Status:
TERMINATED
The Effects of Ketamine and Methadone on Postoperative Pain for Laminectomy
Lead Sponsor:
Cedars-Sinai Medical Center
Conditions:
Laminectomy
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
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 laminec...
Detailed Description
During and after the surgery, patients undergoing surgery most likely need narcotics (opioids) that can cause side effects such as drowsiness and constipation. This can delay your recovery. The invest...
Eligibility Criteria
Inclusion
- • 18 - 80 years old of either gender, scheduled for elective lumbar laminectomy
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2023
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT02252432
Start Date
February 1 2013
End Date
January 1 2023
Last Update
February 29 2024
Active Locations (1)
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1
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048