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

NCT03140982 | Completed

• 1 other identifier: Centro Bioetica 2016-05
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Functional

Keywords

propofol; pharmacology; anesthesic induction; drug titration

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (1)

• evaluation of the alfa band behavior after fast and slow inductions

  1 year

Study Arms (2)

GR fast induction

ACTIVE COMPARATOR

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

GL slow induction

ACTIVE COMPARATOR

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

Interventions

FOUR coma scale and frontal espectrograpy evaluation DIAGNOSTIC_TEST

systematic evaluation using the validated FOUR coma scale during propofol administration

Also known as: 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

GL slow induction; GR fast induction

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Universidad del Desarrollo: lead

Study Sites (1)

Clinica Alemana de Santiago

Santiago, Santiago Metropolitan, 7600000, Chile

Location

Related Publications (3)

• 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.

  PMID: 21190458 BACKGROUND

• 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.

  PMID: 25002838 BACKGROUND

• 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.

  PMID: 16178024 BACKGROUND

MeSH Terms

Interventions

Electrocardiography

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Pablo Lavados, MD

  Clinica Alemana Comité Cientifico

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. Professor in Anesthesia

Model Details: comparison of the neurologic behavior between two group, a fast and a slow anesthesia induction

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: May 4, 2017
• Study Start: June 1, 2016
• Primary Completion: December 15, 2016
• Study Completion: December 15, 2016
• Last Updated: May 31, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)