Comparative evaluation of low dose ropivacaine with fentanyl and low dose bupivacaine with fentanyl in subarachnoid block in TURP.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- • INTRA OPERATIVE:
研究概览
简要总结
1.Aim- A comparative evaluation of low dose ropivacaine with fentanyl and low dose bupivacaine with fentanyl in subarachnoid block in transurethral resection of prostate.
2.primary objective- To compare the efficacy of low dose bupivacaine with fentanyl and low dose ropivacaine with fentanyl in terms of duration of sensory blockade.
3.secondary objective- a) to compare onset time to t10 level of sensory block in both the groups , b) to compare time to maximum sensory block level in both the groups , c) to compare time to maximum motor block level in both the groups , d) to note any hemodynamic changes or adverse effects , if any.
study area- department of anesthesia , critical care and perioperative medicine, NDMC and hindu rao hospital , delhi.
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
- 40.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Male
入选标准
- •Patients aged 40-80 years undergoing TURP.
- •Patients classified as American Society of Anesthesiologists (ASA) grade I and II.
- •Patients with a height ranging from 150 to 180 centimeters.
排除标准
- •Refusal to participate in the study.
- •Known allergy to any drugs used in the study.
- •Presence of spinal deformity or focal neurological deficits.
- •Infection at the proposed site of subarachnoid block.
- •Contraindications to subarachnoid block.
- •Coagulation disorders, inability to understand the Visual Analogue Scale (VAS), or prostate weight exceeding 70 grams.
结局指标
主要结局
• INTRA OPERATIVE:
时间窗: BLOCK characteristics(sensory and motor block) and haemodynamic parameters will be checked at-0 mins, 1 mins, 3mins, 5mins, 10mins, 15mins, 20 mins and every 10 minutes till patient is shifted to recovery room. | From arrival in PACU ( parameter to be checked are- SBP, DBP, Sensory block , Motor block , VAS score , Modified Aldrete score)- 0min, 15 min, 30 min, 45min, and every 15 min.
1.Onset Time to T10 level of sensory block.
时间窗: BLOCK characteristics(sensory and motor block) and haemodynamic parameters will be checked at-0 mins, 1 mins, 3mins, 5mins, 10mins, 15mins, 20 mins and every 10 minutes till patient is shifted to recovery room. | From arrival in PACU ( parameter to be checked are- SBP, DBP, Sensory block , Motor block , VAS score , Modified Aldrete score)- 0min, 15 min, 30 min, 45min, and every 15 min.
2.Time to maximum sensory and maximum motor block level.
时间窗: BLOCK characteristics(sensory and motor block) and haemodynamic parameters will be checked at-0 mins, 1 mins, 3mins, 5mins, 10mins, 15mins, 20 mins and every 10 minutes till patient is shifted to recovery room. | From arrival in PACU ( parameter to be checked are- SBP, DBP, Sensory block , Motor block , VAS score , Modified Aldrete score)- 0min, 15 min, 30 min, 45min, and every 15 min.
3.Total duration of sensory and motor block.
时间窗: BLOCK characteristics(sensory and motor block) and haemodynamic parameters will be checked at-0 mins, 1 mins, 3mins, 5mins, 10mins, 15mins, 20 mins and every 10 minutes till patient is shifted to recovery room. | From arrival in PACU ( parameter to be checked are- SBP, DBP, Sensory block , Motor block , VAS score , Modified Aldrete score)- 0min, 15 min, 30 min, 45min, and every 15 min.
• POST OPERATIVE:
时间窗: BLOCK characteristics(sensory and motor block) and haemodynamic parameters will be checked at-0 mins, 1 mins, 3mins, 5mins, 10mins, 15mins, 20 mins and every 10 minutes till patient is shifted to recovery room. | From arrival in PACU ( parameter to be checked are- SBP, DBP, Sensory block , Motor block , VAS score , Modified Aldrete score)- 0min, 15 min, 30 min, 45min, and every 15 min.
1. Time to first analgesic requirement will be evaluated and recorded.
时间窗: BLOCK characteristics(sensory and motor block) and haemodynamic parameters will be checked at-0 mins, 1 mins, 3mins, 5mins, 10mins, 15mins, 20 mins and every 10 minutes till patient is shifted to recovery room. | From arrival in PACU ( parameter to be checked are- SBP, DBP, Sensory block , Motor block , VAS score , Modified Aldrete score)- 0min, 15 min, 30 min, 45min, and every 15 min.
2. Regression of motor block using modified bromage score.
时间窗: BLOCK characteristics(sensory and motor block) and haemodynamic parameters will be checked at-0 mins, 1 mins, 3mins, 5mins, 10mins, 15mins, 20 mins and every 10 minutes till patient is shifted to recovery room. | From arrival in PACU ( parameter to be checked are- SBP, DBP, Sensory block , Motor block , VAS score , Modified Aldrete score)- 0min, 15 min, 30 min, 45min, and every 15 min.
3.Post operative pain (using visual analogue scale 0-10).
时间窗: BLOCK characteristics(sensory and motor block) and haemodynamic parameters will be checked at-0 mins, 1 mins, 3mins, 5mins, 10mins, 15mins, 20 mins and every 10 minutes till patient is shifted to recovery room. | From arrival in PACU ( parameter to be checked are- SBP, DBP, Sensory block , Motor block , VAS score , Modified Aldrete score)- 0min, 15 min, 30 min, 45min, and every 15 min.
4.Time to discharge(decided by the Modified Aldrete Scoring system).
时间窗: BLOCK characteristics(sensory and motor block) and haemodynamic parameters will be checked at-0 mins, 1 mins, 3mins, 5mins, 10mins, 15mins, 20 mins and every 10 minutes till patient is shifted to recovery room. | From arrival in PACU ( parameter to be checked are- SBP, DBP, Sensory block , Motor block , VAS score , Modified Aldrete score)- 0min, 15 min, 30 min, 45min, and every 15 min.
次要结局
- • SECONDARY OBJECTIVES:(1.To compare onset time to T10 level of sensory block in both the groups.)
研究者
Ajay Singh Bhardwaj
NDMC medical college and Hindu rao hospital