TROXAT: Impact of Tramadol and Oxycodone on Sleep Apnea

• Sponsor: Centre Hospitalier Universitaire Vaudois (Other)
• Overall Status: Completed
• CT.gov ID: NCT03454217
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 31
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Actual 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: Mar 1, 2018
• Actual Primary Completion Date: Sep 30, 2020
• Actual Study Completion Date: Sep 30, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Apnea hypopnea index while lying supine [Postoperative night 1]

   Apnea hypopnea index while lying supine

Secondary Outcome Measures

1. Apnea hypopnea index in another position than supine [Postoperative night 1]

2. Mean pulse oxymetry [Postoperative night 1]

3. Apnea hypopnea index while lying supine [Postoperative night 3]

4. Apnea hypopnea index in another position than supine [Postoperative night 3]

5. Mean pulse oxymetry [Postoperative night 3]

6. Pains scores (numeric rating scale) [Postoperative day 0, 1, 2 and 3]

7. Opioid (oxycodone or tramadol) consumption [Postoperative day 0, 1, 2 and 3]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lausanne University Hospital	Lausanne	Vaud	Switzerland	1011

Sponsors and Collaborators

• Centre Hospitalier Universitaire Vaudois

Investigators

• Principal Investigator: Eric Albrecht, Lausanne University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eric Albrecht, Program director of regional anaesthesia, Centre Hospitalier Universitaire Vaudois
• ClinicalTrials.gov Identifier: NCT03454217
• Other Study ID Numbers: CER 2017-01976
• First Posted: Mar 5, 2018
• Last Update Posted: Jan 27, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Apnea; Sleep Apnea Syndromes; Oxycodone; Tramadol

Study Results

No Results Posted as of Jan 27, 2021