- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05085652
Spinal Anesthesia Related Hypotension in SARS-CoV-2 (COVID-19) Pregnant Patients
Is SARS-CoV-2 (Covid-19) a Risk Factor for Hypotension During Spinal Anesthesia for Obstetric Patients?
Study Overview
Status
Intervention / Treatment
Detailed Description
The emergence of severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) which defined coronavirus disease 2019 (COVID-19) has prompted innumerable alterations in practice of anesthesiology. The nature of the association between COVID-19 and pregnancy outcomes remains unclear, and meta-analyses involving patients with COVID-19 who are pregnant are limited. A 2020 systematic review suggested that people who are pregnant did not have an increased risk of SARS-CoV-2 infection or symptomatic COVID19, but they were at risk of severe COVID-19 compared with those who were not. But unlike previous viral pandemics, COVID-19 incidence, prognosis and maternal and neonatal outcomes do not appear to be worse in pregnant women compared to that general population.
All of the potential complications of COVID 19 for pregnant and especially higher rate of aerosol transmission to the healthcare persons The American Society of Regional Anesthesia --- ASRA, the European Society of Regional Anesthesia and Pain Medicine --- ESRA and the European Society of Anesthesiology ---ESA published guidance on employing regional anesthesia for patients with COVID-19.
With regional anesthesia the risk of person-to-person transmission, which is 6,6 times higher during the respiratory procedures performed in general anesthesia getting minimalized.
In cesarean section for pregnant women with COVID-19 infection, all the questions for if the spinal anesthesia was safe and efficient in achieving satisfactory obstetrical anaesthesia? At the beginning of the pandemic in a retrospective analysis Chen et al reported that higher rate of hypotension after neuraxial blocks. After this study some questions about safety of the regional anesthesia appeared in the minds.
However, the effects of SARS-CoV-2 infection on hemodynamics of pregnancies who underwent neuraxial anesthesia for cesarean delivery are still unclear. In this study we retrospectively evaluated 249 COVID-19 patients in one center hospital in case the hypotension is the risk for the neuraxial block safety and if so, what we did to treat them?
Method:
After the approval of the local ethical committee approval, we used a retrospective analysis of 249 COVID 19 cesarean section spinal anesthesia to determine the incidence of hypotension and management strategies after the anesthesia. The study was carried out with the principles of the Helsinki Declaration. Medical records of pregnant women who were admitted into our hospital for cesarean section were retrospectively retrieved during the period of January 24, 2020 - February 29, 2021. The diagnosis criteria followed the guideline by the National Health Commission of Turkey and SARS-CoV-2 nucleic acid test was used to screen COVID-19 in all patients. All ASA Physical Status II pregnant women who received cesarean delivery under neuraxial anesthesia were eligible for inclusion in the study.
Neuraxial anesthesia protocols for cesarean delivery was before the spinal anesthesia, an intravenous line, ECG, pulse oximetry, and non-invasive automatic blood pressure monitors (2-min interval) were placed. Spinal anesthesia was performed in the sitting position with 26-gauge atraucan spinal needle and heavy bupivacaine regards of the anesthesiologists through the L3-4 or L4-5 intervertebral spaces. All patients were delivered oxygen by nasal cannula under the surgical mask. All the patients placed in the supine position after puncture procedure until the end of the surgical procedure. All BP recordings in this study were performed with the patient in the supine position.
Neuraxial anesthesia-related hypotension was based on a single episode of defined hypotension from the time of local anesthetic injection until 15 min after delivery of the newborn. And hypotension was defined as systolic BP <80% of baseline or <90 mmHg and was treated with an intravenous bolus of ephedrine 5 mg, additional bolus of Ringer Lactates and colloid infusion hydroxyethyl starch solution (130/0.46% hydroxyethyl starch solution; Fresenius Kabi, Bad Homburg vor der Höhe, Germany). All the demographic-vital data's including systolic and diastolic blood pressure (SBP-DBP), ephedrine-atropine doses, crystalloids and colloid infusion volumes, newborn birth weight and nausea, vomiting was recorded too.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Type A Choice Below ...
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Ankara, Type A Choice Below ..., Turkey, 06810
- Aygün Güler
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- SARS-CoV-2 nucleic acid test positive COVID-19 all ASA Physical Status I- II pregnant women who received cesarean delivery under neuraxial anesthesia were eligible for inclusion in the study.
Exclusion Criteria:
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Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
hypotensive COVID19 patients
Neuraxial anesthesia-related hypotension was based on a single episode of defined hypotension from the time of local anesthetic injection until 15 min after delivery of the newborn.
And hypotension was defined as systolic blood pressure <80% of baseline or <90 mmHg and was treated with an intravenous bolus of ephedrine 5 mg, additional bolus of Ringer Lactates and colloid infusion hydroxyethyl starch solution.
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SARS-CoV-2 infection prognosis remains unclear during pregnancy.
according to ESA, ASRA and WHO regional anesthesia was recommended to use for caesarian section procedures.
But at the beginning of the pandemic Chen et al shared their retrospective analyses about regional anesthesia for caesarian section and they showed high spinal anesthesia induced hypotension in 14 patients of the 17 and also again Chen and Zahng et al made another study and this time they found 57,4% hypotension incidence.
In our study we aimed to find if the spinal anesthesia safe procedure in the 249 patients and one center hospital.
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non-hypotensive COVID19 patients
from the time of local anesthetic injection until 15 min after delivery of the newborn no hypotension was seen.
systolic blood pressure > 80% of baseline or >90 mmHg.
no medical treatment needed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
hypotension
Time Frame: From the time of local anesthetic injection to subarachnoid space until 15 min after delivery of the newborn.
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Systolic Blood Pressure <80% of baseline or <90 mmHg.
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From the time of local anesthetic injection to subarachnoid space until 15 min after delivery of the newborn.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aygün Güler, Ankara City Hospital Bilkent
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- COVID-19
- Hypotension
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Anesthetics
Other Study ID Numbers
- 72300690-799-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Study Data/Documents
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Clinical Study Report
Information comments: Chen R, Zhang Y, Huang L, Cheng B, Xia Z, Meng Q. Safety and efficacy of different anesthetic regimens for parturients with COVID-19 undergoing cesarean delivery: a case series of 17 patients. Can J Anesth. 2020. DOI: https://doi.org/10.1007/s12630-020-01630-7
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Clinical Study Report
Information comments: 12- Zhang Y, Chen R, Cao C, et al. The Risk of Neuraxial Anesthesia-Related Hypotension in COVID-19 Parturients Undergoing Cesarean Delivery: A Multicenter, Retrospective, Propensity Score Matched Cohort Study. Front Med (Lausanne). 2021;8:713733. Published 2021 Aug 19. doi:10.3389/fmed.2021.713733
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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