Respiratory DepressionNCT01181843
Incidence of Respiratory Depression in Cesarean Section
An observational study of Respiratory Depression and Postoperative Pain, run by Wake Forest University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Respiratory Depression, Postoperative Pain
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Study population: subjects having an elective cesearean section and having as their anesthetic either a spinal or epidural and receiving duramorph
Who may be able to join
- 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
Who cannot join
- Have known contraindication/allergy to neuraxial anesthesia or morphine.
- Have an ASA class > III
- Age > 55 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Forsyth Medical Center-Dept of OB Anesthesia
Winston-Salem, North Carolina, 27103
About this study
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
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
- Medical subject headings
- Respiratory Insufficiency, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cesearean sections receiving duramorph | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
RESPIRATORY DEPRESSION
RESPIRATORY DEPRESSION OBSERVATION ONLY OF CURRENT PRACTICES, DOES NOT INVOLVE TREATMENT
Measured: 24 HOURS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: departmental financial support withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Collaborators
- Forsyth Medical Center
- Responsible party
- Sponsor
- Investigators
- Peter Pan, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01181843
- Sponsor's protocol ID
- FMC IRB 2010.200
- Status last verified
- Feb 2017
- First submitted
- 12 Aug 2010
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01181843
- Acronym / sponsor ID
- FMC IRB 2010.200
- Conditions
- Respiratory Depression, Postoperative Pain
- Keywords
- postoperative pain management, respiratory depression, capnography, duramorph
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: departmental financial support withdrawn
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Collaborators
- Forsyth Medical Center
- Study start
- Jul 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 13 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cesearean sections receiving duramorph | – | – |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- subjects having an elective cesearean section and having as their anesthetic either a spinal or epidural and receiving duramorph
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Have known contraindication/allergy to neuraxial anesthesia or morphine.
- Have an ASA class > III
- Age > 55 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
RESPIRATORY DEPRESSION
Time frame: 24 HOURS
RESPIRATORY DEPRESSION OBSERVATION ONLY OF CURRENT PRACTICES, DOES NOT INVOLVE TREATMENT
Results and safety
The study was stopped early (reason given: departmental financial support withdrawn). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2017.
Related trials for Respiratory Depression
Not yet recruiting
Lung Cancer and Aging: Improving Well-being for Older Adults With Lung Cancer
Lung Cancer
RecruitingObservational study
TIDES 2.0: Prevalence and Longitudinal Course of Depression, Anxiety, and Behavior Problems in Children With Cystic Fibrosis Under 12 Years of Age
Cystic Fibrosis (CF)
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
Not yet recruiting
R34 Asthma Depression
Asthma, Depression
Recruiting
The Effect of Diaphragmatic Breathing Exercises on Pain, Dyspnea, Posture, Body Awareness, Anxiety, and Depression in Young Adults
Young
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Pan, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Depression and Postoperative Pain, run by Wake Forest University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: departmental financial support withdrawn). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RESPIRATORY DEPRESSION (time frame: 24 HOURS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2017.