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

Primary Purpose

Obstructive Sleep Apnea of Adult

Status
Unknown status
Phase
Phase 1
Locations
Malaysia
Study Type
Interventional
Intervention
Morphine
Fentanyl
Sponsored by
University of Malaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea of Adult

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Malaya Medical CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Morphine

Fentanyl

Arm Description

Intrathecal Morphine 0.1mg

Intrathecal Fentanyl 40mcg

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 12, 2013
Last Updated
December 18, 2013
Sponsor
University of Malaya
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1. Study Identification

Unique Protocol Identification Number
NCT02014714
Brief Title
Single Dose Morphine and Fentanyl Added to Intrathecal Mixture on Orthopedics Patients With Undiagnosed Obstructive Sleep Apnea
Official Title
Randomized Comparison Study of Single Dose Morphine and Fentanyl Added to Intrathecal Mixture on Orthopedics Patients With Undiagnosed Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Malaya

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea of Adult

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Morphine
Arm Type
Active Comparator
Arm Description
Intrathecal Morphine 0.1mg
Arm Title
Fentanyl
Arm Type
Active Comparator
Arm Description
Intrathecal Fentanyl 40mcg
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
Drug: Morphine Depending on the randomization schedule, 0.1mg of morphine or will be added to the intrathecal mixture.
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Other Intervention Name(s)
Fentanyl-hameln
Intervention Description
Drug: Fentanyl 40mcg Depending on the randomization schedule, 40μg of fentanyl will be added to the intrathecal mixture.
Primary Outcome Measure Information:
Title
Respiratory Rate (RR)
Description
The end point of the study is to assess the respiratory rate (RR) within 72 hours post-operatively in both arms of the patients.
Time Frame
72 hours post operatively
Title
Heart Rate (HR)
Description
The end point of the study is to assess the heart rate (HR) within 72 hours post-operatively in both arms of the patients.
Time Frame
72 hours post-operative
Title
Oxygen Desaturation Index (ODI)
Description
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.
Time Frame
72 hours post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wang Chew Yin
Phone
60379494422
Ext
2052
Email
wangcy1836@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wang Chew Yin
Organizational Affiliation
University of Malaya
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
State/Province
Wilayah Persekutuan Kuala Lumpur
ZIP/Postal Code
50603
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Chew Yin
Phone
60374974422
Ext
2052
Email
wangcy1836@gmail.com
First Name & Middle Initial & Last Name & Degree
Chong Kai Chin

12. IPD Sharing Statement

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

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