Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05085652 |
| Other study ID # |
72300690-799-1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 24, 2020 |
| Est. completion date |
February 28, 2021 |
Study information
| Verified date |
October 2021 |
| Source |
Ankara City Hospital Bilkent |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Since the onset of COVID-19, recommendations suggest the use of neuraxial anesthesia, if
possible, over general anesthesia for cesarian section to avoid the risks of aerosolization
associated with tracheal intubation and extubation. But the safety of performing spinal
anesthesia is unclear especially for post spinal hypotension, during the presence of active
infection with COVID-19. Since at the beginning of the pandemic a few studies reported
significant hypotension during epidural anesthesia in COVID-19 pregnant women, there was a
controversial discussion about the safety of regional anesthesia was started. In this study
we aimed to find if spinal anesthesia is safely recommended anesthesia type for COVID-19
obstetric patients. 249 patients with PCR confirmed COVID-19 for cesarean section undergoing
spinal anesthesia in Ankara City Hospital, Ankara assessed in this retrospective study to
find if the hypotension is the risk factor for the COVID-19 patients.
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.
