- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02994173
Dose-response of Ketamine in Patient Controlled Analgesia in Orthopaedic Surgery Patients (DoseRespKeta)
December 10, 2019 updated by: Turku University Hospital
Dose Response Study of Patient Controlled Analgesia (PCA) of S-ketamine in Orthopaedic Spine Surgery Patients
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Turku, Finland, 20521
- Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Placebo
Oxycodone 1 mg / ml alone
|
Current clinical practice, used as a control in this study
Other Names:
|
Active Comparator: Ketamine 0.25
Oxycodone 1 mg / ml + S-ketamine 0.25 mg / ml (ratio 1:0.25)
|
dosage
Other Names:
|
Active Comparator: Ketamine 0.5
Oxycodone 1 mg / ml + S-ketamine 0.5 mg / ml (ratio 1:0.5)
|
dosage
Other Names:
|
Active Comparator: Ketamine 0.75
Oxycodone 1 mg / ml + S-ketamine 0.75 mg / ml (ratio 1:0.75)
|
dosage
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in opioid consumption (mg) postoperatively
Time Frame: 24 and 72 hours
|
Change from baseline opioid consumption (mg) postoperatively at 24 and 72 hours
|
24 and 72 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in numerical rating scale (NRS 0-10)
Time Frame: 24 and 72 hours
|
Change from baseline NRS value postoperatively at 24 and 72 hours
|
24 and 72 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marko Peltoniemi, MD, PhD, Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2017
Primary Completion (Actual)
November 3, 2019
Study Completion (Actual)
December 5, 2019
Study Registration Dates
First Submitted
November 3, 2016
First Submitted That Met QC Criteria
December 13, 2016
First Posted (Estimate)
December 15, 2016
Study Record Updates
Last Update Posted (Actual)
December 11, 2019
Last Update Submitted That Met QC Criteria
December 10, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Analgesics, Opioid
- Narcotics
- Psychotropic Drugs
- Antidepressive Agents
- Ketamine
- Esketamine
- Oxycodone
Other Study ID Numbers
- T281/2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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