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(departmental financial support withdrawn)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
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Condition or disease |
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Respiratory Depression Postoperative Pain |
Study Type : | Observational |
Actual Enrollment : | 100 participants |
Observational Model: | Other |
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 |
Study Start Date : | July 2010 |
Actual Primary Completion Date : | June 2014 |
Actual Study Completion Date : | June 2014 |

Group/Cohort |
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Cesearean sections receiving duramorph |
- RESPIRATORY DEPRESSION [ Time Frame: 24 HOURS ]RESPIRATORY DEPRESSION OBSERVATION ONLY OF CURRENT PRACTICES, DOES NOT INVOLVE TREATMENT

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01181843
United States, North Carolina | |
Forsyth Medical Center-Dept of OB Anesthesia | |
Winston-Salem, North Carolina, United States, 27103 |
Principal Investigator: | Peter Pan, MD | Wake Forest University Health Sciences |
Responsible Party: | Wake Forest University |
ClinicalTrials.gov Identifier: | NCT01181843 |
Other Study ID Numbers: |
FMC IRB 2010.200 |
First Posted: | August 13, 2010 Key Record Dates |
Last Update Posted: | November 8, 2017 |
Last Verified: | February 2017 |
postoperative pain management respiratory depression capnography duramorph |
Respiratory Insufficiency Pain, Postoperative Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |
Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Respiration Disorders Respiratory Tract Diseases |