Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2025-12-24 @ 9:47 PM
NCT ID:
NCT02252432
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02252432
Study Brief:
Protocol Section:
NCT02252432