drugset / Trial / NCT02014714

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

NCT02014714

Phase 1 Unknown 40 enrolled University of Malaya
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2013-12
Primary completion
2014-06
Completion
2014-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fentanyl Other / unclassified 40 ug Intrathecal
Comparator Morphine Other / unclassified 0.1 mg Intrathecal