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Ketamine In Thoracic Surgery (KITS) Trial (KITS)

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.
 
ClinicalTrials.gov Identifier: NCT00504725
Recruitment Status : Completed
First Posted : July 20, 2007
Results First Posted : November 16, 2012
Last Update Posted : July 25, 2014
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Lung Cancer
Interventions Drug: Ketamine
Drug: 0.9% saline
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ketamine Placebo
Hide Arm/Group Description Single bolus 0.5mg/kg ketamine IV after induction of anesthesia 0.9 % saline bolus of equivalent volume
Period Title: Overall Study
Started 21 20
Completed 20 [1] 20
Not Completed 1 0
Reason Not Completed
Protocol Violation             1             0
[1]
Prior to unblinding, one subject was discontinued due to elevated CRP levels at baseline.
Arm/Group Title Ketamine Placebo Total
Hide Arm/Group Description Single bolus 0.5mg/kg ketamine IV after induction of anesthesia 0.9 % saline bolus of equivalent volume Total of all reporting groups
Overall Number of Baseline Participants 21 20 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
AGE Number Analyzed 21 participants 20 participants 41 participants
61  (12) 66  (10) 63  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 20 participants 41 participants
Female
10
  47.6%
8
  40.0%
18
  43.9%
Male
11
  52.4%
12
  60.0%
23
  56.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants 20 participants 41 participants
21 20 41
1.Primary Outcome
Title Interleukin Levels at 24 Hours
Hide Description [Not Specified]
Time Frame 24 Hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Placebo
Hide Arm/Group Description:
Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
0.9 % saline bolus of equivalent volume
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: pg/ml
Interleukin-6 (IL-6) 245  (287) 269  (210)
Interleukin-8 (IL-8) 11.3  (12.6) 14.8  (10.8)
Interleukin-10 (IL-10) 3.0  (4.7) 4.9  (5.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ketamine, Placebo
Comments IL-6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.39
Comments We will use two way ANOVA (looking for effects due to drug and time) with a p value of 0.05 indicative of statistical significance.
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ketamine, Placebo
Comments IL-8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ketamine, Placebo
Comments IL-10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title C-reactive Protein (CRP) Serum Levels
Hide Description The CRP levels were measured 24 hours postoperatively.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Placebo
Hide Arm/Group Description:
Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
0.9 % saline bolus of equivalent volume
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: pg/ml
8.8  (4.5) 9.3  (5.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ketamine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.37
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title Verbal Pain Scores
Hide Description Pain scores rated by the subject on a scale of 0 low - 10 high
Time Frame baseline, 4 hours, 24 hours and at discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Placebo
Hide Arm/Group Description:
Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
0.9 % saline bolus of equivalent volume
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 0.30  (0.73) 0.35  (1.35)
4 Hours 3.8  (2.1) 3.1  (2.8)
24 Hours 2.6  (2.2) 2.8  (2.1)
Discharge 1.8  (2.5) 1.1  (1.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ketamine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments Baseline Pain Level Score
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ketamine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.20
Comments 4 Hour Pain Level Score
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ketamine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.37
Comments 24 Hour Pain Level Score
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Ketamine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments Pain Level Score at Discharge
Method Fisher Exact
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketamine Placebo
Hide Arm/Group Description Single bolus 0.5mg/kg ketamine IV after induction of anesthesia 0.9 % saline bolus of equivalent volume
All-Cause Mortality
Ketamine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Ketamine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/20 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ketamine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/20 (30.00%)      5/20 (25.00%)    
Cardiac disorders     
AF   3/20 (15.00%)  3 3/20 (15.00%)  3
Gastrointestinal disorders     
SMALL BOWEL OBSTRUCTION   0/20 (0.00%)  0 1/20 (5.00%)  1
Respiratory, thoracic and mediastinal disorders     
RESPIRATORY INSUFFICIENCY   2/20 (10.00%)  2 0/20 (0.00%)  0
Surgical and medical procedures     
CHEST TUBE PLACEMENT   1/20 (5.00%)  1 1/20 (5.00%)  1
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Andrew Shaw MD
Organization: Duke University Medical Center
Phone: 9192866938
EMail: andrew.shaw@duke.edu
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00504725    
Other Study ID Numbers: Pro00000895
First Submitted: July 18, 2007
First Posted: July 20, 2007
Results First Submitted: September 29, 2011
Results First Posted: November 16, 2012
Last Update Posted: July 25, 2014