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Anesthesia and Functional Connectivity: An Analysis of fMRI Changes

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ClinicalTrials.gov Identifier: NCT02196259
Recruitment Status : Terminated (Funding cessation.)
First Posted : July 22, 2014
Results First Posted : May 2, 2017
Last Update Posted : May 2, 2017
Sponsor:
Information provided by (Responsible Party):
Scott Peltier, University of Michigan

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition: Changes in Brain Network Connectivity
Intervention: Drug: Anesthetics, Dissociative

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
3 participants were screened out.

Reporting Groups
  Description
Initial MRI

The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)

Anesthetics, Dissociative: The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)

Hospital No text entered.
Depresssion No text entered.

Participant Flow:   Overall Study
    Initial MRI   Hospital   Depresssion
STARTED   3   7   3 
COMPLETED   3   4   2 
NOT COMPLETED   0   3   1 
Researcher choice                0                0                1 
Partial data analysis                0                3                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Initial MRI

The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)

Anesthetics, Dissociative: The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)

Initial Hospital The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)
Depression The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)
Total Total of all reporting groups

Baseline Measures
   Initial MRI   Initial Hospital   Depression   Total 
Overall Participants Analyzed 
[Units: Participants]
 3   7   3   13 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      3 100.0%      7 100.0%      3 100.0%      13 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      1  33.3%      1  14.3%      0   0.0%      2  15.4% 
Male      2  66.7%      6  85.7%      3 100.0%      11  84.6% 
Region of Enrollment 
[Units: Participants]
       
United States   3   7   3   13 


  Outcome Measures

1.  Primary:   Functional Connectivity   [ Time Frame: 8 minutes scans, acquired between 1 day and 3 days (see above) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
These data should be interpreted with caution because of the small sample size due to the nature of this pilot study.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Scott Peltier
Organization: University of Michigan
phone: 734-647-8077
e-mail: spelt@umich.edu


Publications:


Responsible Party: Scott Peltier, University of Michigan
ClinicalTrials.gov Identifier: NCT02196259     History of Changes
Other Study ID Numbers: U028860-MICHR-Pilot
First Submitted: July 17, 2014
First Posted: July 22, 2014
Results First Submitted: May 31, 2016
Results First Posted: May 2, 2017
Last Update Posted: May 2, 2017