Clinical trial NCT05085652: Spinal Anesthesia Related Hypotension in SARS-CoV-2 (COVID-19) Pregnant Patients
Official title: Is SARS-CoV-2 (Covid-19) a Risk Factor for Hypotension During Spinal Anesthesia for Obstetric Patients?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypotension
Regional Anesthesia Morbidity
SARS-CoV2 Infection
Keywords: spinal anesthesia
regional anesthesia for SARS-CoV-2
spinal anesthesia induced hypotension
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2021-10-20
Enrollment: 251
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: SARS-CoV-2 nuclec acid test positive ASA I-II pregnant who scheduled to cesarian section operations.

Brief 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.

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: hypotension
timeFrame: From the time of local anesthetic injection to subarachnoid space until 15 min after delivery of the newborn.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Aygün Güler
state: Type A Choice Below ...
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Aygün Güler
role: PRINCIPAL_INVESTIGATOR
References: