Target-controlled Infusion Anesthesia and Post-induction Hypotension

General Anesthesia Clinical Trial

Official title:

Does Anesthesia Induction With Target-controlled Infusion Reduce Post-induction Hypotension?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05708638
• Other study ID #: ATADEK 2022-18/04
• Status: Completed
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: August 10, 2023

Study information

• Verified date: August 2023
• Source: Acibadem University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hemodynamic changes during induction of anesthesia may have adverse outcomes and should therefore be avoided. The decrease in blood pressure during induction of anesthesia with propofol 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 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. In manual anesthesia induction, anesthetic agents are administered at a fixed dose and rate adjusted according to the patient's weight, which may cause hypotension in patients with low cardiovascular performance. As target-controlled infusion (TCI) obviates the need to calculate the infusion rate manually, the use of TCI may provide a better hemodynamic profile during anesthesia induction This study was designed to test the hypothesis that propofol by TCI anesthesia induction is associated with a lower hypotension rate when compared with manual anesthesia induction

Description:

Maintaining normotension is one of the top priorities for anesthesiologists due to its negative effects. Although there are a lot of studies and knowledge on the topic approximately 20-30% of patients develop post-induction hypotension. Mostly it occurs due to the adverse effects of anesthetics such as a decrease in systemic vascular resistance or cardiac output and the interplay between them. The risk can be minimized in two steps: first by identifying high-risk patients, and second with tight control of hemodynamic parameters. As a second step, tight hemodynamic control during induction may be done using target-controlled infusion (TCI) systems, which systems help to adjust the dosage to the needs of each patient by measuring hypnotic effects through the bispectral index (BIS).

TCI models for propofol have been previously compared with manual infusions, however, it is not clear whether it still contributes to or triggers hemodynamic deterioration. Therefore in this study, the investigators' aim is to determine the effect of two different anesthesia techniques on the development of postinduction hypotension through hemodynamic parameters monitored by the pressure recording analytical method (PRAM). The secondary aim is to identify risk factors that can predict postinduction hypotension

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 10, 2023
• Est. primary completion date: August 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients with the American Society of Anesthesiology physical status 1-3

• Underwent major elective surgery

• Required intra-arterial blood pressure monitoring before induction.

Exclusion Criteria:

• Under 18 years of age

• Arrhythmia (atrial fibrillation, frequent premature beat)

• Severe valvular heart disease

• Morbid obesity

• Intubation difficulty

• Drug addiction

• Treatment with opiates

• Pregnancy

• Emergency surgery

Related Conditions & MeSH terms

• General Anesthesia
• Hemodynamic Instability
• Hypotension

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Turkey	Acibadem Altunizade Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

Guarracino F, Lapolla F, Cariello C, Danella A, Doroni L, Baldassarri R, Boldrini A, Volpe ML. Target controlled infusion: TCI. Minerva Anestesiol. 2005 Jun;71(6):335-7. — View Citation

Hsieh ML, Lu YT, Lin CC, Lee CP. Comparison of the target-controlled infusion and the manual infusion of propofol anesthesia during electroconvulsive therapy: an open-label randomized controlled trial. BMC Psychiatry. 2021 Feb 4;21(1):71. doi: 10.1186/s12888-021-03069-6. — View Citation

Leslie K, Clavisi O, Hargrove J. Target-controlled infusion versus manually-controlled infusion of propofol for general anaesthesia or sedation in adults. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD006059. doi: 10.1002/14651858.CD006059.pub2. — View Citation

Marik PE. Noninvasive cardiac output monitors: a state-of the-art review. J Cardiothorac Vasc Anesth. 2013 Feb;27(1):121-34. doi: 10.1053/j.jvca.2012.03.022. Epub 2012 May 19. No abstract available. — View Citation

Mu J, Jiang T, Xu XB, Yuen VM, Irwin MG. Comparison of target-controlled infusion and manual infusion for propofol anaesthesia in children. Br J Anaesth. 2018 May;120(5):1049-1055. doi: 10.1016/j.bja.2017.11.102. Epub 2018 Feb 3. — View Citation

Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anest — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Secondary	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	he duration of the study was defined from one minute before induction to 10 minutes after induction
Secondary	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]
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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