Dose Response Study of Dexmedetomidine in Orthopaedic Spine Surgery Patients

Pain, Postoperative Clinical Trial

— DoserespDex  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02454881
• Other study ID #: T97/2015
• Status: Completed
• Phase: Phase 4
• Start date: June 2015
• Est. completion date: March 1, 2020

Study information

• Verified date: September 2020
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: March 1, 2020
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Dexmedetomidine

• Oxycodone

Locations

Country	Name	City	State
Finland	Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital	Turku

Sponsors (2)

Lead Sponsor	Collaborator
Turku University Hospital	University of Helsinki

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in opioid consumption (mg) postoperatively	Change from baseline opioid consumption (mg) postoperatively at 24 hours	24 hours
Secondary	Change in numerical rating scale (NRS 0-10)	Number of patients with numerical rating scale value under 3	72 hours
Secondary	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	72 hours