TerminatedPhase 4ketamine

The Effects of Ketamine and Methadone on Postoperative Pain for Laminectomy

Sponsored by Cedars-Sinai Medical Center

NCT ID
NCT02252432
Target Enrollment
13 participants
Start Date
2013-02
Est. Completion
2023-01

About This Study

The purpose of this research is to determine the pain-reducing effects of ketamine (Ketalar, an FDA-approved drug for anesthesia) and methadone (Dolophine, a long-acting narcotic) after lumbar laminectomy. The investigators would like to evaluate whether intraoperative use of both drugs may be able to provide better control of pain after lumbar surgery.

Conditions Studied

Laminectomy

Interventions

  • Ketamine
  • Methadone
  • Ketamine + methadone

Eligibility

Age:18 Years - 80 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria:

• 18 - 80 years old of either gender, scheduled for elective lumbar laminectomy

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) IV and above
* Intolerance, allergy, or contraindication to use of any medications used in this study
* Significant coronary artery disease (abnormal stress test, myocardial infarction

  * within the last 3 months)
* Increased intraocular pressure (e.g., untreated glaucoma)
* Uncontrolled hypertension (BP \> 140/90)
* Sleep apnea and currently on continuous positive airway pressure (CPAP)
* Increased intracranial pressure or clinical signs thereof
* History of intracranial surgery, stroke, or brain aneurysm
* Cardiac arrhythmias particularly prolonged QT syndrome
* Drugs known to cause prolonged qT: class (IA) antiarrhythmics (quinidine, procainamide, disopyramide), class III antiarrhythmics (sotalol, dofetilide, ibutilide, amiodarone), haloperidol, thioridazine, arsenic trioxide, HIV protease inhibitors, tricyclic antidepressants
* Individuals with significant psychological disorders including: schizophrenia, mania, bipolar disorder or psychosis
* Pregnant or lactating women
* Emergent laminectomy
* Those already receiving ketamine or methadone prior to surgery
* Morbid obesity (BMI \> 40 kg/m2) AND/OR weight \> 150 kg
* Chronic renal failure ( creatinine \> 2.0 mg/dL)
* Liver failure e.g., active cirrhosis
* Alcohol or substance abuse within in the past 3 months
* Uncorrected hypokalemia, hypomagnesemia, hypocalcemia (can be due to diuretics, mineralocorticoid use, laxatives)
* Chronic obstructive pulmonary disease (COPD)/Hypercarbia
* Restrictive lung disease (pulmonary fibrosis, myasthenia gravis)
* Congestive heart failure
* Thyroid disease
* Organ transplant patients
* Drugs/substances known to inhibit methadone metabolism: macrolide antibiotics e.g., erythromycin, cimetidine, astemizole, voriconazole, grapefruit juice

Study Locations (1)

Cedars Sinai Medical Center
Los Angeles, California, United States

This trial is not recruiting

This study is currently not accepting new participants.

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Data Source
ClinicalTrials.gov

Last updated from source