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临床试验/CTRI/2024/08/072089
CTRI/2024/08/072089尚未招募不适用

Efficacy of level adjusted local anaesthetic dose for subarachnoid block in elective caesarean section -A randomised trial.

Mahatma Gandhi Medical College1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年8月26日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
300
试验地点
1
主要终点
To estimate the incidence of hypotension following subarachnoid block with three different doses of bupivacaine at three different levels.

研究概览

简要总结

All parturients  of category IV will be  pre-medicated with tablet pantoprazole 40mg and  tablet perinorm 10mg night before and morning of surgery. Parturients belonging to category III will receive oral pantoprazole 40 mg two hours prior to surgery. A 18 gauge intravenous cannula will be inserted and standard monitoring such as non-invasive blood pressure ,saturation and ecg will be established. The base line vitals will be recorded. The patient will then be placed in lateral position. Pre-procedural ultrasound scanning will be done to identify the respective interspace. Then subarachnoid blockade will be administered using 25 g quincke’s needle in group A with 2ml of 0.5% hyperbaric bupivacaine in L2-L3 space , group B with 2.2ml of 0.5%bupivacaine in L3-L4 space, in group C 2.4ml of 0.5%bupivacaine in L4-L5 space. Drug will be loaded in 2.5ml syringe and will be administered at the rate of 0.2ml/sec. All the patients will be coloaded with intravenous crystalloids at 15ml/kg after the administration of intrathecal bupivacaine. Then patient will be placed in supine position. Wedge will be placed for all patients. Supplemental oxygen will be given with face mask at 6l/min. Sensory block assessment will be done with pinprick method and motor assessment will be done by bromage assessment. Desired spinal level is T4-T6. Manoeuvres required to achieve the spinal level such at head down(Trendelenburg position) will be noted. Time taken to achieve the desired level will also be noted. Hemodynamic parameters will be measured at 0,1,2 minutes  and  there after every 2 minutes for the first 15minutes. Then after every 5minutes till the end of surgery. 0 minute is defined  as the time of removal of spinal needle. Surgery will be proceeded and after the delivery of the baby 20 international units of oxytocin intravenously will be administered. Delivery time , weight and apgar score of the baby will be noted. Hypotension is defined as 20% decrease in blood pressure from the baseline or systolic blood pressure less than 90mmhg. Bradycardia is defined as 20% decrease in heart rate from baseline or less than 50 beats/minute. Hypotension will be treated with intravenous ephedrine 6mg bolus dose and total dose required will be noted. Bradycardia will be treated with intravenous atropine 0.6mg and will be noted. Incidence of dizziness, nausea and vomiting due to maternal hypotension will also be noted. At the end of surgery blood loss and total intravenous crystalloids used will be noted. All patients will receive 2 mcg/kg of intravenous fentanyl after the delivery of the baby and intravenous paracetamol1g during skin closure. Patients who require more than three attempts for spinal anaesthesia and patients with insufficient sensory blockade at the end of 10mins, general anaesthesia will be administered and patients will be excluded from the study.By using the ultrasound ,the space cannot be identified,then the patient will be excluded from the study.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • 1.Term pregnancy (37 weeks) 2.Category IV.
  • Planned for elective LSCS 3.Category III.
  • Needing early delivery but no fetal or maternal compromise 4.Height more than 150 cms 5.ASA II 6.Singleton pregnancy.

排除标准

  • 1.Hypertensive disorder complicating pregnancy 2.Cardiovascular illness 3.Fetal abnormalities 4.Height more than 180 cms 5.BMI more than 35 6.Other contraindications for spinal anaesthesia.

结局指标

主要结局

To estimate the incidence of hypotension following subarachnoid block with three different doses of bupivacaine at three different levels.

时间窗: At 1,2,4,6,8,10,12,15,20,25,30,35,40,60,90 minutes following subarachnoid block

次要结局

  • To estimate the spinal level achieved, time to achieve the level, total vasopressor required.(At 1,2,4,6,8,10,12,15,20,25,30,35,40,60,90 minutes following subarachnoid block)

研究者

发起方
Mahatma Gandhi Medical College
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Balaji Chenthil

SBV Deemed to be university

研究点 (1)

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