The PROTECT Trial: PROpofol Titration to Enhance haemodynamiC sTability (NCT06980688) | Clinical Trial Compass
RecruitingNot Applicable
The PROTECT Trial: PROpofol Titration to Enhance haemodynamiC sTability
Switzerland320 participantsStarted 2025-09-02
Plain-language summary
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.
Who can participate
Age range55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 p…
What they're measuring
1
Area under the mean arterial pressure threshold (AUT)