search
Back to results

Dose Response Study of Dexmedetomidine in Orthopaedic Spine Surgery Patients (DoserespDex)

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Dexmedetomidine
Oxycodone
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

Dexmedetomidine 2.5

Dexmedetomidine 5

Dexmedetomidine 10

Arm Description

Oxycodone 1 mg / ml alone

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

Oxycodone 1 mg / mL + Dexmedetomidine 5 μg / mL

Oxycodone 1 mg / mL + Dexmedetomidine 10 μg / mL

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in numerical rating scale (NRS 0-10)
Number of patients with numerical rating scale value under 3
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Efficacy of dexmedetomidine as an adjuvant in postoperative analgesia with oxycodone after spinal surgery

Full Information

First Posted
May 20, 2015
Last Updated
September 21, 2020
Sponsor
Turku University Hospital
Collaborators
University of Helsinki
search

1. Study Identification

Unique Protocol Identification Number
NCT02454881
Brief Title
Dose Response Study of Dexmedetomidine in Orthopaedic Spine Surgery Patients
Acronym
DoserespDex
Official Title
Dose Response Study of Patient Controlled Analgesia (PCA) of Dexmedetomidine in Orthopaedic Spine Surgery Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
October 31, 2019 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Turku University Hospital
Collaborators
University of Helsinki

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Active Comparator
Arm Description
Oxycodone 1 mg / ml alone
Arm Title
Dexmedetomidine 2.5
Arm Type
Active Comparator
Arm Description
Oxycodone 1 mg / mL + Dexmedetomidine 2,5 μg / mL
Arm Title
Dexmedetomidine 5
Arm Type
Active Comparator
Arm Description
Oxycodone 1 mg / mL + Dexmedetomidine 5 μg / mL
Arm Title
Dexmedetomidine 10
Arm Type
Active Comparator
Arm Description
Oxycodone 1 mg / mL + Dexmedetomidine 10 μg / mL
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Dexdor
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Other Intervention Name(s)
Oxanest
Primary Outcome Measure Information:
Title
Change in opioid consumption (mg) postoperatively
Description
Change from baseline opioid consumption (mg) postoperatively at 24 hours
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Change in numerical rating scale (NRS 0-10)
Description
Number of patients with numerical rating scale value under 3
Time Frame
72 hours
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Description
Efficacy of dexmedetomidine as an adjuvant in postoperative analgesia with oxycodone after spinal surgery
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teijo I Saari, MD, PhD
Organizational Affiliation
Dept. Anaesthesiology and Intensive Care, University Of Turku
Official's Role
Principal Investigator
Facility Information:
Facility Name
Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital
City
Turku
ZIP/Postal Code
20521
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Dose Response Study of Dexmedetomidine in Orthopaedic Spine Surgery Patients

We'll reach out to this number within 24 hrs