Spinal Anesthesia Related Hypotension in SARS-CoV-2 (COVID-19) Pregnant Patients

NCT05085652 | Completed

• 1 other identifier: 72300690-799-1
• Study Type: observational
• Target: 251
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension; Regional Anesthesia Morbidity; SARS-CoV2 Infection

Keywords

spinal anesthesia; regional anesthesia for SARS-CoV-2; spinal anesthesia induced hypotension

Outcome Measures

Primary Outcomes (1)

• hypotension

  Systolic Blood Pressure \<80% of baseline or \<90 mmHg.

  From the time of local anesthetic injection to subarachnoid space until 15 min after delivery of the newborn.

Study Arms (2)

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.

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.

Interventions

spinal anesthesia induced hypotension in SARS-CoV-2 patients. PROCEDURE

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.

hypotensive COVID19 patients

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

SARS-CoV-2 nuclec acid test positive ASA I-II pregnant who scheduled to cesarian section operations.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Aygün Güler

Ankara, Type A Choice Below ..., 06810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypotension; COVID-19

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Aygün Güler

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: anesthesiology and reanimation specialist, MD, primer investigator

Study Record Dates

• First Submitted: October 10, 2021
• First Posted: October 20, 2021
• Study Start: January 24, 2020
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: October 20, 2021

Record last verified: 2021-10

Locations

TU (1)