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

Phase 1

• Conditions: Obstructive Sleep Apnea of Adult
• Interventions: Drug: Morphine; Drug: Fentanyl

• Registration Number: NCT02014714
• Lead Sponsor: University of Malaya

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.

Study Timeline

• Status Verified: 2013-12
• Study Start: 2013-12
• Study First Submitted: 2013-12-12
• Study First Submitted QC: 2013-12-17
• Study First Posted: 2013-12-18
• Last Update Submitted: 2013-12-18
• Last Update Posted: 2013-12-19
• Primary Completion: 2014-06
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Morphine	Morphine	Intrathecal Morphine 0.1mg
Fentanyl	Fentanyl	Intrathecal Fentanyl 40mcg

Primary Outcome Measures

Name	Time	Method
Oxygen Desaturation Index (ODI)	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.
Respiratory Rate (RR)	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)	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.

Trial Locations

Locations (1)

University Malaya Medical Centre; 🇲🇾 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia