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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:
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.
Full description
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.
Problem Statement:
Post-induction hypotension in general anesthesia, characterized by a decrease in MAP >30% compared to baseline MAP, is a common complication with extensively described negative effects. Although various factors have been studied to predict the occurrence of post-anesthesia hypotension, specific studies on geriatric patients undergoing elective non-cardiac surgery under general anesthesia have not yet been conducted in Indonesia, particularly at Dr. Cipto Mangunkusumo National Central Public Hospital.
Research Questions:
Research Hypotheses:
Research Objectives:
General Objective: To identify risk factors for post-induction hypotension in geriatric patients undergoing non-cardiac surgery under general anesthesia at Dr. Cipto Mangunkusumo National Central Public Hospital.
Specific Objectives:
Research Benefits:
The results of this study are expected to provide useful information for researchers, educational institutions, and public services. By identifying risk factors for post-induction hypotension, it is hoped that this can serve as a basis for prevention efforts, minimization, and appropriate management of the negative effects of post-induction hypotension, especially for the geriatric population undergoing general anesthesia. For educational institutions, this research will add information and knowledge to predict and minimize the negative effects of post-induction hypotension. For the community, it is expected to provide information and education about risk factors for post-induction hypotension, especially for geriatrics undergoing surgery with general anesthesia. For researchers, these results can serve as a basis and reference for further research development, as well as contribute knowledge on risk factors for post-induction hypotension in geriatric patients undergoing non-cardiac surgery.
Research Methodology:
Target Population: All geriatric patients undergoing elective non-cardiac surgical procedures under general anesthesia at Dr. Cipto Mangunkusumo National Central Public Hospital.
Research Procedure:
Research Variables:
Operational Definition: Detailed definitions and methods of measurement for each variable (gender, age, BMI, ASA classification, post-induction hypotension, airway management, albumin levels, comorbid diseases, pulse rate, MAP before and after induction, T0, TEI, T5, T10, T15, T20, propofol dose, fentanyl dose, midazolam dose, frailty score) are presented in a table.
Data Analysis: Analysis will be performed using Graphpad Prism version 10 for MacOS. The analysis stages include descriptive analysis, normality testing (Kolmogorov Smirnov test), presentation of categorical data (counts and percentages), and numerical data (mean ± standard deviation for normally distributed data, and median (min - max) for non-normally distributed data). Bivariate analysis will use the Chi-square test or Fisher's exact test for categorical data, and the unpaired T-test or Mann-Whitney test for numerical data. Multivariate analysis will be conducted on variables with a p-value < 0.25 in bivariate analysis using Cox regression to identify determinant risk factors and determine the relative risk. A 95% confidence interval will be used, with a p-value < 0.05 considered statistically significant. Receiver operating characteristic (ROC) curves will be generated to measure the discriminative power of risk factors.
Research Ethics:
Ethical approval for the research will be obtained from the Health Research Ethics Committee of the Faculty of Medicine, University of Indonesia - Dr. Cipto Mangunkusumo National Central Public Hospital. Once ethical approval and research site permits are issued, the research can commence, adhering to ethical principles: autonomy (informed consent from subjects after receiving information on objectives, procedures, benefits, and risks, ensuring confidentiality), justice (subjects will undergo anesthesia as planned, with no changes in technique, and data will only be collected from medical records), beneficence (researchers will ensure subject benefit and comfort during the study), and non-maleficence (transparent reporting to the ethics committee in case of incidents or undesirable events).
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Data sourced from clinicaltrials.gov
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