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

Phase 1UnknownNCT02014714

University of Malaya40 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Obstructive Sleep Apnea of Adult

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.