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Association Between Preoperative Shock Index and Hypotension After Spinal Anaesthesia for Non- Elective Caesarean Section

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ClinicalTrials.gov Identifier: NCT04692870
Recruitment Status : Recruiting
First Posted : January 5, 2021
Last Update Posted : January 7, 2021
Sponsor:
Information provided by (Responsible Party):
Shirish Silwal, B.P. Koirala Institute of Health Sciences

Brief Summary:
This is a prospective observational study done in parturient planned for non-elective caesarean section. Association between shock index (HR/SBP) and post-spinal hypotension in parturient undergoing non-elective caesarean section will be evaluated in this research.

Condition or disease
Hypotension

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 337 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Association Between Preoperative Shock Index and Hypotension After Spinal Anaesthesia for Non-elective Caesarean Section: A Prospective Observational Study
Actual Study Start Date : January 6, 2021
Estimated Primary Completion Date : December 14, 2021
Estimated Study Completion Date : January 14, 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Incidence of post spinal hypotension [ Time Frame: time points between administering spinal anesthesia and until delivery of baby before starting oxytocin during surgery ]
    SBP < 80% of baseline reading or SBP < 100 mmHg after administering spinal anesthesia


Secondary Outcome Measures :
  1. post-delivery hypotension [ Time Frame: During surgery from starting oxytocin after delivery of baby until the end of surgery ]
    < 80% of baseline reading or SBP < 100 mmHg observed



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients at term undergoing emergency caesarean delivery and falling under category 2 (no immediate threat to life of pregnant women and fetus) and category 3 (requiring early delivery) according to NICE (National Institute for Clinical Excellence) guideline classification of urgency of emergency caesarean section and ASA (American society of Anaesthesiologist) PS (Physical status) grade II under spinal anesthesia will be included.
Criteria

Inclusion Criteria:

  • All parturient at term (gestational weeks ≥ 37)
  • ASA (American society of Anesthesiologist) PS (Physical status) grade II
  • Category 2 and 3 of non-elective caesarean section

Exclusion Criteria:

  • ASA PS Grade >2
  • Pregnancy induced hypertension
  • Gestational hypertension
  • Known fetal abnormalities
  • Contraindications to spinal anesthesia
  • Multiple pregnancy
  • Baseline SBP< 100 mmHg
  • Intrauterine growth restriction (IUGR)
  • Missing height and/ or weight data
  • Stillbirth
  • Height: <150 cm
  • Ante-partum hemorrhage
  • Cardiovascular, cerebrovascular disease, endocrine disease
  • Gestational diabetes
  • Failed spinal anesthesia requiring GA

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04692870


Contacts
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Contact: Shirish Silwal, MD/MS 9841990775 shirish1992backup@gmail.com
Contact: Asish Subedi, MD/ MS 9842040604 asishsubedi19@gmail.com

Locations
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Nepal
Shirish Silwal Recruiting
Dharān Bāzār, Province 1, Nepal, 56700
Contact: Shirish Silwal    9841990775    shirish1992backup@gmail.com   
Sub-Investigator: Asish Subedi, MD/MS         
Sub-Investigator: Balkrishna Bhattrai, MD/MS         
Sub-Investigator: Satyanendra N Singh, MD/MS         
Sub-Investigator: Ashish Ghimire, MD/MS         
Principal Investigator: Shirish Silwal, MD/MS         
Sponsors and Collaborators
B.P. Koirala Institute of Health Sciences
Publications:
Yentis SM, Richards NA. Classification of urgency of caesarean section. Obstet Gynaecol Reprod Med. 2008;18(5):139-40
Kamat LL, Jha TR, Talnikar AS, Mahevi ZM, Save MP. Effect of Ondansetron in Attenuation of Post - Spinal Hypotension in Caesarean Section : A Comparison of Two Different Doses with Placebo. J Obstet Anaesth Crit Care 2017; 7 (2):69-74
Tang L, Tang L, Li S, Huang S, Chen L, Zhang J. Spinal anaesthesia for emergency caesarean section better using 25-gauge pencil point needle or 22-gauge cutting needle: a single centre prospective study. International Journal of research in medical sciences, 2017;10(8):12293-12300
Adıyeke E. Is the Emergency Cesarean Section associated with Hypotension ? Retrospective Analysis of 80 Patients Undergoing Elective or Emergency Cesarean Section under Spinal Anesthesia. Haydarpasa Numune Medical Journal 2019;59(4):342-346
Bishop DG. Predicting spinal hypotension during caesarean section. Southern African Journal of Anaesthesia and Analgesia. 2015 ;1181:1-4
Joshi M, Raghu K, Rajaram G, Nikhil N, Kumar S, Singh A. Baseline heart rate as a predictor of post-spinal hypotension in patients undergoing a caesarean section: An observational study. J Obstet Anaesth Crit Care. 2018;8(1):20- 23
Sotello D, Yang S, Nugent K. Comparison of the shock index, modified shock index, and age shock index in adult admissions to a tertiary hospital. Southwest Respir Crit Care Chronicles. 2019;7(28):18-23
Durukan P, Ikizceli I, Akdur O, Özkan S, Sözüer EM, Avşaroǧullari L, et al. Use of the shock index to diagnose acute hypovolemia. Turkish J Med Sci. 2009;39(6):833-835
Manouchehrian N, Torabi F, Shayan A, Otogara M. Investigation of effect of blood pressure and heart rate changes in different positions (lying and sitiing) on hypotension incidence rate after spinal anesthesia in patients undegoing caesarean section. International Journal of Medical Research and Health sciences; 2016; 5 (7S): 407- 412
Peduzzi P, Concato J, Feinstein AR, Halford TR. A18 A simulation study of the number of events per variable recommended in multivariable regression analyses. Control Clin Trials. 1993;14(5):406

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Responsible Party: Shirish Silwal, Junior resident, Department of anesthesiology and critical care, BPKIHS, Nepal, B.P. Koirala Institute of Health Sciences
ClinicalTrials.gov Identifier: NCT04692870    
Other Study ID Numbers: IRC/ 1872/ 020
First Posted: January 5, 2021    Key Record Dates
Last Update Posted: January 7, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Shirish Silwal, B.P. Koirala Institute of Health Sciences:
cesarean section
hypotension
spinal anesthesia
shock index
post spinal hypotension
non-elective cesarean section
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases