Incidence and Risk Factors of Post-Induction Hypotension in Geriatric Cancer Patients

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

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.

Study Overview

• Status: Recruiting
• Conditions: Oncologic Disease; Geriatric Patient; Post-induction Hypotension (PIH); Hemodynamic Effects of General Anesthesia; Risk Factors Associated With Anesthesia-Induced Hypotension

Detailed Description

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:

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.

• Study Type: Observational
• Enrollment (Estimated): 140

Contacts and Locations

• Study Contact: Name: dolunay arık; Phone Number: +90 0554 977 44 97; Email: arikdolunay@gmail.com

Study Locations

• Turkey (Türkiye)
  • Ankara
    • Ankara, Ankara, Turkey (Türkiye), 06200
      • Recruiting
      • Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
      • Contact: dolunay arık; Phone Number: +90 0554 977 44 97; Email: arikdolunay@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of geriatric patients (≥65 years) undergoing oncologic surgery at Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital, Ankara, Turkey.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Post-Induction Hypotension (PIH) in Geriatric Oncologic Patients	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.	From anesthesia induction to 15 minutes after intubation (≈ first 20 minutes post-induction)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association of Demographic, Oncologic, and Anesthetic Factors With Post-Induction Hypotension	Secondary objectives include evaluating the relationship between PIH and patient characteristics such as age, ASA classification, cancer diagnosis, type of oncologic treatments received, comorbidities, regular medication use, preoperative anemia, selected biochemical parameters, perfusion index (PI) and pleth variability index (PVI) measurements, as well as the anesthetic induction method.	From preoperative assessment to 20 minutes after anesthesia induction

Collaborators and Investigators

• Sponsor: Dolunay ARIK

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2025
• Primary Completion (Estimated): May 25, 2026
• Study Completion (Estimated): May 25, 2026

Study Registration Dates

• First Submitted: December 7, 2025
• First Submitted That Met QC Criteria: December 7, 2025
• First Posted (Actual): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 7, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Hemodynamics; General Anesthesia; Pleth Variability Index (PVI); geriatric patient; Post-induction Hypotension; Perfusion Index (PI); Oncologic Patients
• Other Study ID Numbers: 2025-05/70

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share IPD publicly. Interested researchers may contact the principal investigator for data access