Prophylactic fixed-rate phenylephrine versus norepinephrine infusion for the prevention of post-spinal anesthesia hypotension during lower abdomen surgeries a prospective double blinded randomised controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- To compare the efficacy and safety profile of pre emptive phenylephrine vs noradrenalinefor prevention of hypotension during spinal anesthesia in lower abdominal surgery
研究概览
简要总结
Nowadays spinal anesthesia is widely used for elective lower abdominal surgeries. It is frequently accompanied by hypotension, which may be defined in absolute terms as a systolic blood pressure (SBP) less than 90 or 100 mmHg or in relative terms as a percentage (20% fall from baseline).[1] The severity of this hypotension depends on the height of the block, the position of the patient, and the volume status of them.But the chance of most serious complication such as postspinal hypotension is a major limitation of this technique.The incidence of hypotension can be as high as 70%–80% when pharmacological prophylaxis is not used.
Hypotension following spinal anesthesia is common and can be actively countered by the use of vasopressors. Prophylactic infusion of vasopressors with a rescue bolus dosing was observed to be more effective for hemodynamic stability when compared to administering a bolus dose alone. In this study, we plan to :
-
Compare prophylactic fixed-rate intravenous infusions of phenylephrine and norepinephrine during lower abdominal surgeries under spinal anesthesia
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Compare the requirement of intraoperative provider-administered rescue bolus of mephentermine needed to overcome post-spinal anesthesia hypotension.
This study will conducted at the department of anesthesiology All India Institute of medical sciences Gorakhpur Uttar Pradesh India.This tertiary care hospital is equipped with advanced medical facilities and high volume of surgery cases.The setting ensures diverse access to patient population undergoing elective lower abdominal surgery.This study is a randomised,controlled, double blinded, parallel assignment, single centre designed to compare the efficacy of fixed rate prophylatic phenylephrine vs noradrenaline in prevention of post spinal hypotension in lower abdominal surgery.Inclusion and exclusion criterias will be followed.Randomisation will be computor based and with total sample size of 180 patients.
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
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA 1 and 2 patients.
排除标准
- •Patient’s refusal Infection at the site Coagulation abnormalities Allergy to the study drug(s) Repeat spinal or failed spinal Pregnant females Known case of hypertension Heart rate increased or decreased 20% from baseline Cardio Vascular diseases Sensory loss above T6 level.
结局指标
主要结局
To compare the efficacy and safety profile of pre emptive phenylephrine vs noradrenalinefor prevention of hypotension during spinal anesthesia in lower abdominal surgery
时间窗: Prophylatic infusion is given 10 min prior to spinal and monitoring ( BP, Saturation,heart rate and mean arterial pressure)is done for every 3 min for first 30 min and then every 5 min until completion of surgery
次要结局
- To study hemodynamic stability between both drugs(Use of mephentermine (rescue bolus) requirement)
研究者
SYED FAZIL A
ALL INDIA INSTITUTE OF MEDICAL SCIENCE GORAKHPUR