Anesthesia Induction with the Target-controlled Infusion of Propofol in High-risk Patients
NCT ID: NCT06535230
Last Updated: 2025-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2024-08-30
2025-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Group 1: Patients who underwent manual anesthesia induction Group 2 : Patients who underwent anesthesia induction with target-controlled infusion,
SCREENING
NONE
Study Groups
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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
Manual anesthesia induction
In manual anesthesia induction, anesthetic agents are administered at a fixed dose and rate adjusted according to the patient's weight
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.
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
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.
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.
Interventions
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Manual anesthesia induction
In manual anesthesia induction, anesthetic agents are administered at a fixed dose and rate adjusted according to the patient's weight
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Underwent major elective surgery
* Required intra-arterial blood pressure monitoring before induction.
Exclusion Criteria
* 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
18 Years
100 Years
ALL
No
Sponsors
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Acibadem University
OTHER
Responsible Party
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Principal Investigators
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Fevzi Toraman, M.D.
Role: STUDY_DIRECTOR
Acibadem Mehmet Ali Aydinlar University School of Medicine, Department of Anesthesiology
Locations
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Acibadem Altunizade Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Other Identifiers
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ATADEK-2024
Identifier Type: -
Identifier Source: org_study_id
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