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Incidence of Respiratory Depression in Cesarean Section

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ClinicalTrials.gov Identifier: NCT01181843
Recruitment Status : Terminated (departmental financial support withdrawn)
First Posted : August 13, 2010
Last Update Posted : November 8, 2017
Sponsor:
Collaborator:
Forsyth Medical Center
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Study Description
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Brief Summary:
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 or disease
Respiratory Depression Postoperative Pain

Study Design
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Study Type : Observational
Actual Enrollment : 100 participants
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
Study Start Date : July 2010
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Groups and Cohorts
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Group/Cohort
Cesearean sections receiving duramorph


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


Eligibility Criteria
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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
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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
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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
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Principal Investigator: Peter Pan, MD Wake Forest University Health Sciences
More Information
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Responsible Party: Wake Forest University
ClinicalTrials.gov Identifier: NCT01181843    
Other Study ID Numbers: FMC IRB 2010.200
First Posted: August 13, 2010    Key Record Dates
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:
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Respiratory Insufficiency
Pain, Postoperative
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
 Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases