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.

Study Overview

• Status: Terminated
• Conditions: Postoperative Pain; Respiratory Depression

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Forsyth Medical Center-Dept of OB Anesthesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

subjects having an elective cesearean section and having as their anesthetic either a spinal or epidural and receiving duramorph

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cesearean sections receiving duramorph

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RESPIRATORY DEPRESSION	RESPIRATORY DEPRESSION OBSERVATION ONLY OF CURRENT PRACTICES, DOES NOT INVOLVE TREATMENT	24 HOURS

Collaborators and Investigators

• Sponsor: Wake Forest University
• Collaborators: Forsyth Medical Center
• Investigators: Principal Investigator: Peter Pan, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: August 12, 2010
• First Submitted That Met QC Criteria: August 12, 2010
• First Posted (Estimate): August 13, 2010

Study Record Updates

• Last Update Posted (Actual): November 8, 2017
• Last Update Submitted That Met QC Criteria: November 6, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: capnography; respiratory depression; postoperative pain management; duramorph
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Respiratory Tract Diseases; Mood Disorders; Respiration Disorders; Postoperative Complications; Pain; Neurologic Manifestations; Depression; Depressive Disorder; Pain, Postoperative; Respiratory Insufficiency
• Other Study ID Numbers: FMC IRB 2010.200