Clinical trial NCT05708638: Target-controlled Infusion Anesthesia and Post-induction Hypotension
Official title: Does Anesthesia Induction With Target-controlled Infusion Reduce Post-induction Hypotension?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Anesthesia
Hemodynamic Instability
Keywords: General anesthesia
Target controlled infusion
Post-induction hypotension
Monitoring
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: SCREENING

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

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

Primary outcomes:
measure: 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
timeFrame: The duration of the study was defined from one minute before induction to 10 minutes after induction
measure: 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
timeFrame: The duration of the study was defined from one minute before induction to 10 minutes after induction
measure: 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
timeFrame: The duration of the study was defined from one minute before induction to 10 minutes after induction
Secondary outcomes:
measure: 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
timeFrame: he duration of the study was defined from one minute before induction to 10 minutes after induction
measure: 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
timeFrame: The duration of the study was defined from one minute before induction to 10 minutes after induction]
measure: 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
timeFrame: The duration of the study was defined from one minute before induction to 10 minutes after induction
measure: 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
timeFrame: The duration of the study was defined from one minute before induction to 10 minutes after induction
measure: 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
timeFrame: The duration of the study was defined from one minute before induction to 10 minutes after induction
measure: Dp/Dt, measured before anesthesia induction were assessed for prediction of post-induction hypotension in patients undergoing general anesthesia induction with TCI or manual
timeFrame: The duration of the study was defined from one minute before induction to 10 minutes after induction
measure: 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
timeFrame: The duration of the study was defined from one minute before induction to 10 minutes after induction
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acibadem Altunizade Hospital
Study officials:
References:
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.
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.
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.
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.
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.
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.