Trial Outcomes & Findings for A Comparison of Intra-op Ketamine vs Placebo in Patients Having Spinal Fusion (NCT NCT02424591)

Last Updated: 2017-06-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

46 participants

Primary outcome timeframe

Post-op Day 3

Results posted on

2017-06-14

Participant Flow

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.

One patient was excluded because his surgery was cancelled.

Participant milestones

Participant milestones
Measure	Ketamine 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 placebo group will have standard of care rather than ketamine infusion Placebo: Placebo IV
Overall Study STARTED	22	23
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Ketamine 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 placebo group will have standard of care rather than ketamine infusion Placebo: Placebo IV
Overall Study Protocol Violation	2	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketamine n=20 Participants 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 n=20 Participants placebo group will have standard of care rather than ketamine infusion Placebo: Placebo IV	Total n=40 Participants Total of all reporting groups
Age, Continuous	65 years n=5 Participants	65 years n=7 Participants	65 years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	8 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	12 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants
Preoperative Opioid Use	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Prior Back Surgery	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Visual Analog Scale (VAS) Pain Score	7 points n=5 Participants	3.5 points n=7 Participants	6 points n=5 Participants
American Society of Anesthesiologists Physical Status Score I	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
American Society of Anesthesiologists Physical Status Score II	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
American Society of Anesthesiologists Physical Status Score III	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: Post-op Day 3

Outcome measures

Outcome measures
Measure	Ketamine n=20 Participants 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 n=20 Participants placebo group will have standard of care rather than ketamine infusion Placebo: Placebo IV
Scores on Questionnaires	95 points Interval 80.0 to 115.6	101 points Interval 86.0 to 109.0

SECONDARY outcome

Timeframe: Post-op Day 3

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.

Outcome measures

Outcome measures
Measure	Ketamine n=20 Participants 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 n=20 Participants placebo group will have standard of care rather than ketamine infusion Placebo: Placebo IV
Pain Score	11 points Interval 4.5 to 18.0	10.5 points Interval 8.0 to 17.0

SECONDARY outcome

Timeframe: Post-op Day 3

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

Outcome measures

Outcome measures
Measure	Ketamine n=20 Participants 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 n=20 Participants placebo group will have standard of care rather than ketamine infusion Placebo: Placebo IV
Beck's Depression Inventory	8 points Interval 5.0 to 16.0	9 points Interval 8.0 to 11.0

Adverse Events

Ketamine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

John Ard, MD

NYU School of Medicine

Phone: 212.263.5072

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place