NCT03498391

A Study of Human Multi-Sensory Integration

A Study of Human Multi-Sensory Integration: A Neurophysiologic Correlate of Conscious Perception

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Anesthesia Awareness

Interventions

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

Timeline

• Start date: 2018-07-30
• Primary completion: 2023-05-01
• Completion: 2023-05-01
• First posted: 2018-04-13
• Last updated: 2023-02-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study