Use of Ketamine vs Methohexital for Electroconvulsive Therapy (ECT) on Patient Recovery and Re-orientation Time

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of New Mexico
ClinicalTrials.gov Identifier:
NCT01567852
First received: March 28, 2012
Last updated: December 15, 2014
Last verified: June 2014
Results First Received: May 21, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Post-anesthesia Recovery
Orientation
Interventions: Drug: Ketamine
Drug: Methohexital

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Ketamine Then Methohexital (Alternating Each Trial)

This arm will receive ketamine for induction first, followed by alternating treatments between methohexital and ketamine. Each induction is counted as one trial. Each trial is followed by a day of no treatment (2 days for weekends).

Ketamine: Ketamine (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect

Methohexital: Methohexital (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect

Methohexital Then Ketamine (Alternating Each Trial)

This arm will receive Methohexital first for induction, followed by alternating treatments between ketamine and methohexital. Each induction is one trial. Each trial is followed by one day of no treatment (2 days for weekends).

Ketamine: Ketamine (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect

Methohexital: Methohexital (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect


Participant Flow:   Overall Study
    Ketamine Then Methohexital (Alternating Each Trial)     Methohexital Then Ketamine (Alternating Each Trial)  
STARTED     8     12  
COMPLETED     4     5  
NOT COMPLETED     4     7  
Withdrawal by Subject                 3                 6  
ECT discontinued                 1                 1  



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Ketamine First

This arm will receive ketamine for induction first, followed by alternating treatments between methohexital and ketamine

Ketamine: Ketamine (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect

Methohexital: Methohexital (1-1.5mg/kg) will be given for induction

Methohexital First

This arm will receive Methohexital first for induction, followed by alternating treatments between ketamine and methohexital.

Ketamine: Ketamine (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect

Methohexital: Methohexital (1-1.5mg/kg) will be given for induction

Total Total of all reporting groups

Baseline Measures
    Ketamine First     Methohexital First     Total  
Number of Participants  
[units: participants]
  8     12     20  
Age  
[units: years]
Mean (Standard Deviation)
  51.75  (13.46)     54  (22.63)     52.65  (17.17)  
Gender  
[units: participants]
     
Female     5     7     12  
Male     3     5     8  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     0     0  
White     8     11     19  
More than one race     0     0     0  
Unknown or Not Reported     0     1     1  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     2     3     5  
Not Hispanic or Latino     6     8     14  
Unknown or Not Reported     0     1     1  



  Outcome Measures
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1.  Primary:   Re-orientation Time   [ Time Frame: 1 hour ]

2.  Primary:   Recovery Time   [ Time Frame: 1 hour ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Tony Yen
Organization: University of NewMexico
phone: 505-272-2610
e-mail: tyen@salud.unm.edu


No publications provided


Responsible Party: University of New Mexico
ClinicalTrials.gov Identifier: NCT01567852     History of Changes
Other Study ID Numbers: HRRC#: 11-236
Study First Received: March 28, 2012
Results First Received: May 21, 2014
Last Updated: December 15, 2014
Health Authority: United States: Institutional Review Board