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临床试验/CTRI/2020/02/023526
CTRI/2020/02/023526尚未招募不适用

Comparison of head elevated position and Inj. Ondansetron in reducing spinal anesthesia induced hypotension in elective lower segment caesarean section: an open labeled randomized control trial

Bangalore Baptist Hospital1 个研究点 分布在 1 个国家目标入组 750 人开始时间: 2020年1月3日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
750
试验地点
1
主要终点
Fall in Blood pressure

研究概览

简要总结

Hypotension is one of the most commonimmediate complications of spinal anesthesia. Preloading with fluids is one wayof preventing hypotension. However hypotension still occurs in many patientswhich is managed by pharmacological interventions. In this study, we arecomparing three modalities which can prevent hypotension. Based on the findingsof the study, we want to standardize the care in our hospital.

There are no studies comparing theuse of head elevated position and intravenous Ondansetron in reducing spinalinduced hypotension in obstetrics. Both these interventions are simple, costeffective and carry negligible risk hence were chosen for the study.

Group H: Parturients will receivehead end elevation during and after spinal anaesthesia and will remain in thisposition till the end of the surgery. They will not receive Inj. Ondansetronprior to spinal anesthesia.

Group O; Parturients will receive Inj.Ondanstron 4 mg i.v five minutes prior to spinal anesthesia.

Group C: Parturients will neither begiven head end elevation post spinal anaesthesia nor will receive Inj.Ondansetron i.v prior to spinal anaesthesia.(standard of care)

Standard protocol for perioperativemonitoring and administration of spinal anaesthesia will be followed.

Hemodynamic parameters which include systolic, diastolic andmean arterial pressures and heart rate will be measured and recorded beforespinal anaesthesia administration, just after spinal anaesthesia, at 1 minuteintervals for the first 5 minutes, then at 5 minute intervals till the end ofsurgery.

The total dose ofephedrine required will be noted

Sensory block will be assessed using a cold swab and motor blockby modified Bromage scale every 3 minutes for 15 minutes, beyond which parturientwill be excluded if sensory block is below T6.

Time from spinalinjection to T6 sensory level, maximal sensory block level (MSBL) attained,time at which MSBL was achieved, time to skin incision, time to two segmentregression of the sensory block will be recorded.

Other side effects of spinal anesthesia like nausea, vomitingand shivering will be noted.

 APGAR at 1minute and 5 minutes will also be recorded.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
20.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Parturients for Cesarean Section.

排除标准

  • BMI >35 ASA3 Severe fetal distress Obstetric complications Medical disease complicating pregnancy Sitting position Drug volume> or< than 2 ml Contraindication to spinal anesthesia Allergy to ondansetron Parturients on medicines acting on 5HT3 Conversion to general anesthesia.

结局指标

主要结局

Fall in Blood pressure

时间窗: After spinal anesthesia at 1,2,3,4,5,10,15,20,25,30,35,40,45,50,55 and 60 minute

次要结局

  • Vomiting, maximal sensory block level, bradycardia,(After spinal anesthesia at 1,2,3,4,5,10,15,20,25,30,35,40,45,50,55 and 60 minute)

研究者

申办方类型
Private hospital/clinic

研究点 (1)

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