Impact of Tramadol and Oxycodone on Sleep Apnea

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03454217

Acronym

TROXAT

Enrollment

Registered

2018-03-05

Start date

2018-03-01

Completion date

2020-09-30

Last updated

2021-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea

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.

Interventions

DRUGOxycodone

Postoperative pain treatment with oxycodone

DRUGTramadol

Postoperative pain treatment with tramadol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Apnea hypopnea index while lying supine	Postoperative night 1	Apnea hypopnea index while lying supine

Secondary

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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026