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

NCT02014714 | Unknown Phase 1 DMC

• 1 other identifier: 201311-0466
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea of Adult

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Morphine

ACTIVE COMPARATOR

Intrathecal Morphine 0.1mg

Drug: Morphine

Fentanyl

ACTIVE COMPARATOR

Intrathecal Fentanyl 40mcg

Drug: Fentanyl

Interventions

Morphine DRUG

Drug: Morphine Depending on the randomization schedule, 0.1mg of morphine or will be added to the intrathecal mixture.

Morphine

Fentanyl DRUG

Drug: Fentanyl 40mcg Depending on the randomization schedule, 40μg of fentanyl will be added to the intrathecal mixture.

Also known as: Fentanyl-hameln

Fentanyl

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• ASA I - II
• Patients who admitted for orthopedic surgery and consented for regional anesthesia
• STOP - BANG score ≥ 5

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

RECRUITING

MeSH Terms

Interventions

Morphine; Fentanyl

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Wang Chew Yin

  University of Malaya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang Chew Yin

CONTACT

60379494422; wangcy1836@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2013
• First Posted: December 18, 2013
• Study Start: December 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: December 19, 2013

Record last verified: 2013-12

Locations

MY (1)