EFFICACY OF INTRATHECAL 0.5% HYBERBARIC BUPIVACAINE 5mg WITH FENTANYL 10mcg VERSUS 0.5% HYPERBARIC BUPIVACAINE 5mg WITH FENTANYL 20mcg ON QUALITY OF ANAESTHESIA AND HEMODYNAMIC PARAMETERS IN PARTURIENTS UNDERGOING CESAREAN SECTION: A RANDOMISED STUDY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- QUALITY OF ANASTHESIA - LEVEL AND DEPTH OF SENSORY AND MOTOR BLOCKADE
研究概览
简要总结
Regional Anaesthesia is the preferredtechnique during Lower Segment Cesarean Section. Bupivacaine is the mostcommonly used local anaesthetic agent in spinal anaesthesia. Opioidssuch as fentanyl are commonly used as intrathecal adjuvants to improve thequality of intraoperative analgesia and prolonged post-operativeanalgesia.
The rapid onset of sympatheticblockade and subsequent hypotension remains a major clinicalconcern. Hypotension leads to nausea, vomiting and neonatal morbidity byreducing uteroplacental blood flow. Lowering the dose of intrathecalbupivacaine by using fentanyl as adjuvant can be used to maintain betterhemodynamic stability, lesser requirement of vasopressors, provide betteranalgesia, reduced Post-Operative Nausea and Vomiting.
This study is undertaken to study theeffect of Hyperbaric Bupivacaine 0.5% 5mg with fentanyl 10mcg vs of HyperbaricBupivacaine 0.5% 5mg with fentanyl 20mcg in spinal anaesthesia on hemodynamicchanges, onset, level, duration and speed of regression of Sensory andMotor blockade in Parturients undergoing Lower Segment Caesarean Section.
Our study is Randomised Controlledstudy which will be conducted in Bangalore Medical College And ResearchInstitute, Bangalore. It will be conducted on 100 participants, 50in Hyperbaric Bupivacaine 0.5% 5mg with fentanyl 10mcg group and 50in Hyperbaric Bupivacaine 0.5% 5mg with fentanyl 20mcg.
Intraoperatively Hemodynamic variablesand level and depth of anaesthesia will be recorded every minute for first fiveminutes, at 5 minutes for next half an hour after the administration ofsubarachnoid block and every 10 minutes thereafter up to 120 minutes after theblock. Postoperatively patient will be monitored every 1hr for the first4hours. Side effects such as hypotension, bradycardia, shivering, nausea,vomiting, pruritis, respiratory depression and ECG changes will berecorded and accordingly managed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
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 CLASS II, AGED BETWEEN 18 TO 40 YEARS, POSTED FOR ELECTIVE CESAREAN SECTION.
排除标准
- •PATIENTS REFUSAL ALLERGIC TO DRUG OBESE ASA CLASS III OR IV PRE ECLAMPSIA, ECLAMPSIA, CARDIAC OR RESPIRATORY INSUFFICIENCY, TWIN GESTATION SEVERE FETAL DISTRESS, PLACENTAL ABRUPTION, PLACENTA PREVIA, CORD PROLAPSE CONTRAINDICATIONS FOR NEURAXIAL BLOCKADE.
结局指标
主要结局
QUALITY OF ANASTHESIA - LEVEL AND DEPTH OF SENSORY AND MOTOR BLOCKADE
时间窗: BASELINE READING AND 1MIN AFTER SAB, 2MIN, 3MIN, 5MIN, 10MIN, 15MIN, 20MIN, 25MIN, 30MIN, 40MIN,50MIN, 60MIN, 75MIN, 90MIN, 105MIN, 120MIN, POSTOPERATIVELY HOURLY FOR 4 HOURS
次要结局
- NO HEMODYNAMIC CHANGES OR SIDE EFFECTS(BASELINE READING AND 1MIN AFTER SAB, 2MIN, 3MIN, 5MIN, 10MIN, 15MIN, 20MIN, 25MIN, 30MIN, 40MIN,50MIN, 60MIN, 75MIN, 90MIN, 105MIN, 120MIN, POSTOPERATIVELY HOURLY FOR 4 HOURS)