Status:
RECRUITING
The PROTECT Trial: PROpofol Titration to Enhance haemodynamiC sTability
Lead Sponsor:
University Hospital, Basel, Switzerland
Collaborating Sponsors:
University of Basel
University of Zurich
Conditions:
Anesthesia
Eligibility:
All Genders
55+ years
Phase:
NA
Brief 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 lead...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT06980688
Start Date
September 2 2025
End Date
September 1 2027
Last Update
September 19 2025
Active Locations (4)
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1
Kantonsspital Baden
Baden, Switzerland, 5404
2
University Hospital Basel
Basel, Switzerland, 4031
3
Cantonal Hospital Graubünden
Chur, Switzerland, 7000
4
Kantonsspital Olten, soH
Olten, Switzerland, 4600