The PROTECT Trial: PROpofol Titration to Enhance haemodynamiC sTability
Recruiting now · Not applicable
Conditions studied: Anesthesia
In brief
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.
Key facts
- Study ID
- NCT06980688
- Run by
- University Hospital, Basel, Switzerland
- People needed
- 320
- Starts
- 2025-09-02
- Expected to finish
- 2027-09-01
- Last updated by the study team
- 2025-09-19
Who can join
Age: 55 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University Hospital Basel — Basel, Switzerland (enrolling)
- Kantonsspital Baden — Baden, Switzerland
- Cantonal Hospital Graubünden — Chur, Switzerland
- Kantonsspital Olten, soH — Olten, Switzerland
Full record on ClinicalTrials.gov
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