Neuroimaging of Anesthetic Modulation of Human Consciousness

NCT03361605 | Completed Phase 4 Results FDA Drug

• 1 other identifier: HUM00103361
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study's purpose is to see if mental functions take place during different levels of anesthesia, using a commonly used drug (Propofol). fMRI (functional Magnetic Resonance Imaging, or "brain imaging") shows areas in the brain involved in thinking at different depths of anesthesia.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Blood Oxygen Level Dependent (BOLD) Response to Sensory Stimuli During Sedation

  Change = BOLD Response During Sedation - BOLD Response During Baseline

  Baseline to 90 minutes

Secondary Outcomes (1)

• Change From Baseline in Squeeze Pressure

  Baseline to 90 minutes

Study Arms (1)

Propofol Administration

EXPERIMENTAL

Drug: Propofol

Interventions

Propofol DRUG

Propofol administration

Propofol Administration

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Must have a body mass index (BMI) less than 30.
• Must be right handed
• Must be English speaking
• Must be capable of giving written informed consent.
• Must have history of playing tennis (or any type of racquet sport) at least 30 times over lifetime.

You may not qualify if:

• History of obstructive sleep apnea;
• History of a difficult airway with a previous anesthetic;
• History of neurological disorders;
• Hypertension or other cardiovascular abnormalities;
• Pulmonary hypertension or other pulmonary abnormalities;
• Gastroesophageal reflux disease (GERD) or heartburn;
• History of significant head injury with loss of consciousness;
• Learning disability or other developmental disorder;
• Allergic reactions to eggs;
• Pregnant or nursing mothers;
• Contraindications to neuroimaging methods;
• Inability or unwilling to fast, or withhold food and liquid intake, for 8 hours prior to your scheduled study visit.
• Unwilling to abstain from alcohol use for 24 hours prior to your scheduled study visit.
• History of drug use, or have a positive drug screen.
• Tattoos on the head or neck region - all other tattoos are subject to determination by investigators.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

Michigan Medicine - University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Amy McKinney
• Organization: University of Michigan

adrongo@med.umich.edu

734-647-8129

Study Officials

• Anthony G Hudetz, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: December 5, 2017
• Study Start: April 12, 2017
• Primary Completion: July 12, 2019
• Study Completion: July 12, 2019
• Last Updated: August 18, 2020
• Results First Posted: August 5, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)