"The Role of 6% Hydroxyethyl starch and Ringers lactate for preloading in patients undergoing elective caesarean section under spinal anaesthesia - A Prospective randomised clinical study "
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To compare the incidence of hypotension while using 6% HES or Ringers lactate for preloading who are undergoing elective caesarean section under spinal anaesthesia.
研究概览
简要总结
Patients will be checked for NBM status of minimum 8hrs.
After thorough pre anesthesia checkup all the patients sufficing the inclusion criteria will be selected ,procedure of spinal anaesthesia and purpose of the study will be explained and informed written consent will be taken.
TROLLEY PREPARATION:Cylinders and circuits to be checked ,multipara monitor, airway equipment,L P tray (consisting of 23G ,2cc syringe,needle,wound towel,cotton swabs ,gauze pieces) and drugs required for spinal anesthesia to be kept ready for induction.
After taking patient inside the operation theatre , a wedge will be put on the right side and oxygen will be given through facemask, intravenous access will be secured with 18G IV cannula, multipara monitor will be attached and baseline vital parameters (Pulse,SBP,DBP,MAP) and Spo2 will be noted.
PRE MEDICATIONS:
Inj Glycopyrrolate 5ug/kg IV
Inj Rantac 50mg IV
Inj Ondansetron 0.1mg/kg IV
GROUPING OF PATIENTS:
Patients will be divided in to 2 groups with the help of randomistaion (using sealed envelope method).
GROUP1: Preloading with 500ml of 6% HES 20mins before induction.
GROUP2:Preloading with 1000ml of Ringers lactate 20mins before induction.
ANESTHESIA TECHNIQUE:
Patient will be put into the left lateral position and under all aseptic precautions spinal anesthesia will be performed at L2-3 or L3-4 interspaces .The skin will be infiltrated with 2ml of 2 percent local anesthesia(lignocaine)and then using a 23 gauuge Quincke needle pointing cephalad all patients in the study will recieve 2cc (10mg) of 0.5% Injection Bupivacaine heavy .After giving spinal anesthesia patient will be positioned supine ,oxygen @5L/min will be adminstered by using facemask.
MONITORING AND OBSERVATIONS :
SPINAL BLOCKADE ASSESMENT:
Surgery will be commenced once the level of sensory blockade is T6 dermatomal level by pinprick method and motor blockade is grade 3 according to Bromage scale.
HAEMODYNAMIC ,SPO2 AND UOP MONITORING:
Baseline haemodynamic parameters (pulse rate,SBP.DBP,MAP),SPO2 and UOP will be measured and then monitoring will be done after preloading ,after giving spinal anesthesia at 1,3,5,7,10.15.20 mins and at 5mins intervals of both the groups till the end of surgery .
Patients who develop hypotension (fall in blood pressure >20% from the baseline) will be treated with IV Boluses of 5mg Ephedrine , additional doses of ephedrine will be repeated if hypotension persists ,and the requirements will be noted throughout the intra operative period .Other side effects like bradycardia (HR Less than 20% of baseline) and allergic reactions will be treated with Inj Atropine 0.6mg IV and Inj AVIL +Inj DEXONA respectively if required.
If patients are having any allergic reactions to HES it will be noted ,and our study will be discontinued .If patients are getting to converted to General anesthesia they will be excluded from study .
Following the delivery,the neonatal outcome will be maesured by APGAR SCORE at 1st and 5th minute of delivery .Patients will be monitored postoperatively every 2hrly till 24hrs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •ASA I AND II.
排除标准
- •Unwillingness of the patient.
- •BMI >25kg/meter square, Height less than 152cms.
- •Patients with Multiple gestation.
- •Patients with spine deformity,previous history of spine surgeries.
- •Severe anemia,coagulation abnormalities and bleeding disorders.
- •Patients with active skin lesions over lumbosacral region.
- •Medical disorders like chronic hypertension,diabetes,liver disease,renal diseases(calculi,stenosis,altered renal function tests), and CVS abnormalities(MI,Heart blocks etc).
结局指标
主要结局
To compare the incidence of hypotension while using 6% HES or Ringers lactate for preloading who are undergoing elective caesarean section under spinal anaesthesia.
时间窗: To compare the incidence of hypotension while using 6% HES or Ringers lactate for preloading who are undergoing elective caesarean section under spinal anaesthesia. | Patient will be monitored upto 24hrs after surgey
次要结局
- To compare the requirement of ephedrine to treat hypotension when preloaded with 6%HES or ringers lactate.(To assess the neonatal outcome in both the groups.)