Anesthesia Induction with the Target-controlled Infusion of Propofol in High-risk Patients

Does Induction of Anesthesia with Target-controlled Propofol Infusion Reduce the Risk of Post-induction Hypotension in High-risk Patients?

The purpose of this study is to compare the risk of hypotension following induction of anesthesia in high-risk patients (American Society of Anesthesiologists risk scores III and IV) using target-controlled infusion (TCI) of propofol versus standard manual induction of anesthesia. Our previously published study compared TCI and manual induction of anesthesia in a general patient population and found that hypotension developed less with TCI induction. This study is a continuation of the other study and will be conducted in high-risk patients.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia; Hemodynamic Instability
• Intervention / Treatment: Drug: Manual anesthesia induction; Device: Hemodynamic monitoring with pressure recording analytical method (PRAM); Drug: Anesthesia induction with Target controlled infusions (TCI)

Detailed Description

Hypotension after induction of anesthesia is a very common condition. Despite well-known risk factors and advanced monitoring techniques, hypotension after induction of anesthesia occurs in approximately 30% of patients. The risk of hypotension increases in patients with comorbidities such as hypertension, heart failure, renal failure, diabetes mellitus, patients with high ASA (American Society of Anesthesiologists ) risk scores, geriatric patients, patients undergoing major surgery, and patients with prolonged fasting periods. In order to prevent post-induction hypotension, the risk factors of the patient (such as comorbidities, and surgery) cannot be changed, but this risk can be reduced with different anesthesia induction techniques.

Since anesthetic agents are administered at a fixed dose and rate adjusted according to the patient's weight in standard anesthesia induction, it may cause hypotension in patients with low cardiovascular performance.

The fall in blood pressure is due to a decrease in systemic vascular resistance or cardiac output and may be increased by the concomitant use of other drugs such as remifentanil. Target-controlled infusions (TCI) have been developed to overcome these drawbacks of standard anesthesia induction and maintenance. TCI systems enable titration of anesthetic agents according to the needs of each patient by using pharmacokinetic models through perfusers with special microprocessors. With these features, TCI can provide better control of hemodynamic variations during induction and maintenance of anesthesia. Patients will undergo hemodynamic monitoring using the pressure analytic recording method (PRAM). The functional hemodynamic data provided by this monitoring technique will allow us to better analyze the causes and consequences of hypotension. In this study, investigators aimed to monitor and compare the hemodynamic effects of TCI induction and manual anesthesia induction through PRAM parameters by monitoring patients with high ASA scores before and after induction. Investigators anticipate that these 2 technologies (TCI and PRAM) can provide a better hemodynamic profile in the high-risk patient group with high ASA scores thanks to the advanced monitoring provided to the patient in our anesthesia practice.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Serap A Aktas Yildirim, MD; Phone Number: +905325605077; Email: serapaktas79@yahoo.com.tr
• Study Contact Backup: Name: Zeynep Tugce Sarikaya, M.D.; Email: lredzheb@gmail.com

Study Locations

• Turkey
  • Istanbul, Turkey
    • Recruiting
    • Acibadem Altunizade Hospital
    • Contact: Serap Aktas Yildirim, MD; Phone Number: +905325605077; Email: serapaktas79@yahoo.com.tr
    • Contact: Zeynep T Sarikaya, MD; Email: tugcesrky@gmail.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patients with the American Society of Anesthesiology physical status 3-4
• Underwent major elective surgery
• Required intra-arterial blood pressure monitoring before induction.

Exclusion Criteria:

• Under 18 years of age
• Patients with the American Society of Anesthesiology physical status 1-2
• Arrhythmia (atrial fibrillation, frequent premature beat)
• Severe valvular heart disease
• Morbid obesity
• Intubation difficulty
• Drug addiction
• Treatment with opiates
• Pregnancy
• Emergency surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patients who were assigned to have manual anesthesia induction group with propofol; Patients who were assigned to have a manual anesthesia induction group, propofol was administered 1-2 mg/kg in 1-2 minutes to achieve a level of hypnosis measured by bispectral index ( BIS ) of 35-60	Drug: Manual anesthesia induction; In manual anesthesia induction, anesthetic agents are administered at a fixed dose and rate adjusted according to the patient's weight; Other Names: Manuel induction; Device: Hemodynamic monitoring with pressure recording analytical method (PRAM); The pulse contour device MostCare (Vytech, Vygon, Padova, Italy) provides functional hemodynamic monitoring using the pressure recording analytical method.
Active Comparator: Patients who were assigned to have target controlled infusions ( TCI) induction with propofol; Patients who were assigned to have TCI induction had the target effect site concentration (Ce) of propofol (Ce) set at 1 μg ml-1 using the Schneider model and subsequently modified to achieve and maintain a level of hypnosis measured by BIS of 35-55	Device: Hemodynamic monitoring with pressure recording analytical method (PRAM); The pulse contour device MostCare (Vytech, Vygon, Padova, Italy) provides functional hemodynamic monitoring using the pressure recording analytical method.; Drug: Anesthesia induction with Target controlled infusions (TCI); Target controlled infusion (TCI) system aims to reach the theoretically targeted blood or brain concentration of anesthetic agents based on the patient's age, weight, and height, with computer-assisted algorithms.; Other Names: TCI induction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic arterial pressure (SAP), measured before and after anesthesia induction was assessed to determine of post-induction hypotension in patients undergoing general anesthesia induction with TCI (target controlled infusion) or manual	Systolic arterial pressure (SAP- mm/Hg) was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). SAP is a parameter used to assess the pressure of the arterial system during cardiac systole	The duration of the study was defined from one minute before induction to 10 minutes after induction
Mean arterial pressure (MAP), measured before and after anesthesia induction was assessed to determine of post-induction hypotension in patients undergoing general anesthesia induction with TCI (target controlled infusion) or manual	Mean arterial pressure (MAP, mm/Hg) was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). MAP is a parameter used to assess organ perfusion	The duration of the study was defined from one minute before induction to 10 minutes after induction
Diastolic arterial pressure (DAP), measured before and after anesthesia induction was assessed to determine of post-induction hypotension in patients undergoing general anesthesia induction with TCI (target controlled infusion) or manual	Diastolic arterial pressure (DAP, mm/Hg) was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). DAP is a parameter used to assess the pressure of the arterial system during cardiac diastole	The duration of the study was defined from one minute before induction to 10 minutes after induction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulse pressure variation (PPV), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia induction with TCI or manual	Pulse pressure variation (PPV,%) was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). PPV is a parameter used to asses cardiac preload and fluid responsiveness.	The duration of the study was defined from one minute before induction to 10 minutes after induction
Cardiac power output (CPO), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia induction with TCI or manual	Cardiac power output (CPO, Watt) was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). CPO is a parameter used to asses cardiac reserve	The duration of the study was defined from one minute before induction to 10 minutes after induction
Cardiac index (CI), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia induction with TCI or manual	Cardiac index (CI, L/min/m2), was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). CI is a parameter used to asses cardiac stroke volume	The duration of the study was defined from one minute before induction to 10 minutes after induction
Heart rate (HR), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia induction with TCI or manual	Heart rate (HR/bpm) was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). HR is a parameter used to assess the cardiac rate.	The duration of the study was defined from one minute before induction to 10 minutes after induction
Arterial elastance (Ea) measured before anesthesia induction was investigated whether is a predictive parameter for post-induction hypotension in patients undergoing general anesthesia with TCI or manual	Ea ((mmHg m-2ml-1)is an indicator of cardiac afterload and arterial tone and can be calculated by the ratio of the end-systolic pressure (ESP) and stroke volume (SV) obtained from arterial wave analysis. Ea was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy) before the anesthesia induction	The duration of the study was defined from one minute before induction to 10 minutes after induction
Stroke volume variation (SVV), measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia induction with TCI and manual	Stroke volume variation (SVV,%), was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). SVV is a parameter used to asses cardiac preload and fluid responsiveness	The duration of the study was defined from one minute before induction to 10 minutes after induction
Dp/Dt, measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia induction with TCI or manual	Dp/Dt(mmHg/msn), was monitored using the uncalibrated pulse contour device MostCare (Vytech, Vygon, Padova, Italy). Dp/Dt is a parameter used to asses cardiac contractility	The duration of the study was defined from one minute before induction to 10 minutes after induction

Collaborators and Investigators

• Sponsor: Acibadem University
• Investigators: Study Director: Fevzi Toraman, M.D., Acibadem Mehmet Ali Aydinlar University School of Medicine, Department of Anesthesiology

Publications and helpful links

General Publications

• Billard V, Moulla F, Bourgain JL, Megnigbeto A, Stanski DR. Hemodynamic response to induction and intubation. Propofol/fentanyl interaction. Anesthesiology. 1994 Dec;81(6):1384-93. doi: 10.1097/00000542-199412000-00013.
• Saugel B, Sessler DI. Perioperative Blood Pressure Management. Anesthesiology. 2021 Feb 1;134(2):250-261. doi: 10.1097/ALN.0000000000003610. No abstract available.
• Sessler DI, Khan MZ, Maheshwari K, Liu L, Adegboye J, Saugel B, Mascha EJ. Blood Pressure Management by Anesthesia Professionals: Evaluating Clinician Skill From Electronic Medical Records. Anesth Analg. 2021 Apr 1;132(4):946-956. doi: 10.1213/ANE.0000000000005198.
• Gao Q, Sun L. Hypotension during induction: prediction or prevention? J Anesth. 2020 Apr;34(2):308. doi: 10.1007/s00540-019-02710-9. Epub 2019 Nov 9. No abstract available.
• Kazama T, Ikeda K, Morita K, Kikura M, Doi M, Ikeda T, Kurita T, Nakajima Y. Comparison of the effect-site k(eO)s of propofol for blood pressure and EEG bispectral index in elderly and younger patients. Anesthesiology. 1999 Jun;90(6):1517-27. doi: 10.1097/00000542-199906000-00004.
• Yildirim SA, Dogan L, Sarikaya ZT, Ulugol H, Gucyetmez B, Toraman F. Hypotension after Anesthesia Induction: Target-Controlled Infusion Versus Manual Anesthesia Induction of Propofol. J Clin Med. 2023 Aug 14;12(16):5280. doi: 10.3390/jcm12165280.

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2024
• Primary Completion (Estimated): May 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: July 18, 2024
• First Submitted That Met QC Criteria: July 31, 2024
• First Posted (Actual): August 2, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 30, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Anesthesia induction; Post-induction hypotension; High-risk patients; Target controlled infusions
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypotension; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: ATADEK-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No