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NCT Number: NCT06535230

Anesthesia Induction with the Target-controlled Infusion of Propofol 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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manual anesthesia induction

Drug

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

Anesthesia induction with Target controlled infusions (TCI)

Drug

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

Hemodynamic monitoring with pressure recording analytical method (PRAM)

Device

The pulse contour device MostCare (Vytech, Vygon, Padova, Italy) provides functional hemodynamic monitoring using the pressure recording analytical method.

Primary outcomes

  1. 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

    Time frame: The duration of the study was defined from one minute before induction to 10 minutes after induction

    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

  2. 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

    Time frame: The duration of the study was defined from one minute before induction to 10 minutes after induction

    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

  3. 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

    Time frame: The duration of the study was defined from one minute before induction to 10 minutes after induction

    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

Secondary outcomes

  1. 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

    Time frame: The duration of the study was defined from one minute before induction to 10 minutes after induction

    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

  2. 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

    Time frame: The duration of the study was defined from one minute before induction to 10 minutes after induction

    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

  3. 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

    Time frame: The duration of the study was defined from one minute before induction to 10 minutes after induction

    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.

  4. 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

    Time frame: The duration of the study was defined from one minute before induction to 10 minutes after induction

    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

  5. 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

    Time frame: The duration of the study was defined from one minute before induction to 10 minutes after induction

    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

  6. Dp/Dt, measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia induction with TCI or manual

    Time frame: The duration of the study was defined from one minute before induction to 10 minutes after induction

    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

  7. 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

    Time frame: The duration of the study was defined from one minute before induction to 10 minutes after induction

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Serap A Aktas Yildirim, MD

CONTACT

[email protected]

+905325605077

Zeynep Tugce Sarikaya, M.D.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 2, 2024
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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