Incidence of Respiratory Depression in Cesarean Section

NCT01181843 | Terminated DMC

• 1 other identifier: FMC IRB 2010.200
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiratory Depression; Postoperative Pain

Keywords

postoperative pain management; respiratory depression; capnography; duramorph

Outcome Measures

Primary Outcomes (1)

• RESPIRATORY DEPRESSION

  RESPIRATORY DEPRESSION OBSERVATION ONLY OF CURRENT PRACTICES, DOES NOT INVOLVE TREATMENT

  24 HOURS

Study Arms (1)

Cesearean sections receiving duramorph

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• Have known contraindication/allergy to neuraxial anesthesia or morphine.
• Have an ASA class \> III
• Age \> 55 years

Sponsors & Collaborators

• Wake Forest University: lead
• Forsyth Medical Center: collaborator

Study Sites (1)

Forsyth Medical Center-Dept of OB Anesthesia

Winston-Salem, North Carolina, 27103, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Pain, Postoperative

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Peter Pan, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2010
• First Posted: August 13, 2010
• Study Start: July 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: November 8, 2017

Record last verified: 2017-02

Locations

US (1)