- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04692870
Association Between Preoperative Shock Index and Hypotension After Spinal Anaesthesia for Non- Elective Caesarean Section
Association Between Preoperative Shock Index and Hypotension After Spinal Anaesthesia for Non-elective Caesarean Section: A Prospective Observational Study
Study Overview
Status
Conditions
Detailed Description
Studies have shown that early hypovolemia is insufficient to produce changes in orthostatic heart rate (HR) or systolic blood pressure (SBP). Studies have shown that Shock Index (SI) as a useful indicator for acute hypovolemia. In healthy individuals, acute blood loss less than 450 mL rarely produces abnormal HR or SBP. As, several studies have shown that relationship of baseline heart rate and systolic blood pressure in predicting post spinal hypotension, this study aims to incorporate both the parameters and attempt to develop a single effective predictor for post spinal hypotension in the form of SI.
Methodology After approval from Institutional Review committee of B.P. Koirala Institute of Health Sciences, parturient undergoing non-elective caesarian of ASA PS grade II and urgency category 2 and 3, fulfilling the inclusion criteria will be informed about the study and written consent will be obtained either in labour room or in obstetric emergency ward. During this visit patient's data that includes age, indication of caesarean section, preoperative anxiety (APAIS), gestational age, and duration of fasting, height, weight, BMI and preoperative hemoglobin concentration will be recorded.
The study will be conducted in accordance with the ethical principles of the 1964 Declaration of Helsinki and STROBE (Strengthening the Reporting of Observational studies in Epidemiology) guidelines will be followed. Before patient is shifted to the operating room (OR), ranitidine 50 mg and metoclopramide 10 mg will be administered intravenously via 18 G cannula. The patient will be shifted to operating table and standard monitors 3 lead ECG, pulse oximetry and noninvasive blood pressure will be attached. Baseline vital signs heart rate and noninvasive SBP will be recorded in operation theatre in supine position with 15° left lateral tilt before administering spinal anaesthesia. NIBP will be measured by using cuff size with width of cuff bladder covering at least 40% of arm circumference and length at least 80% and will be measured from EDAN elite V8 monitors. 3 measurements of SBP will be recorded at 1 minute interval and its mean value will be taken as baseline SBP.
Also, shock index (HR/ SBP) will be calculated before administering spinal anaesthesia. At every 1 minute interval until delivery of baby, vitals parameters HR, SBP and MAP will be measured and shock index will be calculated in each time interval. Then, the patient will be placed in sitting position. Under all aseptic precautions, 2.2 ml of 0.5% hyperbaric bupivacaine with 10 µg fentanyl will be administered in sitting position in L4- L5 or L3- L4 interspace after confirmation of free flow of CSF with 25 G Quincke's needle and drug will be injected over 20 secs. Patient will be then immediately put into supine position with a right hip wedge. A 1 L co-loading of Ringer's lactate will be administered rapidly within 10 minutes via an 18 G intravenous line after administering spinal anaesthesia. Phenylepinephrine infusion will be started at 25 microgram/min immediately after the spinal injection. The sensory level of anaesthesia will be checked using loss of cold sensation with the use of alcohol soaked cotton swabs every minute until 20 mins. Surgery will be allowed once the bilateral sensory block height at T6 is achieved. Oxygen at 40% will be administered via nasal cannula at 2-4 L/min until delivery.
Hemodynamic parameters will be recorded at following time intervals: baseline, immediately after spinal anaesthesia, every minute for the first 15 minutes after spinal injection and every 2.5 mins until end of surgery. Hypotension will be treated with phenylephrine 50 µg bolus and rapid infusion of Ringer's lactate 200 ml. If bradycardia (HR< 55/min) is associated with hypotension, IV ephedrine 6 mg will be administered. If these measures fail and bradycardia is still persistent then an IV atropine 0.5 mg will be given. Intraoperative hypertension (defined as SBP greater than 120% of the baseline reading) will be managed by stopping norepinephrine infusion. The infusion will be resumed when blood pressure returns to the upper limit of the target range i.e. 20% above baseline.After delivery of the baby, 3 IU of oxytocin will be administered IV over ≥ 30 sec followed by an infusion of 10 IU/hr (oxytocin 40 IU in 500 ml of Hartmann's solution).
The total amount of intraoperative IV fluids administered and estimated blood loss will be measured. At the conclusion of the surgery, blood loss will be estimated by cumulative measurement of the following: the volume of blood in the suction canister (and subtracting the estimated amniotic fluid from the suction chamber); visual examination of the surgical sponges.
Intraoperative use of other uterotonic agent or blood transfusion will be recorded. The attending pediatrician will assess neonatal Apgar scores at 1 and 5 minutes after delivery.
Patients will be asked to report the occurrence of intraoperative nausea Incidence of intraoperative pruritus, shivering, and dizziness will also be recorded.
The primary outcome measures will be incidence of post spinal hypotension defined as SBP < 80% of baseline reading or SBP < 100 mmHg after administering of spinal anaesthesia until delivery of baby. The secondary outcome measures will be post-delivery hypotension is defined as SBP < 80% of baseline reading or SBP < 100 mmHg observed from starting oxytocin until end of surgery.
Data collection Baseline data (gestational age, preoperative hemoglobin, preoperative anxiety, uterine incision to delivery time, hemodynamic parameters) and outcome parameters will be collected in the paper case record form and entered in windows Microsoft excel spreadsheet and will use STATA version 15.0 for analysis.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Province 1
-
Dharān Bāzār, Province 1, Nepal, 56700
- Shirish Silwal
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
time points between administering spinal anesthesia and until delivery of baby before starting oxytocin during surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
During surgery from starting oxytocin after delivery of baby until the end of surgery
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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
- 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.
- 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.
- 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.
- 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. Erratum In: Anaesthesia. 2017 Nov;72 (11):1427.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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
- 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. Erratum In: J Clin Anesth. 2014 Feb;26(1):88.
- 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.
- 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.
- 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
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRC/ 1872/ 020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Hypotension
-
Academisch Medisch Centrum - Universiteit van Amsterdam...Edwards LifesciencesCompletedHypotension | Intraoperative Hypotension | Postoperative HypotensionNetherlands
-
James J. Peters Veterans Affairs Medical CenterCompleted
-
Attikon HospitalRecruitingHypotension During Surgery | Prevention of HypotensionGreece
-
Fondazione Policlinico Universitario Agostino Gemelli...Not yet recruitingHypotension Drug-Induced | Hypotension During Surgery
-
Universitätsklinikum Hamburg-EppendorfCompletedBlood Pressure | Postinduction Hypotension | Perioperative HypotensionGermany
-
University of ParmaUnknownHypotension During Dialysis | Dialysis HypotensionItaly
-
Peking Union Medical College HospitalRecruitingPost-induction Hypotension | Postprandial HypotensionChina
-
H. Lundbeck A/SCompletedSymptomatic Neurogenic Orthostatic HypotensionUnited States
-
Mazovia Regional Hospital in SiedlceRecruitingAnesthesia | Hypotension on Induction | Perioperative Injury | Perioperative HypotensionPoland
-
Acibadem UniversityCompletedHypotension | Intraoperative Hypotension | Post-induction Hypotension | Post Anesthesia RecoveryTurkey