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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01181843

Enrollment

100

Registered

2010-08-13

Start date

2010-07-31

Completion date

2014-06-30

Last updated

2017-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain, Respiratory Depression

Keywords

postoperative pain management, respiratory depression, capnography, duramorph

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results