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

NCT04692870 | Completed

• 1 other identifier: IRC/ 1872/ 020
• Study Type: observational
• Target: 337
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension

Keywords

cesarean section; hypotension; spinal anesthesia; shock index; post spinal hypotension; non-elective cesarean section

Outcome Measures

Primary Outcomes (1)

• Incidence of post spinal hypotension

  SBP \< 80% of baseline reading or SBP \< 100 mmHg after administering spinal anesthesia

  time points between administering spinal anesthesia and until delivery of baby before starting oxytocin during surgery

Secondary Outcomes (1)

• post-delivery hypotension

  During surgery from starting oxytocin after delivery of baby until the end of surgery

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• B.P. Koirala Institute of Health Sciences: lead

Study Sites (1)

Shirish Silwal

Dharān, Koshi, 56700, Nepal

Location

Related Publications (45)

• Yentis SM, Richards NA. Classification of urgency of caesarean section. Obstet Gynaecol Reprod Med. 2008;18(5):139-40

  BACKGROUND

• 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

  BACKGROUND

• Fitzgerald JP, Fedoruk KA, Jadin SM, Carvalho B, Halpern SH. Prevention of hypotension after spinal anaesthesia for caesarean section: a systematic review and network meta-analysis of randomised controlled trials. Anaesthesia. 2020 Jan;75(1):109-121. doi: 10.1111/anae.14841. Epub 2019 Sep 18.

  PMID: 31531852 BACKGROUND

• Sahoo T, SenDasgupta C, Goswami A, Hazra A. Reduction in spinal-induced hypotension with ondansetron in parturients undergoing caesarean section: a double-blind randomised, placebo-controlled study. Int J Obstet Anesth. 2012 Jan;21(1):24-8. doi: 10.1016/j.ijoa.2011.08.002. Epub 2011 Nov 18.

  PMID: 22100822 BACKGROUND

• 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

  BACKGROUND

• Somboonviboon W, Kyokong O, Charuluxananan S, Narasethakamol A. Incidence and risk factors of hypotension and bradycardia after spinal anesthesia for cesarean section. J Med Assoc Thai. 2008 Feb;91(2):181-7.

  PMID: 18389982 BACKGROUND

• Ngan Kee WD, Khaw KS, Lau TK, Ng FF, Chui K, Ng KL. Randomised double-blinded comparison of phenylephrine vs ephedrine for maintaining blood pressure during spinal anaesthesia for non-elective Caesarean section*. Anaesthesia. 2008 Dec;63(12):1319-26. doi: 10.1111/j.1365-2044.2008.05635.x.

  PMID: 19032300 BACKGROUND

• Sklebar I, Bujas T, Habek D. SPINAL ANAESTHESIA-INDUCED HYPOTENSION IN OBSTETRICS: PREVENTION AND THERAPY. Acta Clin Croat. 2019 Jun;58(Suppl 1):90-95. doi: 10.20471/acc.2019.58.s1.13.

  PMID: 31741565 BACKGROUND

• Bamber JH, Dresner M. Aortocaval compression in pregnancy: the effect of changing the degree and direction of lateral tilt on maternal cardiac output. Anesth Analg. 2003 Jul;97(1):256-8, table of contents. doi: 10.1213/01.ane.0000067400.79654.30.

  PMID: 12818977 BACKGROUND

• Campagna JA, Carter C. Clinical relevance of the Bezold-Jarisch reflex. Anesthesiology. 2003 May;98(5):1250-60. doi: 10.1097/00000542-200305000-00030. No abstract available.

  PMID: 12717149 BACKGROUND

• McCrae AF, Wildsmith JA. Prevention and treatment of hypotension during central neural block. Br J Anaesth. 1993 Jun;70(6):672-80. doi: 10.1093/bja/70.6.672.

  PMID: 8329261 BACKGROUND

• Bishop DG, Cairns C, Grobbelaar M, Rodseth RN. Obstetric spinal hypotension: Preoperative risk factors and the development of a preliminary risk score - the PRAM score. S Afr Med J. 2017 Nov 27;107(12):1127-1131. doi: 10.7196/SAMJ.2017.v107i12.12390.

  PMID: 29262969 BACKGROUND

• Butwick AJ, Columb MO, Carvalho B. Preventing spinal hypotension during Caesarean delivery: what is the latest? Br J Anaesth. 2015 Feb;114(2):183-6. doi: 10.1093/bja/aeu267. Epub 2014 Jul 30. No abstract available.

  PMID: 25080429 BACKGROUND

• Saravanan S, Kocarev M, Wilson RC, Watkins E, Columb MO, Lyons G. Equivalent dose of ephedrine and phenylephrine in the prevention of post-spinal hypotension in Caesarean section. Br J Anaesth. 2006 Jan;96(1):95-9. doi: 10.1093/bja/aei265. Epub 2005 Nov 25.

  PMID: 16311286 BACKGROUND

• 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

  BACKGROUND

• Bishop DG. Predicting spinal hypotension during caesarean section. Southern African Journal of Anaesthesia and Analgesia. 2015 ;1181:1-4

  BACKGROUND

• Frolich MA, Caton D. Baseline heart rate may predict hypotension after spinal anesthesia in prehydrated obstetrical patients. Can J Anaesth. 2002 Feb;49(2):185-9. doi: 10.1007/BF03020493.

  PMID: 11823398 BACKGROUND

• 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

  BACKGROUND

• Kinsella SM, Norris MC. Advance prediction of hypotension at cesarean delivery under spinal anesthesia. Int J Obstet Anesth. 1996 Jan;5(1):3-7. doi: 10.1016/s0959-289x(96)80067-7.

  PMID: 15321375 BACKGROUND

• Dahlgren G, Granath F, Wessel H, Irestedt L. Prediction of hypotension during spinal anesthesia for Cesarean section and its relation to the effect of crystalloid or colloid preload. Int J Obstet Anesth. 2007 Apr;16(2):128-34. doi: 10.1016/j.ijoa.2006.10.006. Epub 2007 Feb 5.

  PMID: 17276668 BACKGROUND

• Nani FS, Torres ML. Correlation between the body mass index (BMI) of pregnant women and the development of hypotension after spinal anesthesia for cesarean section. Rev Bras Anestesiol. 2011 Jan-Feb;61(1):21-30. doi: 10.1016/S0034-7094(11)70003-4.

  PMID: 21334504 BACKGROUND

• Orbach-Zinger S, Ginosar Y, Elliston J, Fadon C, Abu-Lil M, Raz A, Goshen-Gottstein Y, Eidelman LA. Influence of preoperative anxiety on hypotension after spinal anaesthesia in women undergoing Caesarean delivery. Br J Anaesth. 2012 Dec;109(6):943-9. doi: 10.1093/bja/aes313. Epub 2012 Sep 10.

  PMID: 22964265 BACKGROUND

• Fakherpour A, Ghaem H, Fattahi Z, Zaree S. Maternal and anaesthesia-related risk factors and incidence of spinal anaesthesia-induced hypotension in elective caesarean section: A multinomial logistic regression. Indian J Anaesth. 2018 Jan;62(1):36-46. doi: 10.4103/ija.IJA_416_17.

  PMID: 29416149 BACKGROUND

• Ohpasanon P, Chinachoti T, Sriswasdi P, Srichu S. Prospective study of hypotension after spinal anesthesia for cesarean section at Siriraj Hospital: incidence and risk factors, Part 2. J Med Assoc Thai. 2008 May;91(5):675-80.

  PMID: 18672631 BACKGROUND

• Bishop DG, Cairns C, Grobbelaar M, Rodseth RN. Heart rate variability as a predictor of hypotension following spinal for elective caesarean section: a prospective observational study. Anaesthesia. 2017 May;72(5):603-608. doi: 10.1111/anae.13813. Epub 2017 Jan 30.

  PMID: 28133720 BACKGROUND

• Rady MY, Nightingale P, Little RA, Edwards JD. Shock index: a re-evaluation in acute circulatory failure. Resuscitation. 1992 Jun-Jul;23(3):227-34. doi: 10.1016/0300-9572(92)90006-x.

  PMID: 1321482 BACKGROUND

• Zarzaur BL, Croce MA, Fischer PE, Magnotti LJ, Fabian TC. New vitals after injury: shock index for the young and age x shock index for the old. J Surg Res. 2008 Jun 15;147(2):229-36. doi: 10.1016/j.jss.2008.03.025. Epub 2008 Apr 10.

  PMID: 18498875 BACKGROUND

• Rau CS, Wu SC, Kuo SC, Pao-Jen K, Shiun-Yuan H, Chen YC, Hsieh HY, Hsieh CH, Liu HT. Prediction of Massive Transfusion in Trauma Patients with Shock Index, Modified Shock Index, and Age Shock Index. Int J Environ Res Public Health. 2016 Jul 5;13(7):683. doi: 10.3390/ijerph13070683.

  PMID: 27399737 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• Baraff LJ, Schriger DL. Orthostatic vital signs: variation with age, specificity, and sensitivity in detecting a 450-mL blood loss. Am J Emerg Med. 1992 Mar;10(2):99-103. doi: 10.1016/0735-6757(92)90038-y.

  PMID: 1586423 BACKGROUND

• Birkhahn RH, Gaeta TJ, Terry D, Bove JJ, Tloczkowski J. Shock index in diagnosing early acute hypovolemia. Am J Emerg Med. 2005 May;23(3):323-6. doi: 10.1016/j.ajem.2005.02.029.

  PMID: 15915406 BACKGROUND

• Jeon YT, Hwang JW, Kim MH, Oh AY, Park KH, Park HP, Lee Y, Do SH. Positional blood pressure change and the risk of hypotension during spinal anesthesia for cesarean delivery: an observational study. Anesth Analg. 2010 Sep;111(3):712-5. doi: 10.1213/ANE.0b013e3181e8137b. Epub 2010 Aug 4.

  PMID: 20686012 BACKGROUND

• Yokose M, Mihara T, Sugawara Y, Goto T. The predictive ability of non-invasive haemodynamic parameters for hypotension during caesarean section: a prospective observational study. Anaesthesia. 2015 May;70(5):555-62. doi: 10.1111/anae.12992. Epub 2015 Feb 12.

  PMID: 25676817 BACKGROUND

• 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

  BACKGROUND

• Pokharel K, Bhattarai B, Tripathi M, Khatiwada S, Subedi A. Nepalese patients' anxiety and concerns before surgery. J Clin Anesth. 2011 Aug;23(5):372-8. doi: 10.1016/j.jclinane.2010.12.011.

  PMID: 21802628 BACKGROUND

• Moerman N, van Dam FS, Muller MJ, Oosting H. The Amsterdam Preoperative Anxiety and Information Scale (APAIS). Anesth Analg. 1996 Mar;82(3):445-51. doi: 10.1097/00000539-199603000-00002.

  PMID: 8623940 BACKGROUND

• Berth H, Petrowski K, Balck F. The Amsterdam Preoperative Anxiety and Information Scale (APAIS) - the first trial of a German version. Psychosoc Med. 2007 Feb 20;4:Doc01.

  PMID: 19742298 BACKGROUND

• Klohr S, Roth R, Hofmann T, Rossaint R, Heesen M. Definitions of hypotension after spinal anaesthesia for caesarean section: literature search and application to parturients. Acta Anaesthesiol Scand. 2010 Sep;54(8):909-21. doi: 10.1111/j.1399-6576.2010.02239.x. Epub 2010 Apr 23.

  PMID: 20455872 BACKGROUND

• Vandenbroucke JP, von Elm E, Altman DG, Gotzsche PC, Mulrow CD, Pocock SJ, Poole C, Schlesselman JJ, Egger M; STROBE Initiative. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): explanation and elaboration. Epidemiology. 2007 Nov;18(6):805-35. doi: 10.1097/EDE.0b013e3181577511.

  PMID: 18049195 BACKGROUND

• Heesen M, Carvalho B, Carvalho JCA, Duvekot JJ, Dyer RA, Lucas DN, McDonnell N, Orbach-Zinger S, Kinsella SM. International consensus statement on the use of uterotonic agents during caesarean section. Anaesthesia. 2019 Oct;74(10):1305-1319. doi: 10.1111/anae.14757. Epub 2019 Jul 25.

  PMID: 31347151 BACKGROUND

• Ali Algadiem E, Aleisa AA, Alsubaie HI, Buhlaiqah NR, Algadeeb JB, Alsneini HA. Blood Loss Estimation Using Gauze Visual Analogue. Trauma Mon. 2016 May 3;21(2):e34131. doi: 10.5812/traumamon.34131. eCollection 2016 May.

  PMID: 27626017 BACKGROUND

• 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

  BACKGROUND

• Mohta M, Aggarwal M, Sethi AK, Harisinghani P, Guleria K. Randomized double-blind comparison of ephedrine and phenylephrine for management of post-spinal hypotension in potential fetal compromise. Int J Obstet Anesth. 2016 Aug;27:32-40. doi: 10.1016/j.ijoa.2016.02.004. Epub 2016 Feb 21.

  PMID: 27020488 BACKGROUND

• Silwal S, Subedi A, Bhattarai B, Ghimire A. Association between preoperative shock index and hypotension after spinal anesthesia for non-elective cesarean section: a prospective cohort study. BMC Anesthesiol. 2024 Oct 23;24(1):383. doi: 10.1186/s12871-024-02766-5.

  PMID: 39443886 DERIVED

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior resident, Department of anesthesiology and critical care, BPKIHS, Nepal

Study Record Dates

• First Submitted: December 26, 2020
• First Posted: January 5, 2021
• Study Start: January 6, 2021
• Primary Completion: February 15, 2022
• Study Completion: February 25, 2022
• Last Updated: March 14, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)