SARS-CoV-2 PANDEMIC AND FAILED SPINAL ANESTHESIA

October 18, 2021 updated by: Ankara City Hospital Bilkent

SARS-CoV-2 PANDEMIC AND FAILED SPINAL ANESTHESIA: A NIGHTMARE

The investigators used a retrospective review of 251 SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) positive patients' cesarean section anesthesia to determine the rate of failed spinal anesthesia, management techniques for failed block, and risk factors that contribute to failure in this study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

All anesthesiologists face a challenge when it comes to the anesthesia of patients with coronavirus disease who are going to have a cesarian section. Patients' and healthcare personnel' safety should be prioritized. Non-emergent procedures in patients with respiratory infections, such as COVID-19 (Coronavirus disease 2019), should be postponed and rescheduled once the infection has been treated. However, some emergency treatments, such as cesarian section, cannot be postponed. So, for COVID 19 patients, which method should be used? According to past studies, the risk of maternal death is 16,7 times higher with general anesthesia than with regional anesthesia (1). Furthermore, general anesthesia, which requires aerosol-generating procedures such as ventilating and intubating patients, has a higher risk of respiratory problems during or after surgery than regional anesthesia. Earlier data on pregnant patients during the COVID 19 pandemic showed no difference in COVID 19-related mortality between pregnant and non-pregnant patients, but a recent study found that pregnancy is associated with a 70% greater risk of death. Another important point is that, when compared to those who are not exposed to tracheal intubation, the transfer of acute respiratory infection to a health care professional during tracheal intubation is 6.6 times higher.

For such reasons, the European and American Societies of Regional Anesthesia jointly issued COVID 19 recommendations stating that regional anesthesia should be preferred over general anesthesia whenever possible, and practice recommendations for regional anesthesia during the pandemic have already been published.

In addition, the American Society of Anesthesiologists and the Society for Obstetric Anesthesiology and Perinatology advise doctors to "consider using neuraxial methods rather than general anesthesia for most cesarian deliveries." In many facilities, single-shot spinal anesthesia is the preferred method for cesarian section. It delivers great anesthesia because of its ease of use, rapid onset of sensory and motor blockage, reliability, ease of mastering, and capacity to provide optimal surgical circumstances; it also minimizes the hazards of general anesthetic while enhancing partition satisfaction. In addition, when compared to general anesthesia, the risk of complications such intraoperative bleeding, surgical site infection, and postoperative pain is lower with spinal anesthesia.

In 1899, August Bier proclaimed spinal anesthesia to be a failure, stating, "Experienced professional, correct technique, single puncture, adequate CSF backflow, effective anesthetic agent!" So, why did it fail? -Capriciousness!!" Single shot spinal anesthesia failure may occur when the subarachnoid space is not reached, or analgesia is not sufficient for surgery after injection. The issue is that if anesthesia fails during COVID 19 procedures, we'll need to develop a new approach for supplementing anesthesia and analgesia cautiously, quickly, and meticulously.

Failed spinal anesthesia can be partial or complete. If anesthesia and analgesia are not achieved within ten minutes after successful intrathecal injection, the bupivacaine spinal anesthetic is regarded to have failed. Partial failure was defined as insufficient extent, quality, or duration of pharmacological action for that procedure, while complete failure was described as no sensory or motor blockage.

Failure of spinal anesthesia necessitates extreme caution, judgment, and technique. If surgery has not yet begun, a partial or total failure can be managed by increasing the Trendelenburg position or administering a second spinal anesthetic. However, if the surgery has already begun, it can be managed by changing positions, injecting local anaesthetic in the operation area by the surgeon, administering sedation with oxygen, opioids, benzodiazepines, or ketamine, and then converting the anesthesia to general anesthesia.

The failure rate of spinal anesthesia is widely distributed, according to researches, ranging from 1 to 17 percent. During spinal anesthesia, the Royal College of Anesthetics proposes a failure rate of 3% in emergencies and 1% for elective procedures. The goal of this study was to determine failure rate and solutions for spinal anesthesia in the context of a COVID 19 pandemic.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
251

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Type A Choice Below ...
      • Ankara, Type A Choice Below ..., Turkey, 06810
        • Aygün Güler

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

we included records of spinal anesthesia performed on confirmed COVID 19 patients in the Ankara City Hospital between April 2020 and February 2021

Description

Inclusion Criteria:

  • we included records of spinal anesthesia performed on confirmed COVID 19 patients in the Ankara City Hospital between April 2020 and February 2021

Exclusion Criteria:

  • Patients who did not have their data gathered, or whose operation took more than 3 hours due to any reason, were excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
SARS-CoV-2 pregnant women
After receiving approval from the local ethics committee and permission to use the hospital archives, we included records of spinal anesthesia performed on confirmed SARS- CoV-2 patients in the Ankara City Hospital between April 2020 and February 2021, as well as related data, in our study. Patients who did not have their data gathered, or whose operation took more than 3 hours due to any reason, were excluded from the study
Procedure: covid 19 spinal anesthesia
this group description covers that all the covid 19 pregnant women which we gave spinal anesthesia for cesarean section procedures. The investigators analyzed them retrospectively.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The percentage of failed spinal block
Time Frame: Between implementation of spinal anesthesia to the end of the surgery
the percentage of failed spinal anesthesia among SARS-CoV-2 positive pregnants who underwent cesarean section under spinal anesthesia
Between implementation of spinal anesthesia to the end of the surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
reasons of failure of spinal block
Time Frame: between implementation of spinal anesthesia to the end of the surgery
possible reasons of inadequate spinal block among SARS-CoV-2 positive parturients who underwent cesarean section under spinal anesthesia
between implementation of spinal anesthesia to the end of the surgery
management of failed spinal anesthesia
Time Frame: between implementation of spinal anesthesia to the end of the surgery
anesthesia, sedation methods to manage failed spinal block for SARS-CoV-2 positive parturients who underwent cesarean section under spinal anesthesia
between implementation of spinal anesthesia to the end of the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara City Hospital Bilkent

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Aygün Güler, md, Ankara City Hospital Bilkent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 12, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 7, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 72300690-799

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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