Dose Response Study of Dexmedetomidine in Orthopaedic Spine Surgery Patients

NCT02454881 | Completed Phase 4

• 1 other identifier: T97/2015
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Change in opioid consumption (mg) postoperatively

  Change from baseline opioid consumption (mg) postoperatively at 24 hours

  24 hours

Secondary Outcomes (2)

• 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

Study Arms (4)

Placebo

ACTIVE COMPARATOR

Oxycodone 1 mg / ml alone

Drug: Oxycodone

Dexmedetomidine 2.5

ACTIVE COMPARATOR

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

Drug: Dexmedetomidine; Drug: Oxycodone

Dexmedetomidine 5

ACTIVE COMPARATOR

Oxycodone 1 mg / mL + Dexmedetomidine 5 μg / mL

Drug: Dexmedetomidine; Drug: Oxycodone

Dexmedetomidine 10

ACTIVE COMPARATOR

Oxycodone 1 mg / mL + Dexmedetomidine 10 μg / mL

Drug: Dexmedetomidine; Drug: Oxycodone

Interventions

Dexmedetomidine DRUG

Also known as: Dexdor

Dexmedetomidine 10; Dexmedetomidine 2.5; Dexmedetomidine 5

Oxycodone DRUG

Also known as: Oxanest

Dexmedetomidine 10; Dexmedetomidine 2.5; Dexmedetomidine 5; Placebo

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled for elective posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation under general anaesthesia.
• Written informed consent from the participating subject

You may not qualify if:

• 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

Sponsors & Collaborators

• Turku University Hospital: lead
• University of Helsinki: collaborator

Study Sites (1)

Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital

Turku, 20521, Finland

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexmedetomidine; Oxycodone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Teijo I Saari, MD, PhD

  Dept. Anaesthesiology and Intensive Care, University Of Turku

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2015
• First Posted: May 27, 2015
• Study Start: June 1, 2015
• Primary Completion: October 31, 2019
• Study Completion: March 1, 2020
• Last Updated: September 22, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)