Dose Response Study of Dexmedetomidine in Orthopaedic Spine Surgery Patients

NCT ID: NCT02454881

Last Updated: 2020-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2020-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Oxycodone 1 mg / ml alone

Group Type ACTIVE_COMPARATOR

Oxycodone

Intervention Type DRUG

Dexmedetomidine 2.5

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

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

Oxycodone

Intervention Type DRUG

Dexmedetomidine 5

Oxycodone 1 mg / mL + Dexmedetomidine 5 μg / mL

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

Oxycodone

Intervention Type DRUG

Dexmedetomidine 10

Oxycodone 1 mg / mL + Dexmedetomidine 10 μg / mL

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

Oxycodone

Intervention Type DRUG

Interventions

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Dexmedetomidine

Intervention Type DRUG

Oxycodone

Intervention Type DRUG

Other Intervention Names

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Dexdor Oxanest

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Helsinki

OTHER

Sponsor Role collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Teijo I Saari, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dept. Anaesthesiology and Intensive Care, University Of Turku

Locations

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

Turku, , Finland

Site Status

Countries

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Finland

Other Identifiers

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T97/2015

Identifier Type: -

Identifier Source: org_study_id

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