A clinical comparative study of bupivacaine with dexmedetomidine and ropivacaine with dexmedetomidine as an adjuvant in thoracic epidural for patients undergoing abdominal surgeries for post operative pain management
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Post operative analgesia with duration of analgesia
研究概览
简要总结
A CLINICAL COMPARATIVE STUDY OF BUPIVACAINE WITH DEXMEDETOMIDINE AND ROPIVACAINE WITH DEXMEDETOMIDINE AS AN ADJUVANT IN THORACIC EPIDURAL FOR PATIENTS UNDERGOING ABDOMINAL SURGERIES FOR POST OPERATIVE PAIN MANAGEMENT.
PRIMARY OBJECTIVE: To compare the efficacy and safety profile of ropivacaine 0.75% 20 ml and bupivacaine 0.5% 20 ml with dexmedetomidine 1 mcg/kg given via epidural route in the patients planned for abdominal surgery.
SECONDARY OBJECTIVE :
-
Hemodynamic alteration
-
Intraoperative complications
3.Postoperative complications
-
Duration of analgesia
-
Quality of analgesia
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
- 25.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA physical status 1 & 2 patients.
排除标准
- •EXCLUSION CRITERIA:
- •Age less than 25 years and more than 60 years.
- •Unwilling patients not giving consent for operation.
- •ASA physical status class III or more.
- •Patients having known hypersensitivity to amide local anaesthetics and Dexmedetomidine.
- •Patients displaying sign and symptoms of systemic infection.
- •6.Patients having local infection in thoracic spinal region.
- •Patients with pre-existing Diabetes Mellitus, Hypertension, Ischaemic Heart Disease, COPD or any other major systemic illness.
- •Pre-existing CNS disorder-Epilepsy and raised intracranial tension.
- •Pre-existing respiratory disorder-COPD, Asthma, Chronic Bronchitis.
- •Severe renal, hepatic, cardiological, haematological, metabolic disorder.
- •Cardiovascular malformation.
- •Bleeding diathesis or coagulopathy.
- •Spinal deformity.
- •Patients on anticoagulant or antiplatelet therapy.
结局指标
主要结局
Post operative analgesia with duration of analgesia
时间窗: From the time of insertion of epidural and drug given till the time patient starts complaining pain
次要结局
未报告次要终点
研究者
Dr Pramod Chand
LLRM Medical College