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

NCT02014714 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2013-12-19

No results posted yet for this study

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.

Conditions

  • Obstructive Sleep Apnea of Adult

Interventions

DRUG

Morphine

Drug: Morphine Depending on the randomization schedule, 0.1mg of morphine or will be added to the intrathecal mixture.

DRUG

Fentanyl

Drug: Fentanyl 40mcg Depending on the randomization schedule, 40μg of fentanyl will be added to the intrathecal mixture.

Sponsors & Collaborators

  • University of Malaya

    lead OTHER

Principal Investigators

  • Wang Chew Yin · University of Malaya

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • Malaysia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02014714 on ClinicalTrials.gov