This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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(departmental financial support withdrawn)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 University Health Sciences
ClinicalTrials.gov Identifier:
NCT01181843
First received: August 12, 2010
Last updated: February 7, 2017
Last verified: February 2017
August 12, 2010
February 7, 2017
July 2010
June 2014   (Final data collection date for primary outcome measure)
RESPIRATORY DEPRESSION [ Time Frame: 24 HOURS ]
RESPIRATORY DEPRESSION OBSERVATION ONLY OF CURRENT PRACTICES, DOES NOT INVOLVE TREATMENT
Not Provided
Complete list of historical versions of study NCT01181843 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.
Not Provided
Observational
Observational Model: Other
Time Perspective: Prospective
Not Provided
Not Provided
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
Not Provided
Cesearean sections receiving duramorph
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
100
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)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01181843
FMC IRB 2010.200
Yes
Not Provided
Not Provided
Dr. Peter H. Pan, M.D., MSEE, Wake Forest University Health Sciences
Wake Forest University
Forsyth Medical Center
Principal Investigator: Peter Pan, MD Wake Forest University Health Sciences
Wake Forest University Health Sciences
February 2017

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