Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of Intrathecal Morphine on Sleep Apnea Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02566226
Recruitment Status : Completed
First Posted : October 2, 2015
Last Update Posted : November 4, 2019
Sponsor:
Information provided by (Responsible Party):
Eric Albrecht, Centre Hospitalier Universitaire Vaudois

Brief Summary:
Intrathecal morphine is commonly used as an analgesic adjunct for hip arthroplasty performed under spinal anaesthesia. Sleep apnea syndrome is a condition that affects up to 10% of the patients. Effect of intrathecal hydrophilic opioids on the frequency and duration of apneic episodes is unknown. The objective of this randomised controlled trial is to investigate the effect of intrathecal morphine and surgery on apneic episodes.

Condition or disease Intervention/treatment Phase
Sleep Apnea Syndromes Drug: Bupivacaine with normal saline Drug: Bupivacaine with intrathecal morphine Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Impact of Intrathecal Morphine on Sleep Apnea Syndrome After Hip Arthroplasty Performed Under Spinal Anaesthesia
Study Start Date : November 2015
Actual Primary Completion Date : March 2019
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Placebo Comparator: Bupivacaine with normal saline Drug: Bupivacaine with normal saline
Isobaric bupivacaine 15 mg + normal saline 0.5 cc

Active Comparator: Bupivacaine with intrathecal morphine Drug: Bupivacaine with intrathecal morphine
Isobaric bupivacaine 15 mg + intrathecal morphine 100 mcg




Primary Outcome Measures :
  1. apnea hypopnea index while lying supine [ Time Frame: postoperative night 0 ]

Secondary Outcome Measures :
  1. apnea hypopnea index while lying in another position than supine [ Time Frame: postoperative night 0 ]
  2. mean pulse oxymetry [ Time Frame: postoperative night 0 ]
  3. STOP-BANG questionnaire [ Time Frame: 24 h before surgery ]
  4. Berlin questionnaire [ Time Frame: 24 h before surgery ]
  5. Epworth questionnaire [ Time Frame: 24 h before surgery ]
  6. pain scores (numeric rating scale, 0-10) [ Time Frame: postoperative day 0, 1, 2 and 3 ]
  7. oxycodone consumption (mg) [ Time Frame: postoperative day 0, 1, 2 and 3 ]
  8. postoperative nausea and vomiting (yes/no) [ Time Frame: postoperative day 0, 1, 2 and 3 ]
  9. Pruritus (yes/no) [ Time Frame: postoperative day 0, 1, 2 and 3 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • physical status I - III
  • patients scheduled to undergo hip arthroplasty

Exclusion Criteria:

  • planned surgical duration more than 3 hours
  • contraindication to spinal anaesthesia
  • severe respiratory disease
  • patient known and treated for sleep apnea syndrome

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02566226


Locations
Layout table for location information
Switzerland
Lausanne University Hospital
Lausanne, Switzerland
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Investigators
Layout table for investigator information
Principal Investigator: Eric Albrecht, MD Lausanne University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Eric Albrecht, Program Director, Regional Anaesthesia, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT02566226    
Other Study ID Numbers: CER 265/15
First Posted: October 2, 2015    Key Record Dates
Last Update Posted: November 4, 2019
Last Verified: November 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Apnea
Sleep Apnea Syndromes
Syndrome
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Morphine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics