Single Dose Morphine and Fentanyl Added to Intrathecal Mixture on Orthopedics Patients With Undiagnosed Obstructive Sleep Apnea

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Comparison Study of Single Dose Morphine and Fentanyl Added to Intrathecal Mixture on Orthopedics Patients With Undiagnosed Obstructive Sleep Apnea

Conditions
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Obstructive Sleep Apnea of Adult

Intervention / Treatment
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* Drug: Morphine
* Drug: Fentanyl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 ASA I - II Patients who admitted for orthopedic surgery and consented for regional anesthesia STOP - BANG score ≥ 5 Exclusion Criteria: Refused to give informed consent Previous diagnosis and treatment of OSA or any sleep-related breathing disorder Allergic to morphine / fentanyl / Local anesthetic Contra-indicated for regional anesthesia Pregnant woman Contraindication to either of the oral analgesia as in protocol

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Morphine<br>Intrathecal Morphine 0.1mg | Drug: Morphine<br>* Drug: Morphine Depending on the randomization schedule, 0.1mg of morphine or will be added to the intrathecal mixture.<br>|
| Active Comparator: Fentanyl<br>Intrathecal Fentanyl 40mcg | Drug: Fentanyl<br>* Drug: Fentanyl 40mcg Depending on the randomization schedule, 40μg of fentanyl will be added to the intrathecal mixture.<br>* Other names: Fentanyl-hameln;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Rate (RR) | The end point of the study is to assess the respiratory rate (RR) within 72 hours post-operatively in both arms of the patients. | 72 hours post operatively | 
| Heart Rate (HR) | The end point of the study is to assess the heart rate (HR) within 72 hours post-operatively in both arms of the patients. | 72 hours post-operative | 
| Oxygen Desaturation Index (ODI) | 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. | 72 hours post-operative |