A comparative study to evaluate the efficacy between intravenous Dexmedetomidine and Magnesium sulphate for controlled hypotension during Functional Endoscopic Sinus Surgery: A randomized double blinded controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare the efficacy of Dexmedetomidine vs Magnesium sulphate in providing controlled hypotension during Functional Endoscopic Sinus Surgeries. By means of monitoring MAP mean arterial pressure throughout the procedure.
研究概览
简要总结
Endoscopic sinus surgeries are the most proposed procedure for patients with chronic Rhinosinusitis. Due to the nature of the site involved in surgery, a small amount of bleeding can cause negative effect on the procedure by affecting the proper visualization of the surgical field causing difficulty in doing surgery & prolonged duration of the surgery. So controlled hypotension will help in proper visualization of surgical field and minimize the blood loss. so we are comparing dexmedetomidine and magnesium sulphate in producing controlled hypotension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator 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-physical status I and II.
- •patients undergoing Functional Endoscopic Sinus Surgeries.
排除标准
- •Patient refusal.
- •Patients with severe cardiac hepatic renal disease.
- •Patients with a history of drug allergy to the study drugs.
- •Patients with hemodynamic instability.
- •Patients with coagulopathies.
- •Pregnant patients.
- •Patients with autonomic dysfunction.
- •Patients with Anti-arrhythmic drugs & Anti-hypertensive drugs.
结局指标
主要结局
To compare the efficacy of Dexmedetomidine vs Magnesium sulphate in providing controlled hypotension during Functional Endoscopic Sinus Surgeries. By means of monitoring MAP mean arterial pressure throughout the procedure.
时间窗: 2 hours
次要结局
- To assess the surgeons satisfaction during procedure Likert score(2 hours)
- Time to reach adequate Modified Aldrete score(20 minutes)
- To assess the level of bleeding during procedure Boezaart & Van der merwe score.
- Clinical signs related to study drugs(2 hours)
- To assess the level of sedation of the patient post operatively Ramsay Sedation Score.(2 hours)
- Time of Requirement of 1st rescue analgesia VAS score.(2 hours)