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Target-controlled Infusion Anesthesia and Post-induction Hypotension

Primary Purpose

General Anesthesia, Hemodynamic Instability

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Manual anesthesia induction
Anesthesia induction with Target controlled infusions (TCI)
Sponsored by
Acibadem University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for General Anesthesia focused on measuring General anesthesia, Target controlled infusion, Post-induction hypotension, Monitoring

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Acibadem Altunizade Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Patients who were assigned to have manual anesthesia induction group with propofol

Patients who were assigned to have target controlled infusions ( TCI) induction with propofol

Arm Description

Patients who were assigned to have a manual anesthesia induction group, propofol was administered 2-3 mg/kg in 1-2 minutes to achieve a level of hypnosis measured by bispectral index ( BIS ) of 35-60.

Patients who were assigned to have TCI induction had the target effect site concentration (Ce) of propofol (Ce) set at 3 μg ml-1 using the Schneider model and subsequently modified to achieve and maintain a level of hypnosis measured by BIS of 35-55

Outcomes

Primary Outcome Measures

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
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.
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

Secondary Outcome Measures

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
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
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.
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
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
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.
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.

Full Information

First Posted
January 23, 2023
Last Updated
September 15, 2023
Sponsor
Acibadem University
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1. Study Identification

Unique Protocol Identification Number
NCT05708638
Brief Title
Target-controlled Infusion Anesthesia and Post-induction Hypotension
Official Title
Does Anesthesia Induction With Target-controlled Infusion Reduce Post-induction Hypotension?
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
August 8, 2023 (Actual)
Study Completion Date
August 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acibadem University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
General Anesthesia, Hemodynamic Instability
Keywords
General anesthesia, Target controlled infusion, Post-induction hypotension, Monitoring

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-center, prospective, non-blinded, randomized controlled trial, Patients were allocated to 2 groups: Group 1 Patients who underwent anesthesia induction with target-controlled infusion, Group 2: Patients who underwent manual anesthesia induction
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients who were assigned to have manual anesthesia induction group with propofol
Arm Type
Active Comparator
Arm Description
Patients who were assigned to have a manual anesthesia induction group, propofol was administered 2-3 mg/kg in 1-2 minutes to achieve a level of hypnosis measured by bispectral index ( BIS ) of 35-60.
Arm Title
Patients who were assigned to have target controlled infusions ( TCI) induction with propofol
Arm Type
Active Comparator
Arm Description
Patients who were assigned to have TCI induction had the target effect site concentration (Ce) of propofol (Ce) set at 3 μg ml-1 using the Schneider model and subsequently modified to achieve and maintain a level of hypnosis measured by BIS of 35-55
Intervention Type
Other
Intervention Name(s)
Manual anesthesia induction
Other Intervention Name(s)
Manuel induction
Intervention Description
In manual anesthesia induction, anesthetic agents are administered at a fixed dose and rate adjusted according to the patient's weight
Intervention Type
Other
Intervention Name(s)
Anesthesia induction with Target controlled infusions (TCI)
Other Intervention Name(s)
TCI induction
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
The duration of the study was defined from one minute before induction to 10 minutes after induction
Title
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
Description
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.
Time Frame
The duration of the study was defined from one minute before induction to 10 minutes after induction
Title
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
Description
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
Time Frame
The duration of the study was defined from one minute before induction to 10 minutes after induction
Secondary Outcome Measure Information:
Title
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
Description
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
Time Frame
he duration of the study was defined from one minute before induction to 10 minutes after induction
Title
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
Description
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
Time Frame
The duration of the study was defined from one minute before induction to 10 minutes after induction]
Title
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
Description
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.
Time Frame
The duration of the study was defined from one minute before induction to 10 minutes after induction
Title
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
Description
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
Time Frame
The duration of the study was defined from one minute before induction to 10 minutes after induction
Title
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
Description
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
Time Frame
The duration of the study was defined from one minute before induction to 10 minutes after induction
Title
Dp/Dt, measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia induction with TCI or manual
Description
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.
Time Frame
The duration of the study was defined from one minute before induction to 10 minutes after induction
Title
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
Description
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.
Time Frame
The duration of the study was defined from one minute before induction to 10 minutes after induction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Acibadem Altunizade Hospital
City
Istanbul
ZIP/Postal Code
31190
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
29661382
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.
Results Reference
background
PubMed Identifier
33541306
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.
Results Reference
background
PubMed Identifier
23835589
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. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26.
Results Reference
result
PubMed Identifier
15886597
Citation
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.
Results Reference
result
PubMed Identifier
18646134
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.
Results Reference
result
PubMed Identifier
22609340
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.
Results Reference
result

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Target-controlled Infusion Anesthesia and Post-induction Hypotension

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