Clinical trial NCT02417038: Postoperative Respiratory Monitoring After Neuraxial Opioid Administration for Cesarean Delivery
Official title: Postoperative Respiratory Monitoring After Neuraxial Opioid Administration for Cesarean Delivery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Depression
Keywords: Postoperative Respiratory Monitoring
Neuraxial Opioid Administration for Cesarean Delivery
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2015-04-15
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women undergoing cesarean delivery with neuraxial anesthesia.

Brief summary: Respiratory depression occurs in labor and delivery; noticeably when neuraxial opioids are given.Pathophysiological respiratory depression -failure to respond to hypercapnia or hypoxia - is challenging to measure clinically.American Society of Anesthesiologist guidelines recommend suitable respiratory monitoring for 24 hours post cesarean delivery (CD).

Use of capnograph will enable us to assess breath-by-breathe respiration in a population receiving neuraxial opioids - potentially at risk for respiratory depression.

Our aim is to assess our ability to capture maternal postpartum respiratory parameters in a cohort following opioid neuraxial administration for CD.

Detailed description: The investigators wish to test the efficacy of capnograph in detection of apnea and respiratory depression in women following cesarean delivery. Currently, routine intensive monitoring such as the investigators propose is not performed, and many apneas may go undetected.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status class I or II
* Age between 18 and 45
* Gestational age greater than 37 completed weeks
* Singleton pregnancy.

Exclusion Criteria:

* Contraindication for neuraxial analgesia (bleeding diathesis, neuropathy, severe scoliosis, previous spine surgery, local anesthetic allergy)
* Allergies to postoperative medication (opioids, NSAIDs, acetaminophen)
* Chronic opioid use
* Opioid administration in the previous 12 hours
* Inability to adequately understand the consent form
* Blocked nose or nasal deformity.

Primary outcomes:
measure: CO2 monitoring
timeFrame: 24 hrs
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital
state: California
Study officials:
affiliation: Stanford University
name: Brendan Carvalho, MD
role: PRINCIPAL_INVESTIGATOR
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citation: Weiniger CF, Akdagli S, Turvall E, Deutsch L, Carvalho B. Prospective Observational Investigation of Capnography and Pulse Oximetry Monitoring After Cesarean Delivery With Intrathecal Morphine. Anesth Analg. 2019 Mar;128(3):513-522. doi: 10.1213/ANE.0000000000003503.