Prospective randomized comparative study of adjuvant dexmedetomidine to 0.75 percent Ropivacaine with 0.75 percent ropivacaine alone in subtenon blocks for vitreoretinal surgeries
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Effect of the adjuvant added in sub-tenons block on motor and sensory block.
研究概览
简要总结
Proposed study will be conducted on 60 patients in the age above 18yrs of either gender with ASA I-III admitted in Nethradhama Super Speciality Eye Hospital, scheduled to undergo elective Vitreoretinal surgery under subtenon blocks patients will be randomly divided into 2groups of 30 each. Group A will receive 0.75% Ropivacaine 5ml, Group B will receive 0.75% Ropivacaine with 20mcg Dexmedetomidine. Parameters to be accessed will include Motor block, sensory block, sedation level post-operative pain, surgeon satisfaction score, patient satisfaction score, concensus sleep diary. Any adverse effect will b e recorded. Follow-up visit on post-op day-1 and one week after surgery.
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
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA 1,2,3 Satisfactory akinesia following subtenon blocks and predictable surgical time of less than 3hours.
排除标准
- •Known allergy to dexmedetomidines Patients with a single eye History of sleep apnea Severe Cardiac, respiratory and renal disease Drowsy on the day of surgery with Ramsay Level of Sedation Scale Score more than 3 Normal sinus bradycardia in ECG, Baseline Hypotension recorded Dementia Communication disabilities.
结局指标
主要结局
Effect of the adjuvant added in sub-tenons block on motor and sensory block.
时间窗: 3months
次要结局
- Adverse effect associated with 20mcg Dexmedetomidine as adjuvant in subtenon block(3 months)
研究者
Dr Deepa Rakesh Sharma
Nethradhama Super Speciality Eye Hospital