Impact of Tramadol and Oxycodone on Sleep Apnea (TROXAT)
Primary Purpose
Sleep Apnea
Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Oxycodone
Tramadol
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea
Eligibility Criteria
Inclusion Criteria:
- patients scheduled for orthopaedic surgery on the lower limb under a spinal anaesthesia
- physical status I-III
Exclusion Criteria:
- planned surgical duration more than 3 hours
- contraindication to spinal anaesthesia
- severe respiratory disease
- patient treated for sleep apnea syndrome
- allergy to tramadol or oxycodone
Sites / Locations
- Lausanne University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Oxycodone
Tramadol
Arm Description
Postoperative pain treatment with oxycodone
Postoperative pain treatment with tramadol
Outcomes
Primary Outcome Measures
Apnea hypopnea index while lying supine
Apnea hypopnea index while lying supine
Secondary Outcome Measures
Apnea hypopnea index in another position than supine
Mean pulse oxymetry
Apnea hypopnea index while lying supine
Apnea hypopnea index in another position than supine
Mean pulse oxymetry
Pains scores (numeric rating scale)
Opioid (oxycodone or tramadol) consumption
Full Information
NCT ID
NCT03454217
First Posted
February 27, 2018
Last Updated
January 26, 2021
Sponsor
Centre Hospitalier Universitaire Vaudois
1. Study Identification
Unique Protocol Identification Number
NCT03454217
Brief Title
Impact of Tramadol and Oxycodone on Sleep Apnea
Acronym
TROXAT
Official Title
Impact of Tramadol and Oxycodone on Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Vaudois
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Postoperative pain is usually treated with opioids. Among them, oxycodone is popular in the daily practice as it is administered orally and is easily titrated. However, side-effects include increase duration and frequency of apneic episodes. Some authors believe that tramadol has less impact on these apneic episodes during the first postoperative night, based on a trial that reported conclusive results only during the first 2 postoperative hours. The objective of this randomized controlled trial is to compare the effect of postoperative pain treatment of oxycodone with tramadol on apneic episodes during the first and third postoperative nights.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxycodone
Arm Type
Active Comparator
Arm Description
Postoperative pain treatment with oxycodone
Arm Title
Tramadol
Arm Type
Active Comparator
Arm Description
Postoperative pain treatment with tramadol
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Intervention Description
Postoperative pain treatment with oxycodone
Intervention Type
Drug
Intervention Name(s)
Tramadol
Intervention Description
Postoperative pain treatment with tramadol
Primary Outcome Measure Information:
Title
Apnea hypopnea index while lying supine
Description
Apnea hypopnea index while lying supine
Time Frame
Postoperative night 1
Secondary Outcome Measure Information:
Title
Apnea hypopnea index in another position than supine
Time Frame
Postoperative night 1
Title
Mean pulse oxymetry
Time Frame
Postoperative night 1
Title
Apnea hypopnea index while lying supine
Time Frame
Postoperative night 3
Title
Apnea hypopnea index in another position than supine
Time Frame
Postoperative night 3
Title
Mean pulse oxymetry
Time Frame
Postoperative night 3
Title
Pains scores (numeric rating scale)
Time Frame
Postoperative day 0, 1, 2 and 3
Title
Opioid (oxycodone or tramadol) consumption
Time Frame
Postoperative day 0, 1, 2 and 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients scheduled for orthopaedic surgery on the lower limb under a spinal anaesthesia
physical status I-III
Exclusion Criteria:
planned surgical duration more than 3 hours
contraindication to spinal anaesthesia
severe respiratory disease
patient treated for sleep apnea syndrome
allergy to tramadol or oxycodone
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Albrecht
Organizational Affiliation
Lausanne University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lausanne University Hospital
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD will be shared upon request
Citations:
PubMed Identifier
35241942
Citation
Albrecht E, Pereira P, Bayon V, Berger M, Wegrzyn J, Antoniadis A, Heinzer R. The Relationship Between Postoperative Opioid Analgesia and Sleep Apnea Severity in Patients Undergoing Hip Arthroplasty: A Randomized, Controlled, Triple-Blinded Trial. Nat Sci Sleep. 2022 Feb 25;14:303-310. doi: 10.2147/NSS.S348834. eCollection 2022.
Results Reference
derived
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Impact of Tramadol and Oxycodone on Sleep Apnea
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