Sleep Apnea Syndromes
Conditions
Brief summary
Intrathecal morphine is commonly used as an analgesic adjunct for hip arthroplasty performed under spinal anaesthesia. Sleep apnea syndrome is a condition that affects up to 10% of the patients. Effect of intrathecal hydrophilic opioids on the frequency and duration of apneic episodes is unknown. The objective of this randomised controlled trial is to investigate the effect of intrathecal morphine and surgery on apneic episodes.
Interventions
DRUGBupivacaine with normal saline
Isobaric bupivacaine 15 mg + normal saline 0.5 cc
DRUGBupivacaine with intrathecal morphine
Isobaric bupivacaine 15 mg + intrathecal morphine 100 mcg
Sponsors
Centre Hospitalier Universitaire Vaudois
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* physical status I - III * patients scheduled to undergo hip arthroplasty
Exclusion criteria
* planned surgical duration more than 3 hours * contraindication to spinal anaesthesia * severe respiratory disease * patient known and treated for sleep apnea syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| apnea hypopnea index while lying supine | postoperative night 0 |
Secondary
| Measure | Time frame |
|---|---|
| mean pulse oxymetry | postoperative night 0 |
| STOP-BANG questionnaire | 24 h before surgery |
| Berlin questionnaire | 24 h before surgery |
| Epworth questionnaire | 24 h before surgery |
| apnea hypopnea index while lying in another position than supine | postoperative night 0 |
| oxycodone consumption (mg) | postoperative day 0, 1, 2 and 3 |
| postoperative nausea and vomiting (yes/no) | postoperative day 0, 1, 2 and 3 |
| Pruritus (yes/no) | postoperative day 0, 1, 2 and 3 |
| pain scores (numeric rating scale, 0-10) | postoperative day 0, 1, 2 and 3 |
Countries
Switzerland
Outcome results
None listed