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OpenTrials
Completed

NCT Number: NCT03454217

Impact of Tramadol and Oxycodone on Sleep Apnea

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.

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Key information

Conditions

Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Lausanne University Hospital

Lausanne, Canton of Vaud, 1011, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxycodone

Drug

Postoperative pain treatment with oxycodone

Tramadol

Drug

Postoperative pain treatment with tramadol

Primary outcomes

  1. Apnea hypopnea index while lying supine

    Time frame: Postoperative night 1

    Apnea hypopnea index while lying supine

Secondary outcomes

  1. Apnea hypopnea index in another position than supine

    Time frame: Postoperative night 1

  2. Mean pulse oxymetry

    Time frame: Postoperative night 1

  3. Apnea hypopnea index while lying supine

    Time frame: Postoperative night 3

  4. Apnea hypopnea index in another position than supine

    Time frame: Postoperative night 3

  5. Mean pulse oxymetry

    Time frame: Postoperative night 3

  6. Pains scores (numeric rating scale)

    Time frame: Postoperative day 0, 1, 2 and 3

  7. Opioid (oxycodone or tramadol) consumption

    Time frame: Postoperative day 0, 1, 2 and 3

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Acronym: TROXAT

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 5, 2018
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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