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临床试验/NCT04692870
NCT04692870已完成不适用

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

B.P. Koirala Institute of Health Sciences1 个研究点 分布在 1 个国家目标入组 337 人开始时间: 2021年1月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
337
试验地点
1
主要终点
Incidence of post spinal hypotension

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Incidence of post spinal hypotension

时间窗: 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

次要结局

  • post-delivery hypotension(During surgery from starting oxytocin after delivery of baby until the end of surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shirish Silwal

Junior resident, Department of anesthesiology and critical care, BPKIHS, Nepal

B.P. Koirala Institute of Health Sciences

研究点 (1)

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