Single Dose Morphine and Fentanyl Added to Intrathecal Mi... | NCT02014714

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

NCT02014714

Sponsor

University of Malaya

Status

Unknown status

Last Update Posted

Dec 19, 2013Estimated

Enrollment

40Estimated

Phase

Phase 1

Conditions

Obstructive Sleep Apnea of Adult

Interventions

Morphine
Fentanyl

Countries

Malaysia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Jun 2014Estimated

Completion Date

Jun 2014Estimated

First Submitted Date

Dec 12, 2013

First Submission Date that Met QC Criteria

Dec 17, 2013

First Posted Date

Dec 18, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2013

Last Update Posted Date

Dec 19, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Morphine	Active Comparator	Intrathecal Morphine 0.1mg	Drug: Morphine
Fentanyl	Active Comparator	Intrathecal Fentanyl 40mcg	Drug: Fentanyl

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Morphine	Drug	Drug: Morphine Depending on the randomization schedule, 0.1mg of morphine or will be added to the intrathecal mixture.	Morphine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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.	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.	72 hours post-operative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wang Chew Yin	Contact	60379494422	2052	wangcy1836@gmail.com

Overall Officials

Name	Affiliation	Role
Wang Chew Yin	University of Malaya	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Malaya Medical Centre	Recruiting	Kuala Lumpur	Kuala Lumpur	50603	Malaysia

Intervention Browse Module

MeSH Terms

ID	Term
D009020	Morphine
D005283	Fentanyl

Ancestor Terms

ID	Term
D009022	Morphine Derivatives
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids

Browse Leaves

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Browse Branches

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