Comparing efficacy and safety of Intrathecal adjuvants Dexmedetomidine and Fentanyl with hyperbaric Ropivacaine in patients undergoing elective total abdominal hysterectomy surgery: A Randomized, Double-Blind, Clinical study.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- comparison of Onset and duration of sensory blockade and motor blockade provided by adjuvants Dexmedetomidine and Fentanyl, given with intrathecal Hyperbaric Ropivacaine.
研究概览
简要总结
The primary purpose of the protocol is to collect basic details of the patient, record and monitor the vital signs, fill in the information regarding the primary and secondary objectives of the study after the intrathecal drug administration. Objective of this study is to compare the effects and safety of dexmedetomidine as an intrathecal adjuvant to hyperbaric ropivacaine and fentanyl as an intrathecal adjuvant to hyperbaric ropivacaine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •patients belonging to ASA class I & class II.
- •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 infection and cardiac, respiratory, and CNS diseases.
- •Pregnant females and those with chronic diseases such as diabetes, hypertension,renal dysfunction, liver disorders and cardiac abnormalities.
- •Patients with body mass index >30 kg/m².
- •Patients shorter than 150 cm.
- •Patients allergic to any of the study drugs.
结局指标
主要结局
comparison of Onset and duration of sensory blockade and motor blockade provided by adjuvants Dexmedetomidine and Fentanyl, given with intrathecal Hyperbaric Ropivacaine.
时间窗: comparison of Onset and duration of sensory blockade and motor blockade provided by adjuvants Dexmedetomidine and Fentanyl, given with intrathecal Hyperbaric Ropivacaine at baseline,at 5 minutes, then every 15 minutes till end of the surgery, and in the postoperative period till blockade regression.
次要结局
- 1)Complete sensory & motor blockade attained & time taken for the same.(2)Total duration of analgesia.)