Incidence of Respiratory Depression in Cesarean Section

This study is currently recruiting participants.
Verified March 2013 by Wake Forest School of Medicine
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

August 12, 2010
March 5, 2013
July 2010
June 2013   (final data collection date for primary outcome measure)
RESPIRATORY DEPRESSION [ Time Frame: 24 HOURS ] [ Designated as safety issue: No ]
RESPIRATORY DEPRESSION OBSERVATION ONLY OF CURRENT PRACTICES, DOES NOT INVOLVE TREATMENT
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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
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.
 
Recruiting
100
June 2013
June 2013   (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
Female
18 Years to 55 Years
No
Contact: Lynnette Harris, RN, BSN 336-718-6049 lcharris@wakehealth.edu
United States
 
NCT01181843
FMC IRB 2010.200
Yes
Dr. Peter H. Pan, M.D., MSEE, Wake Forest University
Wake Forest School of Medicine
Forsyth Medical Center
Principal Investigator: Peter Pan, MD Wake Forest School of Medicine
Wake Forest School of Medicine
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP