search
Back to results

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

Primary Purpose

Anesthesia; Functional

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
FOUR coma scale and frontal espectrograpy evaluation
Sponsored by
Universidad del Desarrollo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Anesthesia; Functional focused on measuring propofol, pharmacology, anesthesic induction, drug titration

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

-

Sites / Locations

  • Clinica Alemana de Santiago

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

GR fast induction

GL slow induction

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 10, 2017
Last Updated
May 26, 2017
Sponsor
Universidad del Desarrollo
search

1. Study Identification

Unique Protocol Identification Number
NCT03140982
Brief Title
Is Anesthetic Loss of Consciousness a Top Down or Bottom up Phenomenon. What Does the Neurologic Examination Say?.
Acronym
Top&Bottom
Official Title
Is Anesthetic Loss of Consciousness a Cortical or Brainstem Phenomenon? What Does the Neurological Examination Say?
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
December 15, 2016 (Actual)
Study Completion Date
December 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad del Desarrollo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia; Functional
Keywords
propofol, pharmacology, anesthesic induction, drug titration

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
comparison of the neurologic behavior between two group, a fast and a slow anesthesia induction
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GR fast induction
Arm Type
Active Comparator
Arm Description
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.
Arm Title
GL slow induction
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
FOUR coma scale and frontal espectrograpy evaluation
Other Intervention Name(s)
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
Intervention Description
systematic evaluation using the validated FOUR coma scale during propofol administration
Primary Outcome Measure Information:
Title
loss of consciousness a cortical or brainsteam phenomenon
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
evaluation of the alfa band behavior after fast and slow inductions
Description
the investigators analyze the time delay in stabilizing the frontal alfa band after fast and slow anesthesia inductions
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pablo Lavados, MD
Organizational Affiliation
Clinica Alemana Comité Cientifico
Official's Role
Study Chair
Facility Information:
Facility Name
Clinica Alemana de Santiago
City
Santiago
State/Province
Region Metropolitana
ZIP/Postal Code
7600000
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21190458
Citation
Brown EN, Lydic R, Schiff ND. General anesthesia, sleep, and coma. N Engl J Med. 2010 Dec 30;363(27):2638-50. doi: 10.1056/NEJMra0808281. No abstract available.
Results Reference
background
PubMed Identifier
25002838
Citation
Mashour GA. Top-down mechanisms of anesthetic-induced unconsciousness. Front Syst Neurosci. 2014 Jun 23;8:115. doi: 10.3389/fnsys.2014.00115. eCollection 2014.
Results Reference
background
PubMed Identifier
16178024
Citation
Wijdicks EF, Bamlet WR, Maramattom BV, Manno EM, McClelland RL. Validation of a new coma scale: The FOUR score. Ann Neurol. 2005 Oct;58(4):585-93. doi: 10.1002/ana.20611.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs