Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

A Comparison of Intra-op Ketamine vs Placebo in Patients Having Spinal Fusion

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: NCT02424591
Recruitment Status : Completed
First Posted : April 23, 2015
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Other
Condition Postoperative Pain
Interventions Drug: Ketamine
Other: Placebo
Enrollment 46
Recruitment Details Patients were approached either at pre-admission testing or at the peri-op area of the hospital. All patients were spoken to privately and given time to ask questions. After consent was signed, a copy was given to the subject and a copy put into the medical record.
Pre-assignment Details One patient was excluded because his surgery was cancelled.
Arm/Group Title Ketamine Placebo
Hide Arm/Group Description

ketamine group will be infused after intubation and terminated at the start of skin closure

Ketamine: Infusion at a rate of 10 mcg/kg/min

placebo group will have standard of care rather than ketamine infusion

Placebo: Placebo IV

Period Title: Overall Study
Started 22 23
Completed 20 20
Not Completed 2 3
Reason Not Completed
Protocol Violation             2             3
Arm/Group Title Ketamine Placebo Total
Hide Arm/Group Description

ketamine group will be infused after intubation and terminated at the start of skin closure

Ketamine: Infusion at a rate of 10 mcg/kg/min

placebo group will have standard of care rather than ketamine infusion

Placebo: Placebo IV

Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
65
(56 to 72)
65
(53 to 72)
65
(54 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
12
  60.0%
8
  40.0%
20
  50.0%
Male
8
  40.0%
12
  60.0%
20
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 20 participants 40 participants
20 20 40
Preoperative Opioid Use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
9
  45.0%
8
  40.0%
17
  42.5%
Prior Back Surgery  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
11
  55.0%
13
  65.0%
24
  60.0%
Visual Analog Scale (VAS) Pain Score   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Points
Number Analyzed 20 participants 20 participants 40 participants
7
(5 to 8)
3.5
(2.8 to 7.0)
6
(3 to 8)
[1]
Measure Description: The Visual Analog Scale is a way to measure pain, with zero being no pain at all and 10 being the most terrible pain.
American Society of Anesthesiologists Physical Status Score   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
I
0
   0.0%
1
   5.0%
1
   2.5%
II
10
  50.0%
8
  40.0%
18
  45.0%
III
10
  50.0%
11
  55.0%
21
  52.5%
[1]
Measure Description:

The American Society of Anesthesiologists Physical Status Score is assigned by the anesthesiologist at the time of providing care, based on the following definitions:

ASA I - A normal healthy patient ASA II - A patient with mild systemic disease ASA III - A patient with severe systemic disease ASA IV - A patient with severe systemic disease that is a constant threat to life ASA V - A moribund patient who is not expected to survive without the operation ASA VI - A declared brain-dead patient whose organs are being removed for donor purposes

1.Primary Outcome
Title Scores on Questionnaires
Hide Description Quality of Recovery 15 questions questionnaires that ask, on a scale of 0-10, with 0 always being bad and 10 always being best, how the patient is recovering. The total number is reviewed, so the highest total score possible is 150 and the lowest is 0.
Time Frame Post-op Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Placebo
Hide Arm/Group Description:

ketamine group will be infused after intubation and terminated at the start of skin closure

Ketamine: Infusion at a rate of 10 mcg/kg/min

placebo group will have standard of care rather than ketamine infusion

Placebo: Placebo IV

Overall Number of Participants Analyzed 20 20
Median (Inter-Quartile Range)
Unit of Measure: points
95
(80 to 115.6)
101
(86 to 109)
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 0.86
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Pain Score
Hide Description

McGill Short Form measures pain in different ways. The first part of the form lists 15 adjectives for pain, for which the answers can be none (0), Mild (1), Moderate (2) and Severe (3). Descriptors 1-11 represent the sensory dimension of pain experience and 12-15 represent the affective dimension. A score of 0 is good, and a score of 45 indicates extreme pain. The lower the score the less pain a subject feels (better), as the scores go up, so do the pain levels (worse).

PPI (Present Pain Intensity) asks patients to measure pain from 0 (no pain) to 5 (excruciating). Again, a lower score is ideal.

Time Frame Post-op Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Placebo
Hide Arm/Group Description:

ketamine group will be infused after intubation and terminated at the start of skin closure

Ketamine: Infusion at a rate of 10 mcg/kg/min

placebo group will have standard of care rather than ketamine infusion

Placebo: Placebo IV

Overall Number of Participants Analyzed 20 20
Median (Inter-Quartile Range)
Unit of Measure: points
11
(4.5 to 18)
10.5
(8 to 17)
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 0.79
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Beck's Depression Inventory
Hide Description

Beck's Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures attitudes and symptoms of depression. Each sentence has a rating from 0 to 3 and the sentences go from mild to fairly severe descriptions of moods. The numbers are tabulated, the lowest possible score is 0 and the highest is 63.

A score of 1-10 indicates normal ups and downs. 11-16 indicates a mild mood disturbance; 17-20, borderline clinical depression; 21-30, moderate depression; 31-40, severe depression; over 40, extreme depression

Time Frame Post-op Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Placebo
Hide Arm/Group Description:

ketamine group will be infused after intubation and terminated at the start of skin closure

Ketamine: Infusion at a rate of 10 mcg/kg/min

placebo group will have standard of care rather than ketamine infusion

Placebo: Placebo IV

Overall Number of Participants Analyzed 20 20
Median (Inter-Quartile Range)
Unit of Measure: points
8
(5 to 16)
9
(8 to 11)
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 0.74
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame Data was reviewed for adverse events intraoperative through post-op day 3.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketamine Placebo
Hide Arm/Group Description

ketamine group will be infused after intubation and terminated at the start of skin closure

Ketamine: Infusion at a rate of 10 mcg/kg/min

placebo group will have standard of care rather than ketamine infusion

Placebo: Placebo IV

All-Cause Mortality
Ketamine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Ketamine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ketamine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: John Ard, MD
Organization: NYU School of Medicine
Phone: 212.263.5072
EMail: john.ard@nyumc.org
Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02424591    
Other Study ID Numbers: 14-00599
First Submitted: April 2, 2015
First Posted: April 23, 2015
Results First Submitted: December 5, 2016
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017