Comparison of the effects of Dexmedetomidine and Fentanyl as an adjuvant to 0.5% hyperbaric Levobupivacaine in lower abdominal surgeries :A randomized clinical trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 1.The onset of sensory block at T-10 level will be taken as the time from injection of anesthetic solution to the loss of sensation to pinprick.
研究概览
简要总结
THIS STUDY WILL BE CONDUCTED IN A PROSPECTIVE , RANDOMIZED , DOUBLE BLINDED AND COMPARATIVE MANNER IN A DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, MAHARAJA AGRASEN MEDICAL COLLEGE , AGROHA.
PRIMARY OBJECTIVES OF THE STUDY WILL BE;
TO ESTIMATE ONSET OF SENSORY AND MOTOR BLOCK.
TO ESTIMATE DURATION OF SENSORY AND MOTOR BLOCK.
SECONDARY OBJECTIVES OF THE STUDY WILL BE;
TO ESTIMATE ANY HEMODYNAMIC CHANGES.
TO ESTIMATE SIDE EFFECTS IF ANY.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor 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
- •AMERICAN SOCIETY OF ANAESTHESIOLOGIST(ASA) PHYSICAL STATUS CLASS 1 AND 2.
排除标准
- •Patient’s refusal.
- •Patient having Bleeding disorders.
- •Patient having Neurological disease.
- •Patient having Local skin infections at the site of spinal block.
- •Patient having Severe back deformities.
- •Patient having Raised intracranial pressure.
- •Patient having Cardiac and respiratory disease.
- •Patient of Morbid obesity.
- •Patient having allergy to study drugs.
结局指标
主要结局
1.The onset of sensory block at T-10 level will be taken as the time from injection of anesthetic solution to the loss of sensation to pinprick.
时间窗: After the block, vitals will be monitored 2, 5, 10, 15, 20 and 30 min and thereafter, every 10 min interval till 90 minutes and 30 min intervals thereafter.
2.Duration will be taken as from time of onset to time at which patient feel sensation to pinprick at T-10.
时间窗: After the block, vitals will be monitored 2, 5, 10, 15, 20 and 30 min and thereafter, every 10 min interval till 90 minutes and 30 min intervals thereafter.
3.Onset time of motor block will be taken as the time to acquire complete motor block after the intrathecal injection of local anesthetic.
时间窗: After the block, vitals will be monitored 2, 5, 10, 15, 20 and 30 min and thereafter, every 10 min interval till 90 minutes and 30 min intervals thereafter.
4.Total duration will be taken as time from onset to completely recover from the motor block.
时间窗: After the block, vitals will be monitored 2, 5, 10, 15, 20 and 30 min and thereafter, every 10 min interval till 90 minutes and 30 min intervals thereafter.
次要结局
- HYPOTENSION(BRADYCARDIA)
研究者
Dr Varsha Jangra
Maharaja Agrasen Medical College,Agroha,District Hisar