A Study of Human Multi-Sensory Integration

NCT03498391 | Suspended Phase 2 DMC FDA Drug

• 1 other identifier: 829800
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia Awareness

Outcome Measures

Primary Outcomes (1)

• Multi-sensory Evoked Responses Measured using Electroencephalography

  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.

  2-6 hours per subject

Secondary Outcomes (1)

• Single Modality Evoked Potentials

  2-6 hours per subject

Study Arms (2)

Propofol

EXPERIMENTAL

Propofol sedation titrated to clinical effect as measured by Richmond Agitation-Sedation Scale.

Drug: Propofol

Ketamine

EXPERIMENTAL

Ketamine sedation titrated to clinical effect as measured by Richmond Agitation-Sedation Scale.

Drug: Ketamine Injectable Product

Interventions

Propofol DRUG

Titration of propofol to minimal and moderate sedation as measured by Richmond Agitation-Sedation Scale with behavioral task performance over several hours.

Also known as: Diprivan

Propofol

Ketamine Injectable Product DRUG

Titration of ketamine to minimal and moderate sedation as measured by Richmond Agitation-Sedation Scale with behavioral task performance over several hours.

Also known as: Ketalar

Ketamine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania, Perelman School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Intraoperative Awareness

Interventions

Propofol; Ketamine

Condition Hierarchy (Ancestors)

Intraoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic

Study Officials

• Max Kelz, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: April 13, 2018
• Study Start: July 30, 2018
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)