Incidence of Respiratory Depression in Cesarean Section
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ClinicalTrials.gov Identifier: NCT01181843
Recruitment Status :
(departmental financial support withdrawn)
First Posted : August 13, 2010
Last Update Posted : November 8, 2017
Wake Forest University
Forsyth Medical Center
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )
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.
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
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Ages Eligible for Study:
18 Years to 55 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
subjects having an elective cesearean section and having as their anesthetic either a spinal or epidural and receiving duramorph
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
Have known contraindication/allergy to neuraxial anesthesia or morphine.