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Completed

NCT Number: NCT03140982

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica Alemana de Santiago

Santiago, Santiago Metropolitan, 7600000, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

FOUR coma scale and frontal espectrograpy evaluation

Diagnostic Test

systematic evaluation using the validated FOUR coma scale during propofol administration

Other names: 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

Primary outcomes

  1. 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.

Secondary outcomes

  1. evaluation of the alfa band behavior after fast and slow inductions

    Time frame: 1 year

    the investigators analyze the time delay in stabilizing the frontal alfa band after fast and slow anesthesia inductions

Sponsors and collaborators

Lead sponsor

Universidad del Desarrollo

Other

Registry information

Official study title

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

Acronym: Top&Bottom

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 4, 2017
Registry last updated
May 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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