A Comparison of the Effects of Fractionated Versus Bolus Dose of Hyperbaric Bupivacaine (0.5%) in Spinal Anaesthesia for Parturients undergoing Elective Caesarean Section: A Randomised, Double Blind Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Hemodynamic Stability in terms of Heart rate, Systolic Blood Pressure, Diastolic Blood Pressure, Mean Arterial pressure
研究概览
简要总结
PROPOSED TOPIC OF RESEARCH: “A COMPARISON OF THE EFFECTS OF FRACTIONATED VERSUS BOLUS DOSE OF HYPERBARIC BUPIVACAINE (0.5%) IN SPINAL ANAESTHESIA FOR PARTURIENTS UNDERGOING ELECTIVE CAESAREAN SECTION : A RANDOMISED, DOUBLE BLIND STUDY.â€
OBJECTIVE OF PROPOSED RESEARCH:
To compare the effects of Fractionated and Bolus dose of Hyperbaric Bupivacaine (0.5%) on maternal hemodynamics following Spinal Anaesthesia in parturients undergoing elective caesarean section.
To assess characteristics of Block and observe the Duration of Analgesia.
BACKGROUND OF PRESENT STUDY:
Bolus dose of Hyperbaric Bupivacaine in spinal Anaesthesia has rapid onset of action but may trigger Maternal hypotension leading to decreased uteroplacental perfusion whereas fractionated dose with time interval can provide Maternal hemodynamic stability with extended duration of action for parturients undergoing elective caesarean section.
METHODOLOGY:
This study is institution based, prospective, randomized study on patients undergoing Elective Caesarean section under spinal anaesthesia in Obstetric OR of MMCH. In this study a total number of 100 patients ( Pregnant mothers – ASA II ) undergoing Elective Caesarean Section will be taken & randomized equally in two groups. Group A set of patients will get single bolus dose of Hyperbaric Bupivacaine (0.5%) ; whereas the group B patients will receive Fractionated dose with half of Total calculated dose of Hyperbaric Bupivacaine (0.5%) administered initially followed by remaining half dose after 45 sec. Incidence of Hypotension & Spinal Block characteristics will be monitored & assessed. Moreover the neonatal outcome will be assessed by APGAR Score at 1 min and 5 min.
EXPECTED OUTCOME: Patients receiving Fractionated dose of Hyperbaric Bupivacaine (0.5%) are expected to experience Hemodynamic stability with less chance of Hypotension and Dense sensory & motor block with extended duration of Analgesia in comparison to those receiving Bolus dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator 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
- •Having ASA grade II .
- •Aged between 18 to 35 years.
- •Giving valid consents.
- •With singleton pregnancies undergoing Elective Caesarean Section under Spinal Anaesthesia.
排除标准
- •Parturients.
- •Not giving valid consent for Study or Spinal anaesthesia.
- •With severe cardio-respiratory disease.
- •With hepatic & renal disease.
- •With neurologic disorder or raised ICP.
- •With known endocrine disorder.
- •With psychiatric problems.
- •Having Coagulation disorder.
- •Having Spinal Deformity or Local infection at the site of injection.
- •With H/O allergy to study drugs.
结局指标
主要结局
Hemodynamic Stability in terms of Heart rate, Systolic Blood Pressure, Diastolic Blood Pressure, Mean Arterial pressure
时间窗: During surgery: Baseline, 0,2,4,6,8,10,15,20,25,30,35,40,45,50,55,60 mins (data at time of delivery will also be recorded, in this time period) | After surgery: 0.5,1,1.5,2,3,4,5,6,7,8 hr
次要结局
- Respiratory rate(During surgery: Baseline, 0,2,4,6,8,10,15,20,25,30,35,40,45,50,55,60 mins (data at time of delivery will also be recorded, in this time period))
- SpO2 %(During surgery: Baseline, 0,2,4,6,8,10,15,20,25,30,35,40,45,50,55,60 mins (data at time of delivery will also be recorded, in this time period))
- ECG, ST changes(During surgery: Baseline, 0,2,4,6,8,10,15,20,25,30,35,40,45,50,55,60 mins (data at time of delivery will also be recorded, in this time period))
- Level of sensory block and duration of sensory block(During surgery: Baseline, 0,2,4,6,8,10,15,20,25,30,35,40,45,50,55,60 mins (data at time of delivery will also be recorded, in this time period))
- Degree of motor block and duration of motor block(During surgery: Baseline, 0,2,4,6,8,10,15,20,25,30,35,40,45,50,55,60 mins (data at time of delivery will also be recorded, in this time period))
- Incidence of hypotension & Requirement of total dose of vasopressor(During surgery: Baseline, 0,2,4,6,8,10,15,20,25,30,35,40,45,50,55,60 mins (data at time of delivery will also be recorded, in this time period))
- Incidence of side effects if any(During surgery: Baseline, 0,2,4,6,8,10,15,20,25,30,35,40,45,50,55,60 mins (data at time of delivery will also be recorded, in this time period))
- Neonatal outcome by Apgar score(1 min,5 min after birth)
研究者
Dr BIJOY KUMAR BANDYOPADHYAY
Midnapore Medical College & Hospital