Neuroimaging the Effects of Intravenous Anesthetic on Amygdala Dependent Memory Processes

NCT00504894 | Terminated Phase 4 Results

• 2 other identifiers: 0701008933K08GM083213
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study involves 60 healthy volunteers aged between 18 and 50 recruited from the general community. It involves doing a set of simple memory tests while inside a fMRI machine. The subject is given a very low dose of an anesthetic drug intravenously while in the scanner. The subject then sees a sequence of pictures on a screen, and presses a button if they remember seeing the picture before. While this is happening, the scanner will be capturing images that tell us what parts of the brain are active. Hypothesis: patterns of hippocampal and amygdala activation during the encoding and retrieval of memory,as measured by fMRI, will be altered by intravenous anesthetics such that suppression of hippocampal and amygdala activities will be dissociable. This dissociation pattern will be different between the drugs propofol and thiopental.

Conditions

Healthy

Keywords

N/A healthy volunteers

Outcome Measures

Primary Outcomes (1)

• Blood-oxygen-level-dependent Significant Activation Cluster

  Three anatomical regions for which there was an a priori mechanistic hypothesis were assessed using standard small volume correction: (i) the amygdala, bilaterally; (ii) the hippocampus, bilaterally; and (iii) the parahippocampus, bilaterally. Using single-tailed t tests, a priori regions were reported as significant if the initial uncorrected voxel-wise P value was \< 0.001, and then the P value was \< 0.05 after family-wise error correction for multiple comparisons in the hypothesized anatomical region. For non-hypothesized regions outside the medial temporal lobe, findings were reported as significant if the initial uncorrected voxel-wise P value was \< 0.001, and then the P value was \< 0.05 after family-wise error correction for multiple comparisons across the whole brain. Clusters containing voxel maxima at these thresholds are reported.

  for 90 minutes after the drug/placebo was commenced

Secondary Outcomes (1)

• Blood-oxygen-level-dependent Significant Activation Cluster for Positive Sequential Memory

  for 90 minutes after the drug/placebo was commenced

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo given in low dose to gauge subject's responses to visual stimuli.

Drug: Placebo

Propofol

ACTIVE COMPARATOR

Propofol given at 0.90 μgml-1 to gauge subject's responses to visual stimuli.

Drug: Propofol

Thiopental

ACTIVE COMPARATOR

Thiopental given at 3.0 μgml-1 to gauge subject's responses to visual stimuli.

Drug: Thiopental

Interventions

Placebo DRUG

A low dose given intravenously one time for just under an hour while the subject is shown visually stimulating images in an MRI machine.

Placebo

Propofol DRUG

A low dose of propofol 0.90 μgml-1, given intravenously while the subject is shown visually stimulating images in an MRI machine.

Propofol

Thiopental DRUG

A low dose of thiopental 3.0 μgml-1, given intravenously while the subject is shown visually stimulating images in an MRI machine.

Thiopental

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age b/w 18 and 50
• right-handed
• minimum of high school education
• fluent in English
• normal vocabulary

You may not qualify if:

• any significant medical/psychiatric comorbidity
• deficit in vision or hearing that would impede the study
• allergies to any of the study drugs, to soybeans, or eggs.
• history of head trauma
• family history of major psychiatric illness
• body mass index \> 30 kg/m2
• claustrophobia
• prior exposure to IAPS pictures
• pregnancy
• permanent metal objects anywhere in the body
• a personal/family history of any porphyria

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Institutes of Health (NIH): collaborator
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Related Publications (1)

• Pryor KO, Root JC, Mehta M, Stern E, Pan H, Veselis RA, Silbersweig DA. Effect of propofol on the medial temporal lobe emotional memory system: a functional magnetic resonance imaging study in human subjects. Br J Anaesth. 2015 Jul;115 Suppl 1(Suppl 1):i104-i113. doi: 10.1093/bja/aev038.

  PMID: 26174294 DERIVED

MeSH Terms

Interventions

Propofol; Thiopental

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Thiobarbiturates; Barbiturates; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Kane Pryor
• Organization: Weill Cornell Medicine

kap9009@med.cornell.edu

(212) 746-2953

Study Officials

• Kane Pryor, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2007
• First Posted: July 20, 2007
• Study Start: March 1, 2007
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: July 15, 2021
• Results First Posted: May 18, 2017

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)