CTRI/2023/04/051844尚未招募不适用
Comparative Study of Intrathecal Bupivacaine With FentanvI and Bupivacaine with Midazolam in Lower Abdominal and Lower Limb Surgeries
Dr Jayant Bhatia1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年4月30日最近更新:
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
- TO STUDY THE ONSET OF MOTOR AND SENSORY BLOCK AND DURATION OF ANALEGESIA WITH ADDITION OF MIDAZOLAM OR FENTANYL TO 0.5%BUPIVACAINE HEAVY IN SUB ARACHNOID BLOCK -baseline, 5min 10 min 15 min 20 min 30 min 45 min 60 min
研究概览
简要总结
IT IS A PROSPECTIVE COMPARATIVE RANDOMISED DOUBLE BLINDED STUDY WHERE IN INTRATHECAL BUPIVACAINE WITH FENTANYL AND INTRATHECAL BUPOVACAINE WITH MIDAZOLAM ARE COMPARED FOR ONSET QUALITY OF ANESTHESIA AND POST OPERATIVE ANALGESIA IN PATIENTS UNDERGOING LOWER ABDOMINAL AND LOWER LIMB SURGERIES
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator 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
- •ASA grade I or II fit patients Ages between 18 and 60 years Patients undergoing lower abdominal and lower limb surgeries under spinal anesthesia Haemodynamically stable patients with all routine investigations within normal limits without any other co morbidities.
- •Patients who are not on any cardiac related drugs.
- •Availability of written informed consent from concerned patient.
排除标准
- •Patients not willing to get enrolled in this study Patients with ASA physical status III or more Patients below 18 years and above 60 years of age Patients posted for emergency procedures Patients with uncontrolled systemic disorders like diabetes mellitus, heart disease, chronic hypertension, pulmonary disorders, etc Patients with spine deformities or local skin interactions overlying the lumbar vertebral region Patients with bleeding or coagulation disorders.
- •Patients with known allergies to the study drugs.
结局指标
主要结局
TO STUDY THE ONSET OF MOTOR AND SENSORY BLOCK AND DURATION OF ANALEGESIA WITH ADDITION OF MIDAZOLAM OR FENTANYL TO 0.5%BUPIVACAINE HEAVY IN SUB ARACHNOID BLOCK -baseline, 5min 10 min 15 min 20 min 30 min 45 min 60 min
时间窗: baseline, | 5min , | 10 min, | 15 min, | 20 min, | 30 min, | 45 min, | 60 min
次要结局
- TO EVALUATE QUALITY OF ANESTHESIA AND POST OPERATIVE ANALGESIA(TO MONITOR HEART RATE SP02 AT 0MIN 5 MIN 10 MIN 15 MIN 30 MIN)
研究者
研究点 (1)
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