Evaluation of the intra operative use of balanced salt solution versus lactated ringers solution on postoperative arterial blood gas analysis and renal function indicators in patients with primary hypertension treated with angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) in elective surgeries under general anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To compare serum potassium and eGFR in the immediate postoperative period in both the groups with baseline
研究概览
简要总结
Antihypertensive medications which act on the Renin-angiotensin system by inhibition of the angiotensin converting enzyme (ACEi) or by blocking the angiotensin-2 receptors (ARB) are very commonly used in management of essential hypertension. As a common protocol, these medications are withheld 24 hours before an elective surgery, primarily to avoid intraoperative hypotensive episodes. Regardless of their preoperative withdrawal one day prior to surgery, these medications are likely to increase the risk of postoperative acute kidney injury. Lactated Ringer’s solution is one of the most used intravenous fluid inside the operating room. Excess lactate in RL thus, reduces strong ion difference and can potentially cause metabolic acidosis. A rise in lactic acidosis or hyperkalemia can further reduce renal perfusion and increase the possibility of AKI. Balanced salt solutions present as a better alternative in such situations as they are iso-osmolar (294mosm/l) and have a pH of around 7.4. Hence, this study aims to compare the effect of balanced salt solution with lactated ringer’s solution on postoperative serum potassium levels, estimated GFR, serum lactates, serum pH and chloride levels in patients with essential hypertension treated preoperatively with angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) posted for elective surgeries under general anaesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant 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 1 and 2 Age 18-60 years Both genders Elective surgeries under general anaesthesia of not more than 240 mins in duration Known case of essential hypertension since more than 2months on angiotensin convertase inhibitor or angiotensin receptor blocker medication.
排除标准
- •ASA grade 3and 4 Patients on diuretics Patients on beta blockers Patients on non-steroidal analgesics Patients with congestive heart failure Patients with renal artery stenosis Patients with atherosclerosis, thrombosclerosis Patients with excessive preoperative fluid deficit due to gastrointestinal fluid loss.
结局指标
主要结局
To compare serum potassium and eGFR in the immediate postoperative period in both the groups with baseline
时间窗: Serum potassium and eGFR within 1 hour and after 24 hours after extubation
次要结局
- To compare serum pH and standard base excess on arterial blood gas analysis in the immediate postoperative period in both the groups(Serum pH and standard base excess measurement at baseline, within in 1 hour and 24 hours after extubation)
- To compare serum lactate levels in the plasmalyte group with those in the Ringer’s Lactate group at different time intervals with baseline(Serum lactate levels within 1 hour and 24 hours after extubation)
- To compare postoperative serum chloride levels on arterial blood gas analysis in the immediate postoperative period in both the groups With baseline(Serum chloride levels within in 1 hour and after 24 hours of extubation)
- To compare perioperative urine output in both the groups.(24 hours urine output after extubation)
研究者
Dr Nishanth M
Nizams institute of medical sciences