A Study to Evaluate the Relationship between Body Mass Index (BMI) and Hypotension following Spinal Anaesthesia in Caesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- To evaluate the correlation between Body Mass Index (BMI) and incidence of episodes of hypotension following spinal anaesthesia in caesarean section
研究概览
简要总结
Hypotension after spinal anaesthesia is more prominent in parturient than in general population due to many factors; for example
- physiological changes in pregnancy, patient factors like nutritional status, Body Mass Index (BMI), drug factors like dose, lumber puncture space [i] [ii] etc. There are very few studies that looked into the relationship of BMI and spinal hypotension. The present study aims to evaluate the correlation of hypotension according to the BMI.
Patients will be divided into two groups- Eutropia group with BMI <25 and Overweight group with BMI ≥25.
After arrival to OT, patient would be prepared for standard monitoring- NIBP, ECG, Pulse oximetry and 18G IV cannula will be given. Three readings of blood pressure will be taken 3 minutes apart and average will be taken as baseline BP. With all aseptic precautions Lumber Puncture will be done in L4-L5 intervertebral space in left lateral position using 25G Quincke’s lumbar puncture spinal needle and free flow of CSF will be noted. Then injection hyperbaric Bupivacaine [Dose:12mg] and injection Buprenorphine(60mcg) will be given slowly. Spinal sensory block height will be assessed bilaterally in mid axillary line by cold sensation using alcohol swab and motor block height will be assessed by Modified Bromage Scale. A failure will be reported if T6 sensory block not achieved after 15 mins of intrathecal injection. Co-loading of lactated Ringer’s solution will be infused for a total of 10 ml/kg until delivery. In presence of hypotension a bolus of 6 mg of Ephedrine or 100 mcg of Phenylephrine will be used whichever considered appropriate. Oxygen at a rate of 5L/min will be administered via face mask.
Blood pressure monitoring will be done every 3 mins interval until the delivery of the shoulder of the baby and volume of crystalloids infused and total doses of vasopressors will be recorded.
[i] van Bogaert LJ. Lumbar lordosis and the spread of subarachnoid hyperbaric 0.5% bupivacaine at cesarean section. Int J Gynaecol Obstet. 2000 Oct;71(1):65-6. doi: 10.1016/s0020-7292(00)00203-4. PMID: 11044545.
[ii] Hocking G, Wildsmith JA. Intrathecal drug spread. Br J Anaesth. 2004 Oct;93(4):568-78. doi: 10.1093/bja/aeh204. Epub 2004 Jun 25. PMID: 15220175
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Pregnant women between the age 18 years-45 years 2.Elective LSCS cases 3.ASA II status 4.Patients giving consent for the study 5.Singleton Pregnancy 6.Gestational age more than equals to 35 weeks.
排除标准
- •1.Patients not giving consent 2.Patients hemodynamically unstable 3.Imminent fetal or maternal health risk 4.Failed spinal 5.Patients with Hypertension, PIH, Preeclampsia, Eclampsia 6.Patients with anti-coagulants use, thrombocytopenia, bleeding disorders, history of cardiovascular diseases 7.Patients not having antenatal USG.
结局指标
主要结局
To evaluate the correlation between Body Mass Index (BMI) and incidence of episodes of hypotension following spinal anaesthesia in caesarean section
时间窗: Baseline, 0,3,6,9,12,15,18 mins
次要结局
- 1.To compare the total doses of vasopressors used in between two groups.(2.To compare the total volume of intravenous fluid used in between two groups)
研究者
Subhra Pradhan
Gauhati Medical College and Hospital