Effect of low dose versus conventional dose intrathecal fentanyl with hyperbaric bupivacaine on the block characteristics in parturient undergoing caesarean section under spinal anaesthesia : a randomised controlled study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Duration of analgesia [Time (minutes) to demand of first rescue analgesic assessed by visual analogue scale]
研究概览
简要总结
The study is a prospective randomizeddouble-blinded trial to assess and compare the effects of intrathecaladministration of low dose 12.5µgm and conventional25µgm fentanyl citrate with 0.5% bupivacaine (2 ml, heavy) in parturientundergoing LSCS procedures under subarachnoid block which will be conducted in the Department of Anaesthesiology, regional Institute of Medical Sciences, Imphal, Manipur. Atotal of 60 parturient will be selected for the study and divided into 2 groupsof 30 patients each viz. Group A (n-30) and Group B (n-30) .According to a computer generated randomizationtable, patients in group A will be administered 2 ml of 0.5% bupivacaine heavyplus 0.5ml (12.5µgm) fentanyl citrateand group B willbe administered 2 ml of 0.5% bupivacaine heavy plus 0.5ml (25 µgm) fentanyl citrate in the subarachnoid spaceL3-L4 In both the groups,the study drugs will be administered at a rate of 0.2 ml/min. in thesubarachnoid space L3-L4. The time to first rescue analgesia, blockcharacteristics along with regression of the blockade, side effects (if any)and the hemodynamic changes will be observed, assessed and recorded by blindedinvestigator using the VAS, sedation scale, modified Bromage scale.The data collected will be collected and analysedusing Student‘t’ test for continuousdata and Chi-square test for categorical data as and where appropriate.
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 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •(ASA) physical status I or II undergoing lower segment caesarean section under spinal anaesthesia.
排除标准
- •1.History of allergy to study drugs 2.Bleeding disorder-platelet count <50,000/micro litre, prothrombin time>14sec,International normalised ratio(INR)->1.5 3.Local site infection 4.Cardiac, respiratory diseases and kidney disorder, neurological deficit 5.Spinal deformity.
结局指标
主要结局
Duration of analgesia [Time (minutes) to demand of first rescue analgesic assessed by visual analogue scale]
时间窗: From time of intrathecal injection (baseline) to the time when patient first demands rescue analgesia (minutes)
次要结局
- 1.Hemodynamic profile- pulse rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), Oxygen saturation (SpO2)(2.Time of sensory block at onset T 10(secs))