Incidence and Risk Factors of Post-Induction Hypotension in Geriatric Cancer Patients
NCT ID: NCT07294040
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
140 participants
OBSERVATIONAL
2025-05-25
2026-05-25
Brief Summary
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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.
Detailed Description
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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:
A ≥30% decrease in mean arterial pressure (MAP) compared to baseline or MAP \< 65 mmHg Any interventions for hypotension (vasopressors, intravenous fluids) will be documented.
Blood pressure measurements will be obtained at six time points:
T0: Baseline, before induction T1: After induction, prior to intubation T2: 1 minute after intubation T3: 5 minutes after intubation T4: 10 minutes after intubation T5: 15 minutes after intubation
The study will be completed after the T5 measurement, covering the first \~20 minutes following anesthesia induction.
In this study, post-induction hypotension (PIH) will be defined as either a ≥30% decrease in mean arterial pressure (MAP) compared to the pre-induction baseline value, or MAP \< 65 mmHg. The pre-induction MAP measured non-invasively will be taken as the baseline. During the first 20 minutes after induction (measured every 2 minutes), patients meeting either criterion will be classified into the "PIH present" group, while those without such changes will be classified as "PIH absent."
Sample size calculations were performed using G\*Power 3.1:
For group comparisons: Assuming a medium effect size (Cohen's d = 0.5), 80% power, and α = 0.05, 64 patients per group (128 total) are required.
For categorical variables: With a medium effect size (Cohen's w = 0.3), 108 participants are required.
For logistic regression: Based on literature, the incidence of PIH was estimated at 20%. Assuming an Odds Ratio (OR) of 2.0, a two-tailed test with 80% power and α = 0.05 indicated that at least 113 participants are needed.
All statistical analyses will be conducted using SPSS or equivalent software, with a significance threshold of p \< 0.05.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Geriatric Oncologic Patients Monitored for Post-Induction Blood Pressure
This cohort includes geriatric patients (≥65 years) with a confirmed cancer diagnosis who are scheduled for surgery under general anesthesia. The focus of the study is on monitoring and evaluating post-induction blood pressure changes. Standard non-invasive monitoring (ECG, NIBP, SpO₂) will be applied, and blood pressure will be measured at predefined intervals in the first 20 minutes following anesthesia induction. The study aims to assess the frequency and determinants of post-induction hypotension in this patient population.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Patients with a diagnosis of cancer and scheduled for surgery
Ability and willingness to provide written informed consent
ASA physical status class II-IV
Exclusion Criteria
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
65 Years
ALL
No
Sponsors
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Dolunay ARIK
OTHER
Responsible Party
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Dolunay ARIK
Resident doctor
Locations
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Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara, Ankara, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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dolunay arık
Role: primary
References
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Phillips AT, Deiner S, Mo Lin H, Andreopoulos E, Silverstein J, Levin MA. Propofol Use in the Elderly Population: Prevalence of Overdose and Association With 30-Day Mortality. Clin Ther. 2015 Dec 1;37(12):2676-85. doi: 10.1016/j.clinthera.2015.10.005. Epub 2015 Nov 6.
Sudfeld S, Brechnitz S, Wagner JY, Reese PC, Pinnschmidt HO, Reuter DA, Saugel B. Post-induction hypotension and early intraoperative hypotension associated with general anaesthesia. Br J Anaesth. 2017 Jul 1;119(1):57-64. doi: 10.1093/bja/aex127.
Bloom MW, Hamo CE, Cardinale D, Ky B, Nohria A, Baer L, Skopicki H, Lenihan DJ, Gheorghiade M, Lyon AR, Butler J. Cancer Therapy-Related Cardiac Dysfunction and Heart Failure: Part 1: Definitions, Pathophysiology, Risk Factors, and Imaging. Circ Heart Fail. 2016 Jan;9(1):e002661. doi: 10.1161/CIRCHEARTFAILURE.115.002661.
Levin MA, Fischer GW, Lin HM, McCormick PJ, Krol M, Reich DL. Intraoperative arterial blood pressure lability is associated with improved 30 day survival. Br J Anaesth. 2015 Nov;115(5):716-26. doi: 10.1093/bja/aev293. Epub 2015 Sep 22.
Abebe MM, Arefayne NR, Temesgen MM, Admass BA. Incidence and predictive factors associated with hemodynamic instability among adult surgical patients in the post-anesthesia care unit, 2021: A prospective follow up study. Ann Med Surg (Lond). 2022 Jan 29;74:103321. doi: 10.1016/j.amsu.2022.103321. eCollection 2022 Feb.
Other Identifiers
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2025-05/70
Identifier Type: -
Identifier Source: org_study_id