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A Study of Human Multi-Sensory Integration (MSI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03498391
Recruitment Status : Suspended (Due to the impact of COVID-19)
First Posted : April 13, 2018
Last Update Posted : March 27, 2020
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE March 12, 2018
First Posted Date  ICMJE April 13, 2018
Last Update Posted Date March 27, 2020
Actual Study Start Date  ICMJE July 30, 2018
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2018)
Multi-sensory Evoked Responses Measured using Electroencephalography [ Time Frame: 2-6 hours per subject ]
The primary study endpoint is multi-sensory evoked responses measured using EEG in units of millivolts squared per hertz at Richmond Agitation and Sedation Scale scores of 0, -1, -2, -3 and -4. Multisensory evoked responses will be compared to those evoked by each uni-sensory modality (auditory and visual) individually. Evoked responses will be assessed in the frequency domain using spectral analysis techniques which quantify power of each neuronal oscillation (e.g. alpha, delta, theta and gamma) in terms of mV^2/Hz. Analysis will be performed separately during the period before drug administration and at different levels of sedation quantified with RASS scores. The investigators will test the hypothesis that with increasing doses of intravenous anesthetics, audiovisual (multisensory) responses will approximate algebraic sum of neuronal responses elicited by visual and auditory stimuli presented separately.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2018)
Single Modality Evoked Potentials [ Time Frame: 2-6 hours per subject ]
The secondary endpoint is to use EEG recordings to demonstrate changes in the characteristics of evoked potentials under anesthesia using single sensory modality (visual, auditory) and across sensory modalities. Conventional evoked potentials will be computed as average waveforms aligned with respect to stimulus onset on a channel-by-channel basis.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Human Multi-Sensory Integration
Official Title  ICMJE A Study of Human Multi-Sensory Integration: A Neurophysiologic Correlate of Conscious Perception
Brief Summary

The primary aim of this study is to determine whether spatiotemporal characteristics of multisensory evoked potentials can be used as a marker of consciousness (awareness) under anesthesia.

The secondary aim is to characterize changes in the characteristics of evoked potentials under anesthesia in both single sensory modality (visual, auditory) and across sensory modalities.

Detailed Description

This is a prospective, dual parallel arm human subject study aimed at determining the relationship between level of sedation (consciousness) and features of multi and uni-sensory evoked potentials with the ultimate goal of developing novel means of detecting consciousness under anesthesia with potential for application to other clinical settings such as brain injury. For this purpose, the investigators have chosen two anesthetics with fundamentally distinct mechanisms of action: propofol and ketamine.

The study will involve healthy compensated volunteers. On the day of the study, an EEG cap will be applied to the participant for monitoring brain activity and an intravenous line will be placed for drug administration. Blood pressure, ECG, pulse oxymetry, and end-tidal carbon dioxide (from nasal cannula) will be monitored. Supplemental oxygen will be administered using a nasal cannula. Subjects will then perform the behavioral tasks in the awake state for approximately 1 hour.

After this phase is complete, participants will receive either propofol or ketamine (chosen permuted block randomization) using a clinician bolus/infusion strategy titrated to Richmond Agitation-Sedation Scale score of -1 (see above). Once the desired sedation level is achieved, subjects will once again complete the behavioral tasks. After the completion of this phase (approximately 1 hour) the anesthetic dose will be increased to attain Richmond Agitation-Sedation Scale -3 to -4. At this level of sedation subjects will not be able to do the behavioral task and only the evoked potentials will be recorded. Upon completion of this phase (approximately 1 hour), sedation level will be decreased to return the subject to a Richmond Agitation-Sedation Scale of -1 and once again the tasks will be repeated.

Finally, the anesthetic infusion will be stopped. Once the Richmond Agitation-Sedation Scale score of 0 is attained, participants will once again perform the behavioral task (approximately 1 hour). This will conclude the experimental phase of the trial. Subjects will be monitored until clinically established discharge criteria are met. This includes adequate respiration, blood pressure, oxygen saturation and activity level. No formal follow-up is required; however, subjects will be called 24 hours after study completion.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Anesthesia Awareness
Intervention  ICMJE
  • Drug: Propofol
    Titration of propofol to minimal and moderate sedation as measured by Richmond Agitation-Sedation Scale with behavioral task performance over several hours.
    Other Name: Diprivan
  • Drug: Ketamine Injectable Product
    Titration of ketamine to minimal and moderate sedation as measured by Richmond Agitation-Sedation Scale with behavioral task performance over several hours.
    Other Name: Ketalar
Study Arms  ICMJE
  • Experimental: Propofol
    Propofol sedation titrated to clinical effect as measured by Richmond Agitation-Sedation Scale.
    Intervention: Drug: Propofol
  • Experimental: Ketamine
    Ketamine sedation titrated to clinical effect as measured by Richmond Agitation-Sedation Scale.
    Intervention: Drug: Ketamine Injectable Product
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: April 6, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy volunteers ages 18-65 years old
  • American Society of Anesthesiologists (ASA) Physical Status I or II (i.e. healthy)
  • Body Mass Index <30 kg/m2
  • Easily visible uvula

Exclusion Criteria:

  • Contraindications to administration of either propofol or ketamine
  • Allergy to either one of the medications or preservative in which it is diluted.
  • History (or current) seizure disorder
  • Contraindications to anesthesia
  • Significant cardiovascular disease (e.g. h/o hypertension, arrhythmias, myocardial infarction, congestive heart failure, congenital heart defects, coronary artery disease)
  • Increased risk factors for difficult intubation and/or ventilation
  • Obesity (BMI>=30 kg/m2)
  • Mallampati class > 2.
  • History of or current obstructive sleep apnea.
  • Increased risk of aspiration
  • Any per oral intake within 8 hours of anesthetic exposure
  • Conditions that delay gastric emptying (e.g. obesity, hiatal hernia, gastro esophageal reflux disease, pregnancy, etc.)
  • Pulmonary disease (e.g. chronic obstructive pulmonary disorder, asthma requiring rescue inhaler within last month, emphysema, pulmonary hypertension, pulmonary fibrosis etc).

    • Neurological disease. Patients with history of strokes, seizures, brain surgery, brain tumor, increased intracranial pressure.
    • Psychiatric disease. History of or presents of psychosis, schizophrenia, schizo-affective disorder.
    • Specific Medication Current Use. History of or current intake of antipsychotics or sedatives.
    • Drug abuse. History of or current use of illegal drugs such as stimulants or depressants.
    • Pregnancy or breastfeeding
    • Inability to provide informed consent
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03498391
Other Study ID Numbers  ICMJE 829800
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Max Kelz, MD, PhD University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP