anesthestist) using a coin decide the arm (GR or GL). The neurologist and investigator was blind to the arm.
Intervention model description
comparison of the neurologic behavior between two group, a fast and a slow anesthesia induction
Eligibility
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| loss of consciousness a cortical or brainsteam phenomenon | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| evaluation of the alfa band behavior after fast and slow inductions | 1 year | the investigators analyze the time delay in stabilizing the frontal alfa band after fast and slow anesthesia inductions |
Countries
Chile