Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03140982
Acronym
Top&Bottom
Enrollment
16
Registered
2017-05-04
Start date
2016-06-01
Completion date
2016-12-15
Last updated
2017-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia; Functional

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

DIAGNOSTIC_TESTFOUR coma scale and frontal espectrograpy evaluation

systematic evaluation using the validated FOUR coma scale during propofol administration

Sponsors

Universidad del Desarrollo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

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

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

MeasureTime frameDescription
loss of consciousness a cortical or brainsteam phenomenon1 yearwith 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

MeasureTime frameDescription
evaluation of the alfa band behavior after fast and slow inductions1 yearthe investigators analyze the time delay in stabilizing the frontal alfa band after fast and slow anesthesia inductions

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026