Perioperative Blood Pressure Management.
Bernd Saugel, Daniel I Sessler
https://pubmed.ncbi.nlm.nih.gov/33206118Actively Recruiting
Led by Acibadem University · Updated on 2025-02-03
200
Participants Needed
1
Research Sites
4 weeks
Total Duration
Researchers are investigating the risk of low blood pressure (hypotension) after anesthesia induction in high-risk patients with serious health conditions, classified as American Society of Anesthesiologists (ASA) physical status 3 or 4. This study compares a new method called target-controlled infusion (TCI) of propofol to the standard manual anesthesia induction. Previous research showed TCI may cause less hypotension in general patients, and this trial continues that work focusing on patients at higher risk. The study involves two groups of patients undergoing major elective surgery. One group receives manual anesthesia induction where propofol is given at a fixed dose based on weight over 1-2 minutes, aiming for a hypnosis level measured by bispectral index (BIS) of 35-60. The other group receives TCI induction where the propofol concentration is computer-controlled and adjusted to maintain a hypnosis level measured by BIS of 35-55. Both groups are monitored using a pressure recording analytical method (PRAM) device to track heart and blood vessel function during and after anesthesia induction. Participants will be monitored closely from one minute before induction to ten minutes after to measure blood pressure and heart function parameters including systolic, diastolic, and mean arterial pressures. Additional heart and circulation data such as arterial elastance, stroke volume variation, and cardiac output are recorded to predict and understand hypotension. This detailed monitoring aims to compare the effects of TCI and manual induction on blood pressure stability in these high-risk patients during anesthesia.
CONDITIONS
Anesthesia Induction with the Target-controlled Infusion of Propofol in High-risk Patients
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From 1 minute before induction to 10 minutes after induction
Participants receive anesthesia induction either manually or with target-controlled infusion (TCI) of propofol, with continuous hemodynamic monitoring using the pressure recording analytical method (PRAM).
1 anesthesia induction visit (in-person)
Total: 1 location
1
Acibadem Altunizade Hospital
Istanbul, Turkey (Türkiye)
Actively Recruiting
S
Serap A Aktas Yildirim, MD
Z
Zeynep Tugce Sarikaya, M.D.
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
2
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