Comparative Evaluation of Intrathecal Bupivacaine-fentanyl and Bupivacaine-dexmedetomidine for Elective Low Segment Caesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Time of maximum bromage achieved (Sec)
研究概览
简要总结
the primary objective of the study is to compare the onset and recovery times of sensory and motor blockade of the two study drugs intrathecally with low dose bupivacaine The secondary objectives of the study are to observe hemodynamics, side effects profile, and duration of postoperative analgesia
详细描述
The current study is undertaken to compare the effect of two drugs intrathecally.edexmedetomidine and fentanyl with a low dose of bupivacaine and assess the adequacy of the block, side effect profile and postoperative analgesia. The two drugs have been studied separately but the comparative data is scarcely available both at national and international level. A particular agent is a dexmedetomidine that has been introduced in the investiagator's setup for the first time so this research will be of great importance in adding its multiple uses other than being used as ICU and procedural sedation agent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
盲法说明
Patients were randomly allocated into two groups and will be blinded to the study drugs. The drugs will be chosen by seal envelope method by principal investigator and co-investigator. The drugs will be filled in the syringes and the syringes handed over to on floor consultant anesthetist who are blinded to the study.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Term pregnancy Singleton ASA I and II, BMI <35, elective C/section
排除标准
- •patient refusal, contraindications to spinal anaesthesia. ASA III and IV, PIH Pre Eclampsia, allergic to Local Anesthetic, fetal anomalies.
研究组 & 干预措施
Group BF
hyperbaric Bupivacaine 10mg with fentanyl 10micrograms
干预措施: Bupivacaine, fentanyl (Drug)
Group BD
hyperbaric Bupivacaine 10 mg with dexmedetomidine5 micrograms
干预措施: Bupivacaine, dexmedetomidine (Drug)
结局指标
主要结局
Time of maximum bromage achieved (Sec)
时间窗: Post operative initial hour
Spinal block characteristics
Time till T10 dermatome achieved (Sec)
时间窗: Post operative initial hour
Spinal block characteristics
Regression time to T10 dermatome (Min)
时间窗: Post operative initial hour
Spinal block characteristics
Time of complete motor recovery (Min)
时间窗: Post operative initial hour
Spinal block characteristics
Post-operative pain score
时间窗: 4 hour
VAS score indicate 0 no pain 10 severe pain. Pain score was noted down
次要结局
- Hypotension(24 hours Post operative)
- Nausea(24 hours Post operative)
- Pruritus(24 hours Post operative)
- Vomiting(24 hours Post operative)
- Bradycardia(24 hours Post operative)
- Respiratory distress(24 hours Post operative)
- Shivering(24 hours Post operative)
研究者
Sana Urooj
Assistant Professor
Dow University of Health Sciences