Pain, Postoperative Clinical Trial
— DoserespDexOfficial title:
Dose Response Study of Patient Controlled Analgesia (PCA) of Dexmedetomidine in Orthopaedic Spine Surgery Patients
NCT number | NCT02454881 |
Other study ID # | T97/2015 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | June 2015 |
Est. completion date | March 1, 2020 |
Verified date | September 2020 |
Source | Turku University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To study the multimodal protocol combining adjunct dexmedetomidine with oxycodone in intravenous patient-controlled analgesia bolus dosing and effects in patients scheduled for posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation.
Status | Completed |
Enrollment | 107 |
Est. completion date | March 1, 2020 |
Est. primary completion date | October 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Scheduled for elective posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation under general anaesthesia. - Written informed consent from the participating subject Exclusion Criteria: - A previous history of intolerance to the study drug or related compounds and additives - Concomitant drug therapy with oxycodone or buprenorphine. - History of ischemic heart disease or conduction disturbance - BMI > 35 - Existing significant haematological, endocrine, metabolic or gastrointestinal disease - History of alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent - Allergy to dexmedetomidine or oxycodone - Blood loss exceeding 1500 ml during operation |
Country | Name | City | State |
---|---|---|---|
Finland | Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital | Turku |
Lead Sponsor | Collaborator |
---|---|
Turku University Hospital | University of Helsinki |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in opioid consumption (mg) postoperatively | Change from baseline opioid consumption (mg) postoperatively at 24 hours | 24 hours | |
Secondary | Change in numerical rating scale (NRS 0-10) | Number of patients with numerical rating scale value under 3 | 72 hours | |
Secondary | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Efficacy of dexmedetomidine as an adjuvant in postoperative analgesia with oxycodone after spinal surgery | 72 hours |
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