Impact of Tramadol and Oxycodone on Sleep Apnea

Phase 4

Completed

• Conditions: Sleep Apnea
• Interventions: Drug: Oxycodone; Drug: Tramadol

• Registration Number: NCT03454217
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-27
• Study First Submitted QC: 2018-02-27
• Study Start: 2018-03-01
• Study First Posted: 2018-03-05
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxycodone	Oxycodone	Postoperative pain treatment with oxycodone
Tramadol	Tramadol	Postoperative pain treatment with tramadol

Primary Outcome Measures

Name	Time	Method
Apnea hypopnea index while lying supine	Postoperative night 1	Apnea hypopnea index while lying supine

Secondary Outcome Measures

Name	Time	Method
Apnea hypopnea index in another position than supine	Postoperative night 3
Mean pulse oxymetry	Postoperative night 3
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

Trial Locations

Locations (1)

Lausanne University Hospital; 🇨🇭 Lausanne, Vaud, Switzerland