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HypotensionNCT04692870

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

An observational study of Hypotension, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 years, women only
Conditions the study is for
Hypotension
How many people
337 participants
Where
1 siteNepal
Study dates
6 Jan 2021to 25 Feb 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

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.

Who may be able to join

  • 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

Who cannot join

  • ASA PS Grade >2
  • Pregnancy induced hypertension
  • Gestational hypertension
  • Known fetal abnormalities
  • Contraindications to spinal anesthesia
  • Multiple pregnancy
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Nepal1 site
  • Shirish Silwal

    Dharān, Koshi, 56700

Other trials in Nepal

About this study

Official title: Association Between Preoperative Shock Index and Hypotension After Spinal Anaesthesia for Non-elective Caesarean Section: A Prospective Observational Study

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.

Read the 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.

Conditions
Hypotension
Keywords
cesarean section, hypotension, spinal anesthesia, shock index, post spinal hypotension, non-elective cesarean section
Medical subject headings
Hypotension

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of post spinal hypotension

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

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

Secondary outcomes (1)
  1. post-delivery hypotension

    < 80% of baseline reading or SBP < 100 mmHg observed

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2021
  2. Study start6 Jan 2021
  3. Primary completion15 Feb 2022
  4. Study completion25 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
337 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04692870
Sponsor's protocol ID
IRC/ 1872/ 020
Status last verified
Mar 2022
First submitted
26 Dec 2020
Last updated
14 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

  • 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.

    PubMed 31531852
  • 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.

    PubMed 22100822
  • 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.

    PubMed 18389982
  • 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.

    PubMed 19032300
  • 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.

    PubMed 31741565
  • 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.

    PubMed 12818977
  • 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.

    PubMed 12717149
  • 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.

    PubMed 8329261
  • 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.

    PubMed 29262969
  • 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.

    PubMed 25080429
  • 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.

    PubMed 16311286
  • 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

Questions about this trial

What is this clinical trial studying?

An observational study of Hypotension, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of post spinal hypotension (time frame: time points between administering spinal anesthesia and until delivery of baby before starting oxytocin during surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04692870, which also lists 45 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2022.

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