Impact of Tramadol and Oxycodone on Sleep Apnea (TROXAT)

January 26, 2021 updated by: Eric Albrecht, Centre Hospitalier Universitaire Vaudois
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • Lausanne University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Oxycodone
Postoperative pain treatment with oxycodone
Drug: Oxycodone
Postoperative pain treatment with oxycodone
Active Comparator: Tramadol
Postoperative pain treatment with tramadol
Drug: Tramadol
Postoperative pain treatment with tramadol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apnea hypopnea index while lying supine
Time Frame: Postoperative night 1
Apnea hypopnea index while lying supine
Postoperative night 1

Secondary Outcome Measures

Outcome Measure
Time Frame
Apnea hypopnea index in another position than supine
Time Frame: Postoperative night 1
Postoperative night 1
Mean pulse oxymetry
Time Frame: Postoperative night 1
Postoperative night 1
Apnea hypopnea index while lying supine
Time Frame: Postoperative night 3
Postoperative night 3
Apnea hypopnea index in another position than supine
Time Frame: Postoperative night 3
Postoperative night 3
Mean pulse oxymetry
Time Frame: Postoperative night 3
Postoperative night 3
Pains scores (numeric rating scale)
Time Frame: Postoperative day 0, 1, 2 and 3
Postoperative day 0, 1, 2 and 3
Opioid (oxycodone or tramadol) consumption
Time Frame: Postoperative day 0, 1, 2 and 3
Postoperative day 0, 1, 2 and 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Vaudois

Investigators

  • Principal Investigator: Eric Albrecht, Lausanne University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

February 27, 2018

First Submitted That Met QC Criteria

February 27, 2018

First Posted (Actual)

March 5, 2018

Study Record Updates

Last Update Posted (Actual)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CER 2017-01976

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

IPD will be shared upon request

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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