Single Dose Morphine and Fentanyl Added to Intrathecal Mixture on Orthopedics Patients With Undiagnosed Obstructive Sleep Apnea
Information source: University of Malaya
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obstructive Sleep Apnea of Adult
Intervention: Morphine (Drug); Fentanyl (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: University of Malaya Official(s) and/or principal investigator(s):
Wang Chew Yin, Principal Investigator, Affiliation: University Malaya Medical Centre
Overall contact:
Wang Chew Yin, Phone: 60379494422, Ext: 2052, Email: wangcy1836@gmail.com
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.
Clinical Details
Official title: Randomized Comparison Study of Single Dose Morphine and Fentanyl Added to Intrathecal Mixture on Orthopedics Patients With Undiagnosed Obstructive Sleep Apnea
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Respiratory Rate (RR)Heart Rate (HR) Oxygen Desaturation Index (ODI)
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Wang Chew Yin, Phone: 60379494422, Ext: 2052, Email: wangcy1836@gmail.com
University Malaya Medical Centre, Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur 50603, Malaysia; Recruiting
Wang Chew Yin, Phone: 60374974422, Ext: 2052, Email: wangcy1836@gmail.com
Chong Kai Chin, Sub-Investigator
Additional Information
Starting date: December 2013
Last updated: December 18, 2013
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