Obstructive Sleep Apnea of Adult
Conditions
Brief summary
Obstructive Sleep Apnea (OSA) is a common clinical problem with a reported prevalence of 2% to 4% in the general population. The incidence was double on patients who had a diagnosis of OSA going for orthopedics surgery. Little literature composed mostly of case reports or small retrospective case-control studies exist examining the use of intrathecal opioids on outcomes in OSA patients is inconclusive. The primary objective of this study is to compare the post operative respiratory effect after single dose intrathecal morphine and intrathecal fentanyl on orthopedics patients who suspected or undiagnosed obstructive sleep apnea. Hypotheses Undiagnosed OSA patients who received intrathecal morphine are more likely to have respiratory events post-operatively.
Detailed description
This is a prospective, randomized study to compare the post operative respiratory effect after single dose intrathecal morphine (0.1mg) and intrathecal fentanyl (40mcg) on orthopedics patients who suspected or undiagnosed obstructive sleep apnea.
Interventions
DRUGMorphine
Drug: Morphine Depending on the randomization schedule, 0.1mg of morphine or will be added to the intrathecal mixture.
DRUGFentanyl
Drug: Fentanyl 40mcg Depending on the randomization schedule, 40μg of fentanyl will be added to the intrathecal mixture.
Sponsors
University of Malaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 2. ASA I - II 3. Patients who admitted for orthopedic surgery and consented for regional anesthesia 4. STOP - BANG score ≥ 5
Exclusion criteria
1. Refused to give informed consent 2. Previous diagnosis and treatment of OSA or any sleep-related breathing disorder 3. Allergic to morphine / fentanyl / Local anesthetic 4. Contra-indicated for regional anesthesia 5. Pregnant woman 6. Contraindication to either of the oral analgesia as in protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Rate (RR) | 72 hours post operatively | The end point of the study is to assess the respiratory rate (RR) within 72 hours post-operatively in both arms of the patients. |
| Heart Rate (HR) | 72 hours post-operative | The end point of the study is to assess the heart rate (HR) within 72 hours post-operatively in both arms of the patients. |
| Oxygen Desaturation Index (ODI) | 72 hours post-operative | The end point of the study is to assess the Oxygen Desaturation Index (ODI) within 72 hours post-operatively in both arms of the patients. |
Countries
Malaysia
Contacts
Primary ContactWang Chew Yin
Outcome results
None listed