A Prospective Observational Study to Determine the Incidence and Risk Factors of Post-Induction Hypotension in Geriatric Oncologic Patients Undergoing General Anesthesia at a Tertiary Oncology Center
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Incidence of Post-Induction Hypotension (PIH) in Geriatric Oncologic Patients
研究概览
简要总结
This observational clinical study aims to investigate the incidence and risk factors of post-induction hypotension (PIH) in geriatric cancer patients undergoing surgery under general anesthesia. PIH is defined as a drop in mean arterial pressure of ≥30% from baseline or below 65 mmHg within the first 20 minutes after anesthesia induction, prior to surgical stimulation.
The primary objective is to determine the frequency of PIH in elderly oncology patients. Secondary objectives include evaluating the association of PIH with age, ASA score, cancer type, oncological treatments (chemotherapy/radiotherapy), comorbidities, medication use, anemia, biochemical parameters, and preoperative perfusion index (PI) and pleth variability index (PVI).
Findings from this study are expected to contribute to improved perioperative management and to the development of tailored anesthesia protocols for geriatric oncology patients.
详细描述
This study will be conducted as a prospective observational trial at SBÜ Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital, Department of Anesthesiology and Reanimation, with the aim of evaluating the incidence and risk factors of post-induction hypotension (PIH) in geriatric oncology patients. The study will commence after institutional ethics committee approval, and written informed consent will be obtained from all participants.
Standard monitoring (ECG, non-invasive blood pressure, SpO₂) will be applied in the operating room. Pre-induction values will be recorded after a 5-minute rest period. Perfusion index (PI) and pleth variability index (PVI) will be measured using the Massimo Root® with Radical-7 monitor from the non-cannulated hand, with three consecutive readings averaged.
Demographic data (age, sex, height, weight, BMI), comorbidities, regular medications, type of malignancy, history of chemotherapy/radiotherapy, and preoperative laboratory values will be documented.
Anesthesia induction will be performed with propofol (1.5-2.5 mg/kg), fentanyl (1-2 μg/kg), lidocaine (1-1.5 mg/kg), and rocuronium (0.6 mg/kg). Maintenance will be achieved using sevoflurane (1.5-2%) or desflurane (5-6%), O₂/air mixture, and remifentanil (0.1-0.2 μg/kg/min). Drugs and doses used during induction will be recorded.
PIH is defined as hypotension occurring within the first 20 minutes after induction, prior to surgical stimulation. Criteria:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥65 years of age
- •Patients with a diagnosis of cancer and scheduled for surgery
- •Ability and willingness to provide written informed consent
- •ASA physical status class II-IV
排除标准
- •Patients under 65 years of age
- •Patients without a confirmed oncologic diagnosis
- •Refusal to provide written informed consent
- •Patients undergoing regional anesthesia
- •Patients with tracheostomy or requiring multiple intubation attempts
- •History of peripheral arterial disease
- •Use of vasopressors before the start of surgery
- •Uncontrolled hypertension (blood pressure >180/110 mmHg)
- •Advanced heart failure (Ejection Fraction <40%)
- •Severe arrhythmias such as atrial fibrillation or significant ventricular arrhythmias that preclude reliable hemodynamic monitoring
结局指标
主要结局
Incidence of Post-Induction Hypotension (PIH) in Geriatric Oncologic Patients
时间窗: From anesthesia induction to 15 minutes after intubation (≈ first 20 minutes post-induction)
PIH defined as ≥30% decrease from pre-induction MAP or MAP \< 65 mmHg at any measurement within the window (NIBP every 2 minutes). Outcome reported as the proportion of participants meeting PIH criteria.
次要结局
- Association of Demographic, Oncologic, and Anesthetic Factors With Post-Induction Hypotension(From preoperative assessment to 20 minutes after anesthesia induction)
研究者
Dolunay ARIK
Resident doctor
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital