Impact of Tramadol and Oxycodone on Sleep Apnea

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 30, 2020

Interventions

  • Drug: Oxycodone
    • Postoperative pain treatment with oxycodone
  • Drug: Tramadol
    • Postoperative pain treatment with tramadol

Arms, Groups and Cohorts

  • Active Comparator: Oxycodone
    • Postoperative pain treatment with oxycodone
  • Active Comparator: Tramadol
    • Postoperative pain treatment with tramadol

Clinical Trial Outcome Measures

Primary Measures

  • Apnea hypopnea index while lying supine
    • Time Frame: Postoperative night 1
    • Apnea hypopnea index while lying supine

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire Vaudois
  • Provider of Information About this Clinical Study
    • Principal Investigator: Eric Albrecht, Program director of regional anaesthesia – Centre Hospitalier Universitaire Vaudois
  • Overall Official(s)
    • Eric Albrecht, Principal Investigator, Lausanne University Hospital

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