Impact of Tramadol and Oxycodone on Sleep Apnea (TROXAT)

Vaud University Hospital Center

Status and phase: Completed; Phase 4

Conditions: Sleep Apnea

Treatments: Drug: Oxycodone; Drug: Tramadol

Study type: Interventional

Funder types: Other

Identifiers

NCT03454217

CER 2017-01976

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Oxycodone

Active Comparator group

Description:

Postoperative pain treatment with oxycodone

Treatment:

Drug: Oxycodone

Tramadol

Active Comparator group

Description:

Postoperative pain treatment with tramadol

Treatment:

Drug: Tramadol