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Impact of Tramadol and Oxycodone on Sleep Apnea (TROXAT)

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ClinicalTrials.gov Identifier: NCT03454217
Recruitment Status : Recruiting
First Posted : March 5, 2018
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
Eric Albrecht, Centre Hospitalier Universitaire Vaudois

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.

Condition or disease Intervention/treatment Phase
Sleep Apnea Drug: Oxycodone Drug: Tramadol Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Tramadol and Oxycodone on Sleep Apnea
Actual Study Start Date : February 27, 2018
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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




Primary Outcome Measures :
  1. Apnea hypopnea index while lying supine [ Time Frame: Postoperative night 1 ]
    Apnea hypopnea index while lying supine


Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03454217


Contacts
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Contact: Eric Albrecht, PD-MER +41 79 556 63 41 eric.albrecht@chuv.ch

Locations
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Switzerland
Lausanne University Hospital Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Eric Albrecht, PD-MER    +41 79 556 63 41    eric.albrecht@chuv.ch   
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Investigators
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Principal Investigator: Eric Albrecht Lausanne University Hospital

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Responsible Party: Eric Albrecht, Program director of regional anaesthesia, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT03454217     History of Changes
Other Study ID Numbers: CER 2017-01976
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be shared upon request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Tramadol
Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents