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Incidence of Respiratory Depression in Cesarean Section

This study has been terminated.
(departmental financial support withdrawn)
Sponsor:
Collaborator:
Forsyth Medical Center
Information provided by (Responsible Party):
Dr. Peter H. Pan, M.D., MSEE, Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT01181843
First received: August 12, 2010
Last updated: June 4, 2014
Last verified: June 2014
  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: 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 School of Medicine:

Primary Outcome Measures:
  • RESPIRATORY DEPRESSION [ Time Frame: 24 HOURS ] [ Designated as safety issue: No ]
    RESPIRATORY DEPRESSION OBSERVATION ONLY OF CURRENT PRACTICES, DOES NOT INVOLVE TREATMENT


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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 School of Medicine
Forsyth Medical Center
Investigators
Principal Investigator: Peter Pan, MD Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Dr. Peter H. Pan, M.D., MSEE, Anesthesiologist, Wake Forest School of Medicine
ClinicalTrials.gov Identifier: NCT01181843     History of Changes
Other Study ID Numbers: FMC IRB 2010.200
Study First Received: August 12, 2010
Last Updated: June 4, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
postoperative pain management
respiratory depression
capnography
duramorph

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

ClinicalTrials.gov processed this record on November 20, 2014