Ketamine Infusion and Hypoventilation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gildasio De Oliveira, Northwestern University
ClinicalTrials.gov Identifier:
NCT01535976
First received: September 9, 2011
Last updated: February 18, 2014
Last verified: February 2014
Results First Received: November 11, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Condition: Hypoventilation
Interventions: Drug: Placebo
Drug: Ketamine

  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
Hospital based recruitment. From August 2011 to June 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ketamine

Infusion of ketamine

Ketamine : Ketamine infusion .5mg/kg bolus followed by 1.5 mcg/kg/minute until end of case

Placebo

.9 normal saline infusion

Placebo : Placebo Comparator: Placebo

.9 normal saline infusion


Participant Flow:   Overall Study
    Ketamine     Placebo  
STARTED     27     27  
COMPLETED     26     26  
NOT COMPLETED     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.
No text entered.

Reporting Groups
  Description
Ketamine

Infusion of ketamine

Ketamine : Ketamine infusion .5mg/kg bolus followed by 1.5 mcg/kg/minute until end of case along with propofol 100 mcg/kg/min

Placebo

normal saline infusion

Placebo : Placebo Comparator: Placebo

normal saline infusion along with propofol 100 mcg/kg/min

Total Total of all reporting groups

Baseline Measures
    Ketamine     Placebo     Total  
Number of Participants  
[units: participants]
  27     27     54  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     27     27     54  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  48.4  ± 7.67     46.89  ± 7.35     47.65  ± 7.55  
Gender  
[units: participants]
     
Female     27     27     54  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     27     27     54  



  Outcome Measures

1.  Primary:   Intraoperative Hypoventilation   [ Time Frame: 8 hours ]


  Serious Adverse Events


  Other Adverse Events


  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.


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
We did not use depth of anesthesia monitor guided protocol due to controversial effects of ketamine of the correlation of processed EEG monitor and clinical levels of sedation. We did not use opioids as part of the protocol.  


Results Point of Contact:  
Name/Title: Gildasio De Oliveira MD
Organization: Northwestern University
phone: 312-472-3573
e-mail: g-jr@northwestern.edu


No publications provided


Responsible Party: Gildasio De Oliveira, Northwestern University
ClinicalTrials.gov Identifier: NCT01535976     History of Changes
Other Study ID Numbers: STU00048723
Study First Received: September 9, 2011
Results First Received: November 11, 2013
Last Updated: February 18, 2014
Health Authority: United States: Institutional Review Board