adult patients undergoing spinal surgery MedDRA version: 14.1 Level: LLT Classification code 10041595 Term: Spinal stenosis lumbar System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Adult patients undergoing elective posterior lumbar fusion surgery volunteering for the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 192 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: BMI>35, unstable ischaemic cardiac disease, increased intracranial pressure, increased intraocular pressure, gravidity, lactation, hypersensitivity or allergy to ketamine, oxycodone, propofol or remifentanil, severe psychiatric disease, unwillingness or unability to use PCA-device, unability to use NRS-pain scale
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to reduce the need of opioids after surgery;Secondary Objective: to reduce postoperative confusion, pain, depression;Primary end point(s): consumption of oxycodone with PCA-device 48 hours after the surgery;Timepoint(s) of evaluation of this end point: 48 hours after the surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): confusion in the postoperative care unit, pain, depression ; Timepoint(s) of evaluation of this end point: confusion in the postoperative care unit approximately 4 hours pain 48 hours after surgery, 3 months after surgery and 24 after surgery depression before surgery and 3 months after surgery | — |
Countries
Finland
Contacts
Helsinki University Hospital