Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Brief Summary:

Postoperative pain is severe after major spine surgery. Opioids such as morphine and hydromorphone are routinely used for postoperative pain control. These drugs have significant side effects, most importantly respiratory depression, nausea, constipation and tolerance. Moreover, many spine surgery patients have used opioid pain medication for back pain long term, leading to pre-surgical opioid tolerance and increased postoperative pain. This has led to a search for adjuvant medications to reduce the use of opioids and reduce opioid mediated side effects and tolerance.

Ketamine is an intravenous anesthetic with analgesic properties in subanesthetic doses. Ketamine is a noncompetitive antagonist of N-methyl-D-aspartate (NMDA) receptors. NMDA receptors are involved in central pain sensitization via wind-up phenomenon and altered pain memory, a process which can be blocked by ketamine. NMDA receptor antagonists may prevent the development of tolerance to opioids and hyperalgesia. Ketamine has been safely used to decrease pain in numerous studies. Ketamine can also act as an antidepressant with hours of administration.

Ketamine has rapid brain uptake and subsequent re-distribution with a distribution half-life of 10-15 minutes and an elimination half-life of 2 hours. Ketamine does not cause respiratory depression.


Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Ketamine Other: Placebo Phase 4

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: A Prospective, Randomized, Single Blinded Comparison of Intraoperative Ketamine Infusion Versus Placebo in Patients Having Spinal Fusion
Study Start Date : August 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Active Comparator: Ketamine
ketamine group will be infused after intubation and terminated at the start of skin closure
Drug: Ketamine
Infusion at a rate of 10 mcg/kg/min
Other Name: Ketalar

Placebo Comparator: Placebo
placebo group will have standard of care rather than ketamine infusion
Other: Placebo
Placebo IV




Primary Outcome Measures :
  1. Scores on Questionnaires [ Time Frame: Post-op Day 3 ]
    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.


Secondary Outcome Measures :
  1. Pain Score [ Time Frame: 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.


  2. Beck's Depression Inventory [ Time Frame: 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




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult (>/=18)
  2. male or female
  3. Undergoing surgery for multilevel (>2 level) spinal fusion from a posterior approach.
  4. General anesthesia
  5. English speakers such that they can complete the pain score and satisfaction questionnaires whose scores are a critical outcome variable.
  6. If female, subject is non-lactating and is either: a. Post-menopausal or post hysterectomy; b. Of childbearing potential but is not pregnant at time of baseline as determined by pre-surgical pregnancy testing.
  7. Subject is American Society of Anesthesiologists (ASA) physical status 1, 2, or 3.

Exclusion Criteria:

  1. Cognitively impaired (by history)
  2. Subject with a history of psychosis
  3. Subject known to have significant hepatic disease
  4. Subject for whom opioids or ketamine are contraindicated
  5. Patients with narrow angle glaucoma
  6. Increased intracranial or intraocular pressure
  7. If female, is either pregnant or lactating.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02424591


Locations
Layout table for location information
United States, New York
NYU School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
Layout table for investigator information
Principal Investigator: John Ard, MD NYU School of Medicine

Publications:
Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02424591     History of Changes
Other Study ID Numbers: 14-00599
First Posted: April 23, 2015    Key Record Dates
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by NYU Langone Health:
Anesthesia Recovery Period
Spinal Fusion
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action