HypotensionNCT05085652
Spinal Anesthesia Related Hypotension in SARS-CoV-2 (COVID-19) Pregnant Patients
An observational study of Hypotension and Regional Anesthesia Morbidity, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Hypotension, Regional Anesthesia Morbidity, SARS-CoV2 Infection
- What is being tested?
- spinal anesthesia induced hypotension in SARS-CoV-2 patients.
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 251 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Jan 2020to 28 Feb 2021
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: SARS-CoV-2 nuclec acid test positive ASA I-II pregnant who scheduled to cesarian section operations.
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aygün Güler
Ankara, Type A Choice Below ..., 06810
About this study
Official title: Is SARS-CoV-2 (Covid-19) a Risk Factor for Hypotension During Spinal Anesthesia for Obstetric Patients?
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.
Read the 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.
- Being tested
- spinal anesthesia induced hypotension in SARS-CoV-2 patients.
- Keywords
- spinal anesthesia, regional anesthesia for SARS-CoV-2, spinal anesthesia induced hypotension
- Medical subject headings
- Hypotension, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal anesthesia induced hypotension in SARS-CoV-2 patients.Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: spinal anesthesia induced hypotension in SARS-CoV-2 patients. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
hypotension
Systolic Blood Pressure <80% of baseline or <90 mmHg.
Measured: From the time of local anesthetic injection to subarachnoid space until 15 min after delivery of the newborn.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start24 Jan 2020
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aygun cuhadar, Ankara City Hospital Bilkent
- Investigators
- Aygün Güler, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05085652
- Sponsor's protocol ID
- 72300690-799-1
- Status last verified
- Oct 2021
- First submitted
- 10 Oct 2021
- Last updated
- 20 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is SARS-CoV-2 (Covid-19) a Risk Factor for Hypotension During Spinal Anesthesia for Obstetric Patients?
- ClinicalTrials.gov ID
- NCT05085652
- Acronym / sponsor ID
- 72300690-799-1
- Keywords
- spinal anesthesia, regional anesthesia for SARS-CoV-2, spinal anesthesia induced hypotension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 24 Jan 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 20 Oct 2021 (actual)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypotensive COVID19 patients | – | Procedure: spinal anesthesia induced hypotension in SARS-CoV-2 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. |
| 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- SARS-CoV-2 nuclec acid test positive ASA I-II pregnant who scheduled to cesarian section operations.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spinal anesthesia induced hypotension in SARS-CoV-2 patients.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. | Procedure or surgery | hypotensive COVID19 patients |
Primary outcome
hypotension
Time frame: From the time of local anesthetic injection to subarachnoid space until 15 min after delivery of the newborn.
Systolic Blood Pressure <80% of baseline or <90 mmHg.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- Individual participant dataSharing planned: Undecided
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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.
Aygün Güler principal investigator
Ankara City Hospital Bilkent
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 Hypotension and Regional Anesthesia Morbidity, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 20 Oct 2021. 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 Turkey (Türkiye). 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
hypotension (time frame: From the time of local anesthetic injection to subarachnoid space until 15 min after delivery of the newborn.). 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 20 Oct 2021.