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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
Centre Hospitalier Universitaire Vaudois
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 27, 2018
Last Updated
January 26, 2021
Sponsor
Centre Hospitalier Universitaire Vaudois
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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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