Comparative Study of Effects of Intrathecal Dexmeditomidine versus Fentanyl as adjuvants to Hyperbaric 0.75% Ropivacaine in Patients Undergoing Infraumbilical Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Duration of Analgesia Postoperatively-VAS (visual analogue score) VAS equal or greater than 4 or time of first Analgesia request
研究概览
简要总结
Present Study Topic: Comparative study of Effects of Intrathecal Dexmeditomidine versus Fentanyl as adjuvants to Hyperbaric 0.75% Ropivacaine in Patients Undergoing Infraumbilical Surgeries
Aims and Objectives:
Primary Objectives:To compare the duration of Analgesia in the Intrathecal Dexmeditomidine (RD) , Fentanyl (RF),Control group (RC)
Secondary Objectives: following parameters will be compared in three groups e.g time of onset , duration and quality of Sensory blockade and Motor blockade, hemodynamic changes and side effects.
Study type: Randomized comparative study
Source of data: the study will be carried out in the department of Anaesthesiology,Dr S.N.Medical College and associated hospitals(MDM hospital,MGH hospital and Ummaid Hospital Jodhpur).
Study Duration:6months or till sample size achieved.
Sample size: Total 90 Patients (30 Patients in each group)
Study population: Study population will be randomly divided by computer generated random table and group allocation will be done by shuffled closed envelope technique into three equal groups.
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Group(RF)(n=30): 2.5ml of 0.75% Hyperbaric Ropivacaine+ 25mcg Fentanyl (0.5ml)
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Group (RD)(n=30): 2.5ml of 0.75% Hyperbaric Ropivacaine+10mcg Dexmeditomidine
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Group (RC)(n=30): 2.5ml of 0.75% Hyperbaric Ropivacaine+0.5ml Normal saline
Inclusion Criteria and Exclusion criteria:as mentioned in above format.
Randomization:the each Patients will be received 3ml it the study drug according to randomization. Double blinding technique will be applied.hence the patient and the observer will be blinded to the study drug.
Intraoperatively and Postoperatively monitoring will be noted .
Statistical analysis:Data will be entered into Microsoft Excel data sheet and will be analysed using SPSS 22 version software.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult Patients of either sex ,aged between 18 and 60 years who will be Undergoing for infraumbilical surgeries Patients belonging to ASA-PS class1 and class 2 Patients without any severe comorbid diseases.
排除标准
- •Patients having any absolute contraindications for Spinal Anaesthesia such as patient not willing, raised intracranial pressure, severe hypovolemia, bleeding diathesis,local site infection,severe cardiac , respiratory,and CNS diseases are excluded from the study Pregnant females,uncontrolled diabetes and hypertension Patients with body mass index greater than 30kg/m2 Patients shorter than 150cm.
结局指标
主要结局
Duration of Analgesia Postoperatively-VAS (visual analogue score) VAS equal or greater than 4 or time of first Analgesia request
时间窗: Time in minutes-0,15,30,60,90,120,150,180,210,240,270,300
次要结局
- Secondary Objectives(Time of onset and duration of Sensory blockade)