Dose Response Study of Dexmedetomidine in Orthopaedic Spine Surgery Patients

Dose Response Study of Patient Controlled Analgesia (PCA) of Dexmedetomidine in Orthopaedic Spine Surgery Patients

Sponsors

Lead Sponsor: Turku University Hospital

Collaborator: University of Helsinki

Source Turku University Hospital
Brief Summary

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.

Overall Status Recruiting
Start Date June 2015
Completion Date December 2020
Primary Completion Date June 12, 2020
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in opioid consumption (mg) postoperatively 24 hours
Secondary Outcome
Measure Time Frame
Change in numerical rating scale (NRS 0-10) 72 hours
Number of Participants with Adverse Events as a Measure of Safety and Tolerability 72 hours
Enrollment 100
Condition
Intervention

Intervention Type: Drug

Intervention Name: Dexmedetomidine

Other Name: Dexdor

Intervention Type: Drug

Intervention Name: Oxycodone

Other Name: Oxanest

Eligibility

Criteria:

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

Gender: All

Minimum Age: 20 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Teijo I Saari, MD, PhD Principal Investigator Dept. Anaesthesiology and Intensive Care, University Of Turku
Overall Contact

Last Name: Teijo I Saari, MD, PhD

Phone: +35823130671

Email: [email protected]

Location
Facility: Status: Contact: Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital Teijo I Saari, MD, PhD +3582313000 [email protected]
Location Countries

Finland

Verification Date

March 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Placebo

Type: Active Comparator

Description: Oxycodone 1 mg / ml alone

Label: Dexmedetomidine 2.5

Type: Active Comparator

Description: Oxycodone 1 mg / mL + Dexmedetomidine 2,5 μg / mL

Label: Dexmedetomidine 5

Type: Active Comparator

Description: Oxycodone 1 mg / mL + Dexmedetomidine 5 μg / mL

Label: Dexmedetomidine 10

Type: Active Comparator

Description: Oxycodone 1 mg / mL + Dexmedetomidine 10 μg / mL

Acronym DoserespDex
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov