Risk Factors for Post-Induction Hypotension Following General Anesthesia in Geriatric Patients Undergoing Elective Non-Cardiac Surgery : A Prospective Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Association Between Pre-Induction Risk Factors and Post-Induction Hypotension
研究概览
简要总结
The purpose of this study is to identify risk factors contributing to post-induction hypotension in geriatric patients undergoing elective non-cardiac surgery under general anesthesia at Dr. Cipto Mangunkusumo National Central Public Hospital. Post-induction hypotension is defined as a decrease in Mean Arterial Pressure (MAP) of more than 30% from baseline after anesthesia induction up to 20 minutes post-induction. This condition can lead to adverse effects such as myocardial injury, acute kidney injury, stroke, and even death.
This research aims to answer several key questions, including whether the following factors influence the risk of post-induction hypotension:
- Airway management with endotracheal intubation.
- Low albumin levels.
- Presence of comorbidities such as hypertension, cancer/malignancy, diabetes mellitus, chronic heart disease, and chronic kidney failure.
- Dose of propofol during anesthesia induction.
- Dose of fentanyl administered during anesthesia induction.
- Dose of midazolam administered during anesthesia induction.
- Frailty score.
This study is an observational analytical study with a prospective cohort design. Data will be collected from medical records and direct observation of geriatric patients who meet the inclusion and exclusion criteria. Sampling will be done using a consecutive sampling method. The targeted sample size is 333 subjects, accounting for a 10% dropout rate.
Study subjects will meet the inclusion criteria: geriatric patients over 60 years old undergoing elective non-cardiac surgery under general anesthesia with ASA (American Society of Anesthesiologists) classification I-IV. Exclusion criteria include patients receiving a combination of general anesthesia with regional or epidural anesthesia, more than 2 attempts at endotracheal intubation, patients already intubated before the surgical procedure, those receiving vasopressors or inotropics before general anesthesia induction, and intentional hypotension within 20 minutes after intubation.
The data to be recorded include patient characteristics, ASA classification, history of comorbidities, medications consumed, vital signs (before entering the operating room, upon arrival in the operating room, immediately after intubation, and at 5, 10, 15, and 20 minutes after intubation), type of surgery, anesthesia technique, type of anesthetic gas used, total doses of propofol, fentanyl, and midazolam with their administration times, laboratory results, chest X-ray results, presence or absence of endotracheal intubation procedure, administration of vasopressors or inotropics before induction, and patient position during blood pressure measurements. Data analysis will be performed using Graphpad Prism version 10 for MacOS, including descriptive analysis, normality tests, bivariate tests (Chi-square or Fisher's exact test, T-test or Mann-Whitney), and multivariate analysis using Cox regression to identify risk factors and determine relative risk.
详细描述
Research Title: Risk Factors for Post-Induction Hypotension in Geriatric Patients Undergoing Elective Non-Cardiac Surgery Under General Anesthesia
Researcher: Dr. dr. Aida Rosita Tantri, Sp.An-TI, Subsp.An.R (K)
Institution: Department of Anesthesiology and Intensive Therapy, Faculty of Medicine, University of Indonesia, Jakarta, 2024
Background:
General anesthesia aims to achieve the anesthetic triad: loss of consciousness, loss of pain, and skeletal muscle relaxation. However, general anesthesia can also cause adverse effects, one of which is hemodynamic instability like hypotension. Hypotension is the most commonly encountered hemodynamic disturbance and can occur immediately after the completion of general anesthesia induction until the start of surgery. Post-induction hypotension carries a risk of adverse conditions such as myocardial injury, acute kidney injury, stroke, and mortality. The definition of hypotension varies, with incidence ranging from 5-99%. Some definitions mentioned include systolic blood pressure <90 mmHg or receiving at least one norepinephrine infusion at a rate of >6 micrograms (mcg) per minute within 20 minutes post-induction (Südfeld et al.), as well as a decrease in Mean Arterial Pressure (MAP) of more than 30% compared to baseline or initial data (Jor et al. and Bijker et al.). Perioperative morbidity is more frequent in the geriatric age group, making increasing age one of the predictive factors for post-induction hypotension. Other risk factors that have been studied include hypertension upon arrival in the operating room, increased fentanyl dosage, induction with propofol, and the degree of frailty. By understanding these risk factors, it is hoped that complications from post-induction hypotension can be prevented.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Geriatric patients aged over 60 years undergoing elective non-cardiac surgical procedures under general anesthesia, with ASA (American Society of Anesthesiologists) classification I-IV.
排除标准
- •Patients receiving a combination of general anesthesia with regional or epidural anesthesia, more than 2 attempts at endotracheal intubation, patients already intubated before the surgical procedure, those receiving vasopressors or inotropic infusions before general anesthesia induction, and intentional hypotension within 20 minutes after intubation.
研究组 & 干预措施
Geriatric Patients Receiving General Anesthesia for Elective Non-Cardiac Surgery
This arm includes geriatric patients (aged 60 years and older) undergoing elective non-cardiac surgery under general anesthesia. The study will observe and record the occurrence of post-induction hypotension and evaluate various patient-related and anesthesia-related risk factors that may contribute to its development. No experimental intervention will be administered as this is an observational study.
干预措施: Standard General Anesthesia Induction Using Propofol, Fentanyl and Midazolam (Drug)
Geriatric Patients Receiving General Anesthesia for Elective Non-Cardiac Surgery
This arm includes geriatric patients (aged 60 years and older) undergoing elective non-cardiac surgery under general anesthesia. The study will observe and record the occurrence of post-induction hypotension and evaluate various patient-related and anesthesia-related risk factors that may contribute to its development. No experimental intervention will be administered as this is an observational study.
干预措施: Blood Pressure Continous Monitoring, syrnge pump for the anesthesia agent, and vasoconstrictor drug (Device)
结局指标
主要结局
Association Between Pre-Induction Risk Factors and Post-Induction Hypotension
时间窗: Baseline to 20 minutes post-induction
Hypotension is defined as a decrease in mean arterial pressure (MAP) of more than 20% from baseline or MAP \< 65 mmHg within 10 minutes after induction. The study will record the presence or absence of hypotension in each participant.
次要结局
未报告次要终点
研究者
Aida Rosita Tantri
Dr. dr. Aida Rosita Tantri, Sp.An-TI, Subsp. AR (K)
Indonesia University
