Incidence of Respiratory Depression in Cesarean Section

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01181843
• Other study ID #: FMC IRB 2010.200
• Status: Terminated
• Phase: N/A
• First received: August 12, 2010
• Last updated: November 6, 2017
• Start date: July 2010
• Est. completion date: June 2014

Study information

• Verified date: February 2017
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Pain, Postoperative
• Postoperative Pain
• Respiratory Depression
• Respiratory Insufficiency

Locations

Country	Name	City	State
United States	Forsyth Medical Center-Dept of OB Anesthesia	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University	Forsyth Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RESPIRATORY DEPRESSION	RESPIRATORY DEPRESSION OBSERVATION ONLY OF CURRENT PRACTICES, DOES NOT INVOLVE TREATMENT	24 HOURS