Target-controlled Infusion Anesthesia and Post-induction Hypotension

NCT05708638 | Completed

• 1 other identifier: ATADEK 2022-18/04
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

General Anesthesia; Hemodynamic Instability

Keywords

General anesthesia; Target controlled infusion; Post-induction hypotension; Monitoring

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (7)

• 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

  he 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

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

• 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

  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

  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

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

Study Arms (2)

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

ACTIVE COMPARATOR

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.

Other: Manual anesthesia induction

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

ACTIVE COMPARATOR

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

Other: Anesthesia induction with Target controlled infusions (TCI)

Interventions

Manual anesthesia induction OTHER

In manual anesthesia induction, anesthetic agents are administered at a fixed dose and rate adjusted according to the patient's weight

Also known as: Manuel induction

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

Anesthesia induction with Target controlled infusions (TCI) OTHER

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.

Also known as: TCI induction

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with the American Society of Anesthesiology physical status 1-3
• Underwent major elective surgery
• Required intra-arterial blood pressure monitoring before induction.

You may not qualify if:

• 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

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acibadem Altunizade Hospital

Istanbul, 31190, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 29661382 BACKGROUND

• 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.

  PMID: 33541306 BACKGROUND

• 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.

  PMID: 23835589 RESULT

• 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.

  PMID: 15886597 RESULT

• 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.

  PMID: 18646134 RESULT

• 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.

  PMID: 22609340 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: February 1, 2023
• Study Start: December 1, 2022
• Primary Completion: August 8, 2023
• Study Completion: August 10, 2023
• Last Updated: September 18, 2023

Record last verified: 2023-08

Locations

TU (1)