Effectiveness of Preloading Before Beach Chair Position on Patients Undergoing Arthroscopic Shoulder Surgery: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Mean arterial pressure
研究概览
简要总结
The main objective of this study is whether preloading before positioning would be effective for less hemodynamic instability. The study also analyzes that patients with preloading will decrease postoperative nausea and vomiting, better surgical satisfaction and shortened the duration of surgery and anesthesia.
详细描述
Keeping patients in normovolemic state and hemodynamically stable in anesthesia and intensive care practice are important goals of anesthesiologist. It is known that hypotension that develops after taking patients to the beach chair position has a negative effect on cerebral oxygenation. Aggressive fluid regimes using to prevent hypotension can cause glycocalyx damage, edema and organ dysfunction. Also hypertension seconday to vasopressor therapy can cause bleeding at the surgical site and impaired surgical visualization during the arthroscopic shoulder surgery.
In the literature, there are studies examine whether the hypotension is the result of decreased cardiac output or decreased systemic resistance and what should be the optimal treatment , but as far as investigators know, there is no study about effects of preloading before the beach chair position on hemodynamic parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Single-blind
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •undergoing elective arthroscopic shoulder surgery in the BCP,
- •age older than 18 years and younger than 65 years,
- •the American Society of Anesthesiologist (ASA) physical status of I or II,
- •accepting the study protocol.
排除标准
- •preoperative arrhythmia,
- •significant heart failure
- •valvular heart disease,
- •preexisting cerebrovascular disease,
- •deciding to switch to open surgery,
- •vasopressor infusion during the surgery,
- •using angiotensin converting enzyme inhibitors (ACEI) orangiotensin receptor blockers (ARB) as antihypertensive medication.
研究组 & 干预措施
Study group (preloading with crystalloid fluid - isotonic solution)
Preloading with crystalloid fluid (isotonic solution) at 10 ml/kg of ideal body weight
干预措施: Preloading with crystalloid fluid (Drug)
结局指标
主要结局
Mean arterial pressure
时间窗: during surgery (spesicific time intervals (after induction - after BCP position - 0th min - 5th min - 10th min- 30th min- 60th min)
(mmHg)
Cardiac output
时间窗: during surgery (spesicific time intervals (after induction - after BCP position - 0th min - 5th min - 10th min- 30th min- 60th min)
(L/min)
Heart rate
时间窗: during surgery (spesicific time intervals (after induction - after BCP position - 0th min - 5th min - 10th min- 30th min- 60th min)
bpm
Stroke volume variation
时间窗: during surgery (spesicific time intervals (after induction - after BCP position - 0th min - 5th min - 10th min- 30th min- 60th min)
(%) data obtained from arterial contour analysis
次要结局
- Surgical satisfaction rate(in postoperative first day)
- Ephedrine usage(during surgery)
- Total amount of crystalloid and colloid(during surgery)
- Postoperative nausea and vomiting(in postoperative first day)
- The duration of anesthesia and surgery(during surgery)
研究者
Nur Canbolat
Principal Investigator M.D.
Istanbul University