Dose-response of Ketamine in Patient Controlled Analgesia in Orthopaedic Surgery Patients

• Status: Completed
• Trial end date: 2019-12-05
• Target enrollment: 0
• Participant gender: All

Summary

To study the multimodal protocol combining adjunct ketamine with oxycodone in intravenous patient-controlled analgesia bolus dosing and effects in patients scheduled for posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Turku University Hospital
• Collaborators: Helsinki University; University of Helsinki; University of Turku
• Treatments: Esketamine; Ketamine; Oxycodone

Criteria

Inclusion Criteria:

• 20 - 75 years of age

• Scheduled for elective posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation under general anaesthesia.

• Written informed consent from the participating patient

Exclusion Criteria:

• A previous history of intolerance to the study drug or related compounds and additives

• Concomitant drug therapy with opioids or strong CYP3A4 or CYP2B6 inductor(s) or inhibitor(s) 2 weeks prior to study.

• Patients younger than 20 years and older than 75 years.

• BMI > 35, sleep apnoea, any other sleep disorder or condition that requires treatment with continuous positive airway pressure or automatic positive airway pressure device.

• Existing significant liver or kidney disease

• History of ischemic heart disease or conduction disturbance

• History of alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent

• Donation of blood for 4 weeks prior and during the study.