Impact of Tramadol and Oxycodone on Sleep Apnea

Sleep Apnea Clinical Trial

— TROXAT  

Official title:

Impact of Tramadol and Oxycodone on Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03454217
• Other study ID #: CER 2017-01976
• Status: Completed
• Phase: Phase 4
• Start date: March 1, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: January 2021
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

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

Locations

Country	Name	City	State
Switzerland	Lausanne University Hospital	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

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