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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Recruitment Status : Terminated (departmental financial support withdrawn)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
Forsyth Medical Center
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

August 12, 2010
August 13, 2010
November 8, 2017
July 2010
June 2014   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01181843 on ClinicalTrials.gov Archive Site
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Incidence of Respiratory Depression in Cesarean Section
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
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.
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Observational Model: Other
Time Perspective: Prospective
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Probability Sample
subjects having an elective cesearean section and having as their anesthetic either a spinal or epidural and receiving duramorph
  • Respiratory Depression
  • Postoperative Pain
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Cesearean sections receiving duramorph
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
June 2014
June 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 55 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
FMC IRB 2010.200
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Wake Forest University Health Sciences ( Wake Forest University )
Wake Forest University
Forsyth Medical Center
Principal Investigator: Peter Pan, MD Wake Forest University Health Sciences
Wake Forest University Health Sciences
February 2017