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

Obstructive Sleep Apnea of Adult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02014714
• Other study ID #: 201311-0466
• Status: Recruiting
• Phase: Phase 1
• First received: December 12, 2013
• Last updated: December 18, 2013
• Start date: December 2013
• Est. completion date: June 2014

Study information

• Verified date: December 2013
• Source: University of Malaya
• Contact: Wang Chew Yin
• Phone: 60379494422
• Email: wangcy1836[@]gmail.com
• Is FDA regulated: No
• Health authority: Malaysia: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea of Adult
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• Morphine
Drug: Morphine Depending on the randomization schedule, 0.1mg of morphine or will be added to the intrathecal mixture.
• Fentanyl
Drug: Fentanyl 40mcg Depending on the randomization schedule, 40µg of fentanyl will be added to the intrathecal mixture.

Locations

Country	Name	City	State
Malaysia	University Malaya Medical Centre	Kuala Lumpur	Wilayah Persekutuan Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes