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Recruiting NCT06980688

The PROTECT Trial: PROpofol Titration to Enhance haemodynamiC sTability

No phase Interventional Anesthesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Propofol titration, Conventional propofol induction.
Who it may be relevant to
Registry conditions: Anesthesia. Basic parameters: from 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Multicentre Single-blinded, Expertise-based RCT Comparing Haemodynamic Parameters Between Titration and Conventional Induction of General Anaesthesia With Target-controlled Infusion System in Patients Undergoing Non-cardiac Surgery

Overview

The aim of this multicentre, single-blinded, expertise-based randomised controlled trial is evaluate whether slowly increasing the dose of the anaesthetic drug propofol based on a patient's needs leads to more stable blood pressure compared to giving a standard starting dose in patients aged 55 and older undergoing non-cardiac surgery.

Detailed description

Propofol is a widely used anaesthetic drug known to lower blood pressure (hypotension) by relaxing blood vessels. The extent of hypotension depends on the dose and speed of propofol administration. A significant drop in blood pressure after anaesthesia is started, known as post-induction hypotension (PIH), can damage organs like the heart and kidneys, especially in older and multimorbid patients.

Target-controlled infusion (TCI) systems are commonly used to deliver anaesthetic drugs like propofol and remifentanil in a controlled way. The standard approach for starting anaesthesia (induction) is to begin with a high dose to quickly make the patient unconscious and suppress the body's response to intubation. Titration is a potentially safer alternative, where the dose is slowly increased until the patient becomes unconscious.

However, current evidence comparing the two methods is limited, especially in older patients. A small retrospective study suggested that titration improves blood pressure stability, and a survey of Swiss anaesthetists showed strong interest in this approach.

This multicentre, single-blinded, expertise-based randomised controlled trial investigates whether titration using TCI systems improves blood pressure stability in patients aged 55 and older undergoing non-cardiac surgery. The results of this trial will help to evaluate the clinical applicability and economic impact of the titration method in routine anaesthesia care and may support its future implementation into standard practice.

Interventions

  • Procedure Propofol titration
    Induction starts with propofol target-controlled Infusion (TCI) (Schnider model) at target effect-site drug concentration (Cet) 0.5-1.0 µg/mL and remifentanil TCI (Minto model) at Cet 0.5 ng/mL. If loss of consciousness (LOC) is not reached, propofol Cet is increased in 0.5-1.0 µg/mL steps. For intubation, remifentanil Cet increases up to 6.0 ng/mL.
  • Procedure Conventional propofol induction
    Induction starts with propofol TCI at Cet 4-8 µg/mL and remifentanil TCI at Cet 2.5-3.5 ng/mL.

Primary outcome measures

  • Area under the mean arterial pressure threshold (AUT) [Time frame: 30 min after start of induction]
Secondary outcome measures (12)
  • Maximum Deviance (maxDev) [Time frame: 30 min after start of induction]
  • Use of vasoactive drugs [Time frame: Up to 30 min after start of induction]
  • Use of Trendelenburg/ lithotomy positioning [Time frame: Up to 30 min after start of induction]
  • Total propofol consumption [Time frame: At LOC, up to 30 min after start of induction, and at skin incision]
  • Neurocognitive test [Time frame: before surgery, 1 and 3-5 hours after recovery of consciousness (ROC)]
  • Brice Interview [Time frame: 3-5 hours after ROC]
  • Time from induction start to LOC [Time frame: From induction start to LOC]
  • Total remifentanil consumption [Time frame: At LOC, up to 30 min after start of induction, and at skin incision]
  • Time from induction start to intubation [Time frame: From induction start to intubation]
  • Signs of reaction to intubation [Time frame: During intubation]
  • Effect-site concentration of propofol [Time frame: At LOC and ROC]
  • Effect-site concentration (Ce) of remifentanil [Time frame: At LOC and ROC]

Eligibility criteria

Inclusion criteria

  • Adults ≥ 55 years old
  • Patients undergoing any of the following planned surgery under general anaesthesia with intubation: Ear, nose and throat, gynaecological, maxillofacial, orthopedic, plastic and reconstructive, spine, urologic, vascular (varicose vein surgery, femoral endarterectomy, peripheral bypass surgery) and visceral surgery
  • Standard procedure for anaesthesia with propofol Target-Controlled Infusion (TCI) using the Schnider model and remifentanil TCI using the Minto model
  • American Society of Anesthesiologists Physical Status Classification system (ASA PS) I-IV
  • Body mass index (BMI) ≥18.5 or <35 kg/m2
  • Signed written informed consent

Exclusion criteria

  • Special forms of anaesthesia induction, specifically awake tracheal intubation and rapid sequence induction
  • Combined anaesthesia procedures (general and regional anaesthesia combined)
  • Special forms of general anaesthesia (opioid-free anaesthesia or any opioid-sparring modifications with lidocaine, magnesium, ketamine, clonidine or dexmedetomidine)
  • Surgery in the prone position within the first 30 minutes
  • Patients with known difficult airway
  • Daily consumption of alcohol (> one unit/day) or > seven units/week
  • Any regular recreational drug abuse
  • Chronic use of benzodiazepines or opioids
  • Allergy to propofol
  • Patients with known brain pathologies, specifically seizure disorders, stroke within the past 9 months or dementia
  • History of awareness
  • Inability to follow procedures or insufficient knowledge in German

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Switzerland · 4 centers
  • Kantonsspital Baden — Baden
  • University Hospital Basel — Basel
  • Cantonal Hospital Graubünden — Chur
  • Kantonsspital Olten, soH — Olten

Publications

  • Funk S, Lohri MD, Kopp Lugli A, Schindler C, Wiencierz A, Mnich K, Schlapfer M, Gaberdiel AP, Puhan MA, Steiner LA, Gomes NV, Dell-Kuster S. The PROTECT trial: Effect of titrated versus conventional induction of general anaesthesia using a target-controlled infusion system on haemodynamics in patients undergoing non-cardiac surgery - protocol for a multicentre, expertise-based randomised controlle PMID 41605589

Identifiers

NCT: NCT06980688 · am24DellKuster

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗