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

University of Malaya

Status and phase: Unknown; Phase 1

Conditions: Obstructive Sleep Apnea of Adult

Treatments: Drug: Morphine; Drug: Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT02014714

201311-0466

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Morphine

Active Comparator group

Description:

Intrathecal Morphine 0.1mg

Treatment:

Drug: Morphine

Fentanyl

Active Comparator group

Description:

Intrathecal Fentanyl 40mcg

Treatment:

Drug: Fentanyl