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

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ClinicalTrials.gov Identifier: NCT03140982
Recruitment Status : Completed
First Posted : May 4, 2017
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
Pablo O. Sepulveda, Universidad del Desarrollo

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.

Condition or disease Intervention/treatment
Anesthesia; Functional Diagnostic Test: FOUR coma scale and frontal espectrograpy evaluation

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: comparison of the neurologic behavior between two group, a fast and a slow anesthesia induction
Masking: Triple (Participant, 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.
Primary Purpose: Diagnostic
Official Title: Is Anesthetic Loss of Consciousness a Cortical or Brainstem Phenomenon? What Does the Neurological Examination Say?
Actual Study Start Date : June 1, 2016
Primary Completion Date : December 15, 2016
Study Completion Date : December 15, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia Coma
Drug Information available for: Propofol
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 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.
Diagnostic Test: FOUR coma scale and frontal espectrograpy evaluation
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
Active Comparator: 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.
Diagnostic Test: FOUR coma scale and frontal espectrograpy evaluation
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 Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03140982


Locations
Chile
Clinica Alemana de Santiago
Santiago, Region Metropolitana, Chile, 7600000
Sponsors and Collaborators
Universidad del Desarrollo
Investigators
Study Chair: Pablo Lavados, MD Clinica Alemana Comité Cientifico

Publications:
Responsible Party: Pablo O. Sepulveda, MD. Professor in Anesthesia, Universidad del Desarrollo
ClinicalTrials.gov Identifier: NCT03140982     History of Changes
Other Study ID Numbers: Centro Bioetica 2016-05
First Posted: May 4, 2017    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pablo O. Sepulveda, Universidad del Desarrollo:
propofol
pharmacology
anesthesic induction
drug titration

Additional relevant MeSH terms:
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Propofol
Anesthetics
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General