Incidence of Respiratory Depression in Cesarean Section

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

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.

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 ]

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)
Cesearean sections receiving duramorph


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


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 identifier: NCT01181843

Contact: Lynnette Harris, RN, BSN 336-718-6049

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   
Principal Investigator: Peter H. Pan, MD         
Sponsors and Collaborators
Wake Forest School of Medicine
Forsyth Medical Center
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 University 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 School of Medicine:
postoperative pain management
respiratory depression

Additional relevant MeSH terms:
Depressive Disorder
Pain, Postoperative
Respiratory Insufficiency
Behavioral Symptoms
Mood Disorders
Mental Disorders
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases processed this record on April 17, 2014