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Completed

NCT Number: NCT02454881

Dose Response Study of Dexmedetomidine in Orthopaedic Spine Surgery Patients

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.

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Key information

Conditions

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

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Turku, 20521, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

Other names: Dexdor

Oxycodone

Drug

Other names: Oxanest

Primary outcomes

  1. Change in opioid consumption (mg) postoperatively

    Time frame: 24 hours

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

Secondary outcomes

  1. Change in numerical rating scale (NRS 0-10)

    Time frame: 72 hours

    Number of patients with numerical rating scale value under 3

  2. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Time frame: 72 hours

    Efficacy of dexmedetomidine as an adjuvant in postoperative analgesia with oxycodone after spinal surgery

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Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Collaborators

  • University of Helsinki

Registry information

Official study title

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

Acronym: DoserespDex

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
May 27, 2015
Registry last updated
Sep 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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