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Incidence of Respiratory Depression in Cesarean Section

Sponsor
Wake Forest University (Other)
Overall Status
Terminated
CT.gov ID
NCT01181843
Collaborator
Forsyth Medical Center (Other)
100
Enrollment
1
Location
47
Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    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 :
    Jul 1, 2010
    Actual Primary Completion Date :
    Jun 1, 2014
    Actual Study Completion Date :
    Jun 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    Cesearean sections receiving duramorph

    Outcome Measures

    Primary Outcome Measures

    1. RESPIRATORY DEPRESSION [24 HOURS]

      RESPIRATORY DEPRESSION OBSERVATION ONLY OF CURRENT PRACTICES, DOES NOT INVOLVE TREATMENT

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wake Forest University
    ClinicalTrials.gov Identifier:
    NCT01181843
    Other Study ID Numbers:
    • FMC IRB 2010.200
    First Posted:
    Aug 13, 2010
    Last Update Posted:
    Nov 8, 2017
    Last Verified:
    Feb 1, 2017
    Keywords provided by Wake Forest University
    postoperative pain management
    respiratory depression
    capnography
    duramorph
    Additional relevant MeSH terms:
    Respiratory Insufficiency
    Pain, Postoperative
    Depression
    Depressive Disorder

    Study Results

    No Results Posted as of Nov 8, 2017