Does Anesthesia Induction With Target-controlled Infusion Reduce Post-induction Hypotension?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Systolic arterial pressure (SAP), measured before and after anesthesia induction was assessed to determine of post-induction hypotension in patients undergoing general anesthesia induction with TCI (target controlled infusion) or manual
研究概览
简要总结
Hemodynamic changes during induction of anesthesia may have adverse outcomes and should therefore be avoided. The decrease in blood pressure during induction of anesthesia with propofol is due to a decrease in systemic vascular resistance or cardiac output and may be increased by the concomitant use of other drugs such as remifentanil. Target controlled infusion (TCI) system aims to reach the theoretically targeted blood or brain concentration of anesthetic agents based on the patient's age, weight, and height, with computer-assisted algorithms. In manual anesthesia induction, anesthetic agents are administered at a fixed dose and rate adjusted according to the patient's weight, which may cause hypotension in patients with low cardiovascular performance. As target-controlled infusion (TCI) obviates the need to calculate the infusion rate manually, the use of TCI may provide a better hemodynamic profile during anesthesia induction This study was designed to test the hypothesis that propofol by TCI anesthesia induction is associated with a lower hypotension rate when compared with manual anesthesia induction
详细描述
Maintaining normotension is one of the top priorities for anesthesiologists due to its negative effects. Although there are a lot of studies and knowledge on the topic approximately 20-30% of patients develop post-induction hypotension. Mostly it occurs due to the adverse effects of anesthetics such as a decrease in systemic vascular resistance or cardiac output and the interplay between them. The risk can be minimized in two steps: first by identifying high-risk patients, and second with tight control of hemodynamic parameters. As a second step, tight hemodynamic control during induction may be done using target-controlled infusion (TCI) systems, which systems help to adjust the dosage to the needs of each patient by measuring hypnotic effects through the bispectral index (BIS).
TCI models for propofol have been previously compared with manual infusions, however, it is not clear whether it still contributes to or triggers hemodynamic deterioration. Therefore in this study, the investigators' aim is to determine the effect of two different anesthesia techniques on the development of postinduction hypotension through hemodynamic parameters monitored by the pressure recording analytical method (PRAM). The secondary aim is to identify risk factors that can predict postinduction hypotension
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with the American Society of Anesthesiology physical status 1-3
- •Underwent major elective surgery
- •Required intra-arterial blood pressure monitoring before induction.
排除标准
- •Under 18 years of age
- •Arrhythmia (atrial fibrillation, frequent premature beat)
- •Severe valvular heart disease
- •Morbid obesity
- •Intubation difficulty
- •Drug addiction
- •Treatment with opiates
- •Pregnancy
- •Emergency surgery
结局指标
主要结局
Systolic arterial pressure (SAP), measured before and after anesthesia induction was assessed to determine of post-induction hypotension in patients undergoing general anesthesia induction with TCI (target controlled infusion) or manual
时间窗: The duration of the study was defined from one minute before induction to 10 minutes after induction
Systolic arterial pressure (SAP- mm/Hg) was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). SAP is a parameter used to assess the pressure of the arterial system during cardiac systole
Diastolic arterial pressure (DAP), measured before and after anesthesia induction was assessed to determine of post-induction hypotension in patients undergoing general anesthesia induction with TCI (target controlled infusion) or manual
时间窗: The duration of the study was defined from one minute before induction to 10 minutes after induction
Diastolic arterial pressure (DAP, mm/Hg) was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). DAP is a parameter used to assess the pressure of the arterial system during cardiac diastole.
Mean arterial pressure (MAP), measured before and after anesthesia induction was assessed to determine of post-induction hypotension in patients undergoing general anesthesia induction with TCI (target controlled infusion) or manual
时间窗: The duration of the study was defined from one minute before induction to 10 minutes after induction
Mean arterial pressure (MAP, mm/Hg) was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). MAP is a parameter used to assess organ perfusion
次要结局
- Stroke volume variation (SVV), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia induction with TCI and manual(The duration of the study was defined from one minute before induction to 10 minutes after induction])
- Cardiac index (CI), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia induction with TCI or manual(The duration of the study was defined from one minute before induction to 10 minutes after induction)
- Arterial elastance (Ea) measured before anesthesia induction was investigated whether is a predictive parameter for post-induction hypotension in patients undergoing general anesthesia with TCI or manual(he duration of the study was defined from one minute before induction to 10 minutes after induction)
- Dp/Dt, measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia induction with TCI or manual(The duration of the study was defined from one minute before induction to 10 minutes after induction)
- Pulse pressure variation (PPV), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia induction with TCI or manual(The duration of the study was defined from one minute before induction to 10 minutes after induction)
- Cardiac power output (CPO), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia induction with TCI or manual(The duration of the study was defined from one minute before induction to 10 minutes after induction)
- Heart rate (HR), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia induction with TCI or manual(The duration of the study was defined from one minute before induction to 10 minutes after induction)