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

NCT07294040 | Recruiting

• 1 other identifier: 2025-05/70
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Post-induction Hypotension; Perfusion Index (PI); Pleth Variability Index (PVI); geriatric patient; Oncologic Patients; General Anesthesia; Hemodynamics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Association of Demographic, Oncologic, and Anesthetic Factors With Post-Induction Hypotension

  From preoperative assessment to 20 minutes after anesthesia induction

Study Arms (1)

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.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dolunay ARIK: lead

Study Sites (1)

Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital

Ankara, Ankara, 06200, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• 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.

  PMID: 26548320 BACKGROUND

• 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.

  PMID: 28974066 BACKGROUND

• 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.

  PMID: 26747861 BACKGROUND

• 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.

  PMID: 26395645 BACKGROUND

• 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.

  PMID: 35145680 BACKGROUND

Central Study Contacts

Dolunay arık

CONTACT

+90 0554 977 44 97; arikdolunay@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident doctor

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: December 19, 2025
• Study Start: May 25, 2025
• Primary Completion (Estimated): May 25, 2026
• Study Completion (Estimated): May 25, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)