Effect of adding fentanyl vs dexmedetomidine in subarachnoid block characteristics with low dose isobaric levobupivacaine 0.5% in below umbilical surgeries A Randomized control trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Self
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To assess the effect of Dexmedetomidine and fentanyl in terms of
研究概览
简要总结
Spinal anaesthesia is a preferred technique for infraumbilical surgeries due to rapid onset dense neural blockade and effective postoperative analgesia
However using low dose local anaesthetic agents may reduce side effects but can limit block duration and quality. The addition of intrathecal adjuvants such as fentanyl and dexmedetomidine has been shown to enhance the quality and duration of spinal block .This randomized controlled double-blind study aims to compare the effects of adding fentanyl versus dexmedetomidine to low-dose (0.5%) isobaric levobupivacaine in patients undergoing elective infra-umbilical surgeries under spinal anaesthesia. A total of 80 adult patients ASA I–II aged 18–60 years will be randomly allocated into two equal groups.
Group D will receive 1.5 mL of 0.5% isobaric levobupivacaine with 5 µg dexmedetomidine, and Group F will receive 1.5 mL of 0.5% isobaric levobupivacaine with 25 µg fentanyl intrathecally. Block characteristics onset and duration of sensory and motor blockade duration of postoperative analgesia and hemodynamic changes will be recorded. Adverse effects such as bradycardia hypotension nausea vomiting pruritus and drowsiness will also be monitored.
The expected outcome is to determine which adjuvant fentanyl or dexmedetomidine provides better spinal block characteristics prolonged postoperative analgesia and stable hemodynamic profile when combined with low dose isobaric levobupivacaine for below umbilical surgeries.
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, 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
- •ASA grade I or II Elective infraumbilical surgeries under spinal anesthesia Written informed consent obtained.
排除标准
- •Patient refusal Known allergy to study drugs Patients using alpha 2adrenergic receptors antagonists calcium channel blockers angiotensin converting enzyme inhibitor Local infection at the injection site Sepsis and Septic shock.
结局指标
主要结局
To assess the effect of Dexmedetomidine and fentanyl in terms of
时间窗: During intraoperative period the | Heart Rate Blood Pressure SpO2 | Monitored | Every 3 Minutes for 30 Minutes | Then Every 5 Minutes for 1 hours | than every 15 minutes for next | hours Until Surgery Completed
1 Hemodynamic parameters heart rate HR systolic blood pressure SBP diastolic blood pressure DBP mean arterial
时间窗: During intraoperative period the | Heart Rate Blood Pressure SpO2 | Monitored | Every 3 Minutes for 30 Minutes | Then Every 5 Minutes for 1 hours | than every 15 minutes for next | hours Until Surgery Completed
pressure MAP
时间窗: During intraoperative period the | Heart Rate Blood Pressure SpO2 | Monitored | Every 3 Minutes for 30 Minutes | Then Every 5 Minutes for 1 hours | than every 15 minutes for next | hours Until Surgery Completed
2 Oxygen saturation SpO2
时间窗: During intraoperative period the | Heart Rate Blood Pressure SpO2 | Monitored | Every 3 Minutes for 30 Minutes | Then Every 5 Minutes for 1 hours | than every 15 minutes for next | hours Until Surgery Completed
次要结局
- Time from spinal injection to first request for rescue analgesia(Adverse effects such as bradycardia low blood pressure nausea vomiting itching drowsiness and respiratory depression were observed and treated as needed)
研究者
Dr Ishika garg
Rohilkhand medical college and hospital