A Study of Human Multi-Sensory Integration

Paused · Phase 2

Conditions studied: Anesthesia Awareness

In brief

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.

Key facts

Study ID

NCT03498391

Run by

University of Pennsylvania

People needed

40

Starts

2018-07-30

Expected to finish

2023-05-01

Last updated by the study team

2023-02-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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.
• 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

Where it is running

• University of Pennsylvania, Perelman School of Medicine — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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