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New treatment option for Anesthesia
Official title The PROTECT Trial: PROpofol Titration to Enhance haemodynamiC sTability
ClinicalTrials.gov ID: NCT06980688
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 and older
You may be able to join if
- Adults ≥ 55 years old
- Patients undergoing any of the following planned surgery under general anaesthesia with intubation: Ear, nose and throat, gynaecological...
- 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
You likely can't join 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...
- 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
See the full eligibility 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Baden, Switzerland
- Basel, Switzerland
- Chur, Switzerland
- Olten, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baden, Switzerland; Basel, Switzerland; Chur, Switzerland; Olten, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.