Actively Recruiting

Phase Not Applicable
Age: 18Years - 100Years
All Genders
ID06535230

Does Induction of Anesthesia with Target-controlled Propofol Infusion Reduce the Risk of Post-induction Hypotension in High-risk Patients?

Led by Acibadem University · Updated on 2025-02-03

200

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief Title

Anesthesia Induction with the Target-controlled Infusion of Propofol in High-risk Patients

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with the American Society of Anesthesiology physical status 3-4
  • Underwent major elective surgery
  • Required intra-arterial blood pressure monitoring before induction
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Patients with the American Society of Anesthesiology physical status 1-2
  • Arrhythmia (atrial fibrillation, frequent premature beat)
  • Severe valvular heart disease
  • Morbid obesity
  • Intubation difficulty
  • Drug addiction
  • Treatment with opiates
  • Pregnancy
  • Emergency surgery

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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)

Trial Site Locations

Total: 1 location

1

Acibadem Altunizade Hospital

Istanbul, Turkey (Türkiye)

Actively Recruiting

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Research Team

S

Serap A Aktas Yildirim, MD

Z

Zeynep Tugce Sarikaya, M.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SCREENING

Number of Arms

2

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Published Research Related To This Trial

Blood Pressure Management by Anesthesia Professionals: Evaluating Clinician Skill From Electronic Medical Records.

Daniel I Sessler, Mohammad Z Khan, Kamal Maheshwari...

https://pubmed.ncbi.nlm.nih.gov/33031346

Hypotension after Anesthesia Induction: Target-Controlled Infusion Versus Manual Anesthesia Induction of Propofol.

Serap Aktas Yildirim, Lerzan Dogan, Zeynep Tugce Sarikaya...

https://pubmed.ncbi.nlm.nih.gov/37629322