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Pilot Study on the Effect of Dexmedetomidine on Inflammatory Responses in Patients Undergoing Lumbar Spinal Fusion

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01377623
First Posted: June 21, 2011
Last Update Posted: July 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
New York University School of Medicine
Results First Submitted: March 14, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions: Spinal Stenosis
Inflammation
Interventions: Drug: Dexmedetomidine group
Drug: Placebo group

  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
Dexmedetomidine Group (PFD) Anesthesia maintained with propofol/fentanyl/dexmedetomidine
Placebo Group (PFS) Anesthesia maintained with propofol/fentanyl/saline

Participant Flow:   Overall Study
    Dexmedetomidine Group (PFD)   Placebo Group (PFS)
STARTED   33   33 
COMPLETED   26   28 
NOT COMPLETED   7   5 



  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.
Baseline data is only available for those participants who completed the study

Reporting Groups
  Description
Placebo Group Subjects undergoing one or two level spinal fusion surgery will be screened for eligibility to participate in the study. Subject will be screened, recruited and randomized during the preadmission visit or the day of surgery. Eligible subjects will be randomized to one of the two treatment group in1:1 ratio to receive either DEX or matching placebo (PBO, LR).
Dexmedetomidine Group Fifty six subjects (28 in each arm) will be enrolled. Subjects undergoing one or two level spinal fusion surgery will be screened for eligibility to participate in the study. Subject will be screened, recruited and randomized during the preadmission visit or the day of surgery. Eligible subjects will be randomized to one of the two treatment group in1:1 ratio to receive either DEX or matching placebo (PBO, LR).
Total Total of all reporting groups

Baseline Measures
   Placebo Group   Dexmedetomidine Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 28   26   54 
Age 
[Units: Years]
Mean (Standard Deviation)
 57  (11.1)   55.3  (12.3)   56.18  (11.69) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      13  46.4%      5  19.2%      18  33.3% 
Male      15  53.6%      21  80.8%      36  66.7% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Quality of Recovery Score (QoR-40)   [ Time Frame: Post-operative Day 3 ]

2.  Secondary:   Concentration of TNF-alpha   [ Time Frame: Post-operative Day 1 ]

3.  Secondary:   Concentration of IL-1a   [ Time Frame: Post-operative Day 1 ]

4.  Secondary:   Concentration of IL-6   [ Time Frame: Post-operative Day 1 ]

5.  Secondary:   Concentration of IL-8   [ Time Frame: Post-operative Day 1 ]


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


Results Point of Contact:  
Name/Title: Alex Bekker
Organization: UMDNJ-New Jersey Medical School
phone: 973-972-5007
e-mail: alex.bekker@nyumc.org


Publications of Results:

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01377623     History of Changes
Other Study ID Numbers: 10-02185
First Submitted: January 3, 2011
First Posted: June 21, 2011
Results First Submitted: March 14, 2016
Results First Posted: December 14, 2016
Last Update Posted: July 11, 2017