A Comparison of Intrathecal Clonidine versus Dexmedetomidine versus 0.9% Saline as Adjuvants to 0.5% Hyperbaric Bupivacaine in Elective Gynecological Surgery.
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
- 1
- 主要终点
- To compare the effect and adverse effect of intrathecal Clonidine versus Dexmedetomidine versus 0.9% Saline as adjuvants to 0.5% Hyperbaric Bupivacaine in subarachnoid block in patients undergoing elective gynaecological surgeries by using the following parameters:
研究概览
简要总结
| Spinal anaesthesia will be performed at the level of L3-L4 through a midline approach using a 25-gauge Quincke spinal needle with patient in lateral position. After confirming free flow of cerebrospinal fluid, drug is injected into subarachnoid space. |
Patients will be divided into three groups of thirty each (n=30):-
Group BC ,Group BD and Group BS.
Group-BC: 0.5% bupivacaine 17.5mg (3.5ml) with 50µg Clonidine (in 0.5ml normal saline) (Total volume-4ml) .
Group-BD: 0.5% bupivacaine 17.5mg (3.5ml) with 5 µg Dexmedetomidine
(in 0.5ml normal saline) (Total volume-4ml).
Group-BS:0.5% Bupivacaine 17.5mg (3.5ml) with 0.9% Normal saline (0.5ml)
(Total volume-4 ml).
The time to reach T6 dermatome sensory block will berecorded before surgery.Visual Analog Scale will be recorded up to 24 hoursto assess adequacy of analgesia
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Patients who are posted for elective gynecological surgeries.
- •2.Age group 18-60 years.
- •3.American Society of Anesthesiologists (ASA) grades I and II.
- •4.Patients with Body Mass Index (BMI) between 18.5-24.
- •5.Patients with height ranging between 150 cm and 180 cm .
- •6.Patients who are willing to participate in the study with informed consent.
排除标准
- •1.Patients taking alpha-adrenergic receptor antagonists, calcium channel blockers and angiotensin converting enzyme inhibitors 2.Patients having any absolute contraindications for spinal anaesthesia like increased intracranial tension, severe hypovolemia, history of bleeding diathesis and local infection.
结局指标
主要结局
To compare the effect and adverse effect of intrathecal Clonidine versus Dexmedetomidine versus 0.9% Saline as adjuvants to 0.5% Hyperbaric Bupivacaine in subarachnoid block in patients undergoing elective gynaecological surgeries by using the following parameters:
时间窗: BASAL , 2 MIN , 5 MIN , 10 MIN , 20 MIN , 30 MIN , 40 MIN , 50 MIN , 60 MIN , 70 MIN , 80 MIN , 90 MIN , 120 MIN , 140 MIN , 160 MIN , 180 MIN
1. Duration of analgesia.
时间窗: BASAL , 2 MIN , 5 MIN , 10 MIN , 20 MIN , 30 MIN , 40 MIN , 50 MIN , 60 MIN , 70 MIN , 80 MIN , 90 MIN , 120 MIN , 140 MIN , 160 MIN , 180 MIN
2. To assess the onset and duration of motor block.
时间窗: BASAL , 2 MIN , 5 MIN , 10 MIN , 20 MIN , 30 MIN , 40 MIN , 50 MIN , 60 MIN , 70 MIN , 80 MIN , 90 MIN , 120 MIN , 140 MIN , 160 MIN , 180 MIN
次要结局
- Peri-operative hemodynamic changes and adverse effects(2 HOURS , 8 HOURS , 12 HOURS , 24 HOURS)