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Incidence of Respiratory Depression in Cesarean Section

This study has been terminated.
(departmental financial support withdrawn)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01181843
First Posted: August 13, 2010
Last Update Posted: November 8, 2017
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.
Collaborator:
Forsyth Medical Center
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )
  Purpose
This study is designed to determine the incidence and severity of respiratory depression in elective cesarean section patients who have received a spinal or epidural narcotic called duramorph for management of postoperative pain. A monitoring device called a capnograph as well as a device called a pulse oximeter is placed on the patient once in the recovery room after delivery. The capnograph monitors the carbon dioxide level that the patient breathes out as well as their respiratory rate. The pulse oximeter is a device that is taped on the patient's finger and measures their oxygen saturation level. The monitoring is maintained for 18-24 hours after surgery.

Condition
Respiratory Depression Postoperative Pain

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: A Prospective, Observational, Double-blind (Black-Box) Study Evaluating Incidence, Severity and Predictive Factors of Respiratory Depression During Postoperative Neuraxial Opioid Analgesia in Obstetric Patients After Cesarean Delivery Using Current Standard Intermittent Postoperative Monitoring Compared to Continuous Pulse Oximetry / Capnography

Resource links provided by NLM:


Further study details as provided by Wake Forest University Health Sciences ( Wake Forest University ):

Primary Outcome Measures:
  • RESPIRATORY DEPRESSION [ Time Frame: 24 HOURS ]
    RESPIRATORY DEPRESSION OBSERVATION ONLY OF CURRENT PRACTICES, DOES NOT INVOLVE TREATMENT


Enrollment: 100
Study Start Date: July 2010
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cesearean sections receiving duramorph

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
subjects having an elective cesearean section and having as their anesthetic either a spinal or epidural and receiving duramorph
Criteria

Inclusion Criteria:

  • Are female >= 18 years of age and <=55 years of age with ASA class I-III
  • Schedule for cesarean surgery
  • Are willing and able to sign informed consent form for this study
  • Are willing and able to follow the instruction in this study protocol

Exclusion Criteria:

  • Have known contraindication/allergy to neuraxial anesthesia or morphine.
  • Have an ASA class > III
  • Age > 55 years
  Contacts and Locations
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): NCT01181843


Locations
United States, North Carolina
Forsyth Medical Center-Dept of OB Anesthesia
Winston-Salem, North Carolina, United States, 27103
Sponsors and Collaborators
Wake Forest University
Forsyth Medical Center
Investigators
Principal Investigator: Peter Pan, MD Wake Forest University Health Sciences
  More Information

Responsible Party: Wake Forest University
ClinicalTrials.gov Identifier: NCT01181843     History of Changes
Other Study ID Numbers: FMC IRB 2010.200
First Submitted: August 12, 2010
First Posted: August 13, 2010
Last Update Posted: November 8, 2017
Last Verified: February 2017

Keywords provided by Wake Forest University Health Sciences ( Wake Forest University ):
postoperative pain management
respiratory depression
capnography
duramorph

Additional relevant MeSH terms:
Depression
Depressive Disorder
Pain, Postoperative
Respiratory Insufficiency
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases