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

NCT ID: NCT02014714

Last Updated: 2013-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-06-30

Brief Summary

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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

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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

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Obstructive Sleep Apnea of Adult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Morphine

Intrathecal Morphine 0.1mg

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

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

Fentanyl

Intrathecal Fentanyl 40mcg

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

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

Interventions

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Morphine

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

Intervention Type DRUG

Fentanyl

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

Intervention Type DRUG

Other Intervention Names

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Fentanyl-hameln

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Malaya

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wang Chew Yin

Role: PRINCIPAL_INVESTIGATOR

University of Malaya

Locations

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University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, Malaysia

Site Status RECRUITING

Countries

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Malaysia

Central Contacts

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Wang Chew Yin

Role: CONTACT

Phone: 60379494422

Email: [email protected]

Facility Contacts

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Wang Chew Yin

Role: primary

Other Identifiers

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201311-0466

Identifier Type: -

Identifier Source: org_study_id