Obstructive Sleep Apnea of AdultPhase 1NCT02014714
Single Dose Morphine and Fentanyl Added to Intrathecal Mixture on Orthopedics Patients With Undiagnosed Obstructive Sleep Apnea
A Phase 1 study testing Morphine and Fentanyl in people with Obstructive Sleep Apnea of Adult, run by University of Malaya at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea of Adult
- What is being tested?
- Morphine and Fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteMalaysia
- Study dates
- Dec 2013to Jun 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- ASA I - II
- Patients who admitted for orthopedic surgery and consented for regional anesthesia
- STOP - BANG score ≥ 5
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 50603
Wang Chew Yin, 60374974422 ext. 2052, wangcy1836@gmail.com
Chong Kai Chin
About this study
Official title: 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.
Read more
Hypotheses
Undiagnosed OSA patients who received intrathecal morphine are more likely to have respiratory events post-operatively.
Read the 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.
- Conditions
- Obstructive Sleep Apnea of Adult
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
Drug: Morphine Depending on the randomization schedule, 0.1mg of morphine or will be added to the intrathecal mixture.
FentanylDrug
Also called Fentanyl-hameln
Drug: Fentanyl 40mcg Depending on the randomization schedule, 40μg of fentanyl will be added to the intrathecal mixture.
| Study group | Role | What they receive |
|---|---|---|
| Morphine | Active comparator | Intrathecal Morphine 0.1mg Receives: Drug: Morphine |
| Fentanyl | Active comparator | Intrathecal Fentanyl 40mcg Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 72 hours post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea of AdultStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wang Chew Yin, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02014714
- Sponsor's protocol ID
- 201311-0466
- Status last verified
- Dec 2013
- First submitted
- 12 Dec 2013
- Last updated
- 19 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison Study of Single Dose Morphine and Fentanyl Added to Intrathecal Mixture on Orthopedics Patients With Undiagnosed Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT02014714
- Acronym / sponsor ID
- 201311-0466
- Conditions
- Obstructive Sleep Apnea of Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 18 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morphine | Active comparator | Drug: MorphineIntrathecal Morphine 0.1mg |
| Fentanyl | Active comparator | Drug: FentanylIntrathecal Fentanyl 40mcg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18
- ASA I - II
- Patients who admitted for orthopedic surgery and consented for regional anesthesia
- STOP - BANG score ≥ 5
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MorphineDrug: Morphine Depending on the randomization schedule, 0.1mg of morphine or will be added to the intrathecal mixture. | Drug | Morphine |
| FentanylAlso: Fentanyl-hamelnDrug: Fentanyl 40mcg Depending on the randomization schedule, 40μg of fentanyl will be added to the intrathecal mixture. | Drug | Fentanyl |
Primary outcome
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wang Chew Yin principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Morphine and Fentanyl in people with Obstructive Sleep Apnea of Adult, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wang Chew Yin (60379494422 ext. 2052, wangcy1836@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Rate (RR) (time frame: 72 hours post operatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2013; AzTrials last refreshed its copy on 6 Nov 2026.