Phase
Condition
Spinal Surgery
Treatment
Rectal Methadone administer during spinal surgery
Placebo: Rectal saline solution
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
18 to 65 years-old.
Elective spinal surgery with fusion of one or more sacral, lumbar, thoracic, and/orcervical levels
Capacity to provide informed consent
For participants of childbearing potential, use of contraception.
Exclusion
Exclusion Criteria:
American Society of Anesthesiologists Physical Status > IV
Hypersensitivity to the active substance (methadone hydrochloride) or other opioidanalgesics or to any ingredient in the formulation
Pregnant or nursing participants
Known or suspected mechanical gastrointestinal obstruction
Acute respiratory depression, elevated carbon dioxide levels in the blood, corpulmonale, or pulmonary disease necessitating home oxygen therapy
Acute alcohol intoxication, delirium tremens, and convulsive disorders secondary toalcohol intoxication
Severe central nervous system depression, increased intracranial pressure, or headinjury
Use of monoamine oxidase (MAO) inhibitors, such as isocarboxazid, phenelzine,selegiline, and tranylcypromine, within 14 days of enrollment
Diarrhea associated with pseudomembranous colitis caused by cephalosporins,lincomycins, or penicillins
Preoperative renal insufficiency or failure
Significant liver disease (cirrhosis or hepatic failure)
History of opioid use disorder within the last 3 months
Patients taking more than 90 mg of morphine equivalents daily
Poor comprehension of the English language
Patients who are likely to remain intubated postoperatively
QT interval > 500ms on preoperative ECG
Study Design
Study Description
Connect with a study center
St. Michael's Hospital
Toronto, Ontario M5B 1W8
CanadaActive - Recruiting
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