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Incidence of Respiratory Depression in Cesarean Section

This study is currently recruiting participants.
Verified March 2013 by Wake Forest University
Sponsor:
Collaborator:
Forsyth Medical Center
Information provided by (Responsible Party):
Dr. Peter H. Pan, M.D., MSEE, Wake Forest University
ClinicalTrials.gov Identifier:
NCT01181843
First received: August 12, 2010
Last updated: March 5, 2013
Last verified: March 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Wake Forest University:

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 2013
Estimated Primary Completion Date: June 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01181843

Contacts
Contact: Lynnette Harris, RN, BSN 336-718-6049 lcharris@wakehealth.edu

Locations
United States, North Carolina
Forsyth Medical Center-Dept of OB Anesthesia Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Lynnette Harris, RN, BSN     336-718-6049     lcharris@wakehealth.edu    
Principal Investigator: Peter H. Pan, MD            
Sponsors and Collaborators
Wake Forest University
Forsyth Medical Center
Investigators
Principal Investigator: Peter Pan, MD Wake Forest University
  More Information

No publications provided

Responsible Party: Dr. Peter H. Pan, M.D., MSEE, Anesthesiologist, Wake Forest University
ClinicalTrials.gov Identifier: NCT01181843     History of Changes
Other Study ID Numbers: FMC IRB 2010.200
Study First Received: August 12, 2010
Last Updated: March 5, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by 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
 Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013