Dose-response of ketamine in patient controlled analgesia in orthopaedic surgery patients

Dose response study of Patient Controlled Analgesia (PCA) of S-ketamine in orthopaedic spine surgery patients - DoseRespKeta

Status

Active, not recruiting

Phases

Phase 1Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002887-14-FI

Enrollment

100

Registered

2016-10-14

Start date

2016-10-31

Completion date

Unknown

Last updated

2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients who are scheduled for elective posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation MedDRA version: 19.0 Level: LLT Classification code 10041595 Term: Spinal stenosis lumbar System Organ Class: 100000004859

Interventions

Trade Name: Ketanest-S Pharmaceutical Form: Injection INN or Proposed INN: KETAMINE CAS Number: 6740-88-1 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration numb

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 20 - 75 years of age 2. Scheduled for elective posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation under general anaesthesia. 3. Written informed consent from the participating patient 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 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: 1. A previous history of intolerance to the study drug or related compounds and additives 2. Concomitant drug therapy with opioids or strong CYP3A4 or CYP2B6 inductor(s) or inhibitor(s) 2 weeks prior to study. 3. Patients younger than 20 years and older than 75 years. 4. BMI > 35, sleep apnoea, any other sleep disorder or condition that requires treatment with continuous positive airway pressure or automatic positive a irway pressure device. 5. Existing significant liver or kidney disease 6. History of ischemic heart disease or conduction disturbance 7. History of alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent 8. Donation of blood for 4 weeks prior and during the study.

Design outcomes

Primary

Measure	Time frame
Main Objective: This randomized, double-blinded, controlled study is aimed to study the dose-response using combining adjunct S-ketamine with oxycodone in intravenous PCA bolus dosing in patients scheduled for posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation. ;Secondary Objective: Building a pharmacokinetic-pharmacodynamic model for S-ketamine and oxycodone;Primary end point(s): All planned blood samples have been drawn;Timepoint(s) of evaluation of this end point: 72 h after the end of surgery	—

Measure

Time frame

Main Objective: This randomized, double-blinded, controlled study is aimed to study the dose-response using combining adjunct S-ketamine with oxycodone in intravenous PCA bolus dosing in patients scheduled for posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation. ;Secondary Objective: Building a pharmacokinetic-pharmacodynamic model for S-ketamine and oxycodone;Primary end point(s): All planned blood samples have been drawn;Timepoint(s) of evaluation of this end point: 72 h after the end of surgery

—

Secondary

Measure	Time frame
Secondary end point(s): All pain measurements have been recorded;Timepoint(s) of evaluation of this end point: 72 hours after the end of surgery	—

Countries

Finland

Contacts

Public ContactTurku Clinical Research Centre

Turku University Hospital

turkucrc@tyks.fi

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026