- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02014714
Single Dose Morphine and Fentanyl Added to Intrathecal Mixture on Orthopedics Patients With Undiagnosed Obstructive Sleep Apnea
Randomized Comparison Study of Single Dose Morphine and Fentanyl Added to Intrathecal Mixture on Orthopedics Patients With Undiagnosed Obstructive Sleep Apnea
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Wang Chew Yin
- Phone Number: 2052 60379494422
- Email: wangcy1836@gmail.com
Study Locations
-
-
Wilayah Persekutuan Kuala Lumpur
-
Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia, 50603
- Recruiting
- University Malaya Medical Centre
-
Contact:
- Wang Chew Yin
- Phone Number: 2052 60374974422
- Email: wangcy1836@gmail.com
-
Sub-Investigator:
- Chong Kai Chin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Morphine
Intrathecal Morphine 0.1mg
|
Drug: Morphine Depending on the randomization schedule, 0.1mg of morphine or will be added to the intrathecal mixture.
|
Active Comparator: Fentanyl
Intrathecal Fentanyl 40mcg
|
Drug: Fentanyl 40mcg Depending on the randomization schedule, 40μg of fentanyl will be added to the intrathecal mixture.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Respiratory Rate (RR)
Time Frame: 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.
|
72 hours post operatively
|
Heart Rate (HR)
Time Frame: 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.
|
72 hours post-operative
|
Oxygen Desaturation Index (ODI)
Time Frame: 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.
|
72 hours post-operative
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wang Chew Yin, University of Malaya
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Signs and Symptoms, Respiratory
- Sleep Apnea Syndromes
- Sleep Apnea, Obstructive
- Apnea
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Fentanyl
- Morphine
Other Study ID Numbers
- 201311-0466
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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