What Causes Low Blood Pressure After Anesthesia in Older Adults Having Non-Heart Surgery ?

NCT07019805 | Completed Phase 3 DMC FDA Drug FDA Device

• 1 other identifier: 24-08-1341
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• Airway management with endotracheal intubation.
• Low albumin levels.
• Presence of comorbidities such as hypertension, cancer/malignancy, diabetes mellitus, chronic heart disease, and chronic kidney failure.
• Dose of propofol during anesthesia induction.
• Dose of fentanyl administered during anesthesia induction.
• Dose of midazolam administered during anesthesia induction.
• Frailty score. 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.

Conditions

Geriatric; General Anesthesia Induced Hypotension; Elective Surgery; Hypotension; Risk Factor

Keywords

Geriatric; Hypotension; General Anesthesia; Risk Factor

Outcome Measures

Primary Outcomes (1)

• Association Between Pre-Induction Risk Factors and Post-Induction Hypotension

  Hypotension is defined as a decrease in mean arterial pressure (MAP) of more than 20% from baseline or MAP \< 65 mmHg within 10 minutes after induction. The study will record the presence or absence of hypotension in each participant.

  Baseline to 20 minutes post-induction

Study Arms (1)

Geriatric Patients Receiving General Anesthesia for Elective Non-Cardiac Surgery

OTHER

This arm includes geriatric patients (aged 60 years and older) undergoing elective non-cardiac surgery under general anesthesia. The study will observe and record the occurrence of post-induction hypotension and evaluate various patient-related and anesthesia-related risk factors that may contribute to its development. No experimental intervention will be administered as this is an observational study.

Drug: Standard General Anesthesia Induction Using Propofol, Fentanyl and Midazolam; Device: Blood Pressure Continous Monitoring, syrnge pump for the anesthesia agent, and vasoconstrictor drug

Interventions

Standard General Anesthesia Induction Using Propofol, Fentanyl and Midazolam DRUG

This intervention refers to the standard induction of general anesthesia in geriatric patients undergoing elective non-cardiac surgery. Induction typically involves the administration of intravenous anesthetic agents such as propofol and fentanyl, based on institutional protocols and the anesthesiologist's discretion. This study does not modify or introduce any new treatment; it merely observes and records peri-induction parameters to identify factors associated with the occurrence of post-induction hypotension.

Geriatric Patients Receiving General Anesthesia for Elective Non-Cardiac Surgery

Blood Pressure Continous Monitoring, syrnge pump for the anesthesia agent, and vasoconstrictor drug DEVICE

This intervention involves the standard clinical use of non-invasive continuous blood pressure monitoring during the induction of general anesthesia in geriatric patients undergoing elective non-cardiac surgery. Intravenous anesthetic agents (e.g., propofol, fentanyl) and vasopressors (e.g., ephedrine, norepinephrine) are administered via syringe pumps based on the anesthesiologist's clinical judgment. The study does not introduce any experimental treatment but observes blood pressure changes in real time to identify risk factors for post-induction hypotension. The integration of continuous hemodynamic monitoring distinguishes this observational approach from routine anesthetic induction without such monitoring.

Geriatric Patients Receiving General Anesthesia for Elective Non-Cardiac Surgery

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Geriatric patients aged over 60 years undergoing elective non-cardiac surgical procedures under general anesthesia, with ASA (American Society of Anesthesiologists) classification I-IV.

You may not qualify if:

• 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 inotropic infusions before general anesthesia induction, and intentional hypotension within 20 minutes after intubation.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Kepk Fkui-Rscm

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Related Publications (8)

• Reich DL, Hossain S, Krol M, Baez B, Patel P, Bernstein A, Bodian CA. Predictors of hypotension after induction of general anesthesia. Anesth Analg. 2005 Sep;101(3):622-628. doi: 10.1213/01.ANE.0000175214.38450.91.

  PMID: 16115962 BACKGROUND

• Sutthibenjakul K, Chatmongkolchart S. Risk factors for postinduction hypotension among elderly patients undergoing elective non-cardiac surgery under general anesthesia. Journal of Health Science and Medical Research. 2021;39(5).

  BACKGROUND

• Lim BG, Lee IO. Anesthetic management of geriatric patients. Korean J Anesthesiol. 2020 Feb;73(1):8-29. doi: 10.4097/kja.19391. Epub 2019 Oct 22.

  PMID: 31636241 BACKGROUND

• Jor O, Maca J, Koutna J, Gemrotova M, Vymazal T, Litschmannova M, Sevcik P, Reimer P, Mikulova V, Trlicova M, Cerny V. Hypotension after induction of general anesthesia: occurrence, risk factors, and therapy. A prospective multicentre observational study. J Anesth. 2018 Oct;32(5):673-680. doi: 10.1007/s00540-018-2532-6. Epub 2018 Jul 19.

  PMID: 30027443 BACKGROUND

• Bijker JB, Persoon S, Peelen LM, Moons KG, Kalkman CJ, Kappelle LJ, van Klei WA. Intraoperative hypotension and perioperative ischemic stroke after general surgery: a nested case-control study. Anesthesiology. 2012 Mar;116(3):658-64. doi: 10.1097/ALN.0b013e3182472320.

  PMID: 22277949 BACKGROUND

• de la Hoz MA, Rangasamy V, Bastos AB, Xu X, Novack V, Saugel B, Subramaniam B. Intraoperative Hypotension and Acute Kidney Injury, Stroke, and Mortality during and outside Cardiopulmonary Bypass: A Retrospective Observational Cohort Study. Anesthesiology. 2022 Jun 1;136(6):927-939. doi: 10.1097/ALN.0000000000004175.

  PMID: 35188970 BACKGROUND

• Mangku G, Senaphati TGA. Buku ajar ilmu anastesia dan reanimasi. PT Indeks. 2010.

  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

MeSH Terms

Conditions

Hypotension

Interventions

Fentanyl; Midazolam

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. dr. Aida Rosita Tantri, Sp.An-TI, Subsp. AR (K)

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 13, 2025
• Study Start: September 1, 2024
• Primary Completion: March 15, 2025
• Study Completion: March 15, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)