Propofol titration to improve blood pressure stability during anaesthesia
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
NA · University Hospital, Basel, Switzerland · NCT06980688
For patients 55 and older having non-cardiac surgery, this will try slowly increasing propofol with a target-controlled infusion to see if blood pressure stays more stable than with the usual starting dose.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland (other) |
| Locations | 4 sites (Baden and 3 other locations) |
| Trial ID | NCT06980688 on ClinicalTrials.gov |
What this trial studies
Propofol commonly causes drops in blood pressure after anaesthesia induction, which can harm organs in older or multimorbid patients. This multicentre, single-blinded, expertise-based randomized trial compares a slow, need-based titration using propofol target-controlled infusion (Schnider model) with conventional induction dosing (with remifentanil TCI using the Minto model) in patients aged 55 and older undergoing planned non-cardiac surgery. The primary focus is on blood pressure stability and post-induction hypotension, with secondary analyses of clinical applicability and potential economic impact. Participating centres are in Switzerland and the trial uses standard perioperative monitoring and protocols across sites.
Who should consider this trial
Good fit: Adults aged 55 years and older scheduled for planned non-cardiac surgery under general anaesthesia with intubation using propofol and remifentanil target‑controlled infusion (Schnider and Minto models), ASA I–IV, and BMI 18.5–<35 kg/m2 are ideal candidates.
Not a fit: Patients requiring awake or rapid‑sequence intubation, combined general and regional anaesthesia, opioid‑free or modified opioid‑sparing techniques, those not managed with propofol/remifentanil TCI, emergency cases, or those outside the age/BMI criteria are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, titrated propofol induction could reduce episodes of post‑induction hypotension and lower the risk of organ injury and complications in older surgical patients.
How similar studies have performed: Existing evidence is limited: a small retrospective study suggested titration may improve blood pressure stability and surveys show clinician interest, but randomized data in older patients are sparse.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Baden and 3 other locations
- Kantonsspital Baden — Baden, Switzerland (NOT_YET_RECRUITING)
- University Hospital Basel — Basel, Switzerland (RECRUITING)
- Cantonal Hospital Graubünden — Chur, Switzerland (NOT_YET_RECRUITING)
- Kantonsspital Olten, soH — Olten, Switzerland (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Salome Dell-Kuster, Prof. Dr. med — University Hospital, Basel, Switzerland
- Study coordinator: Martin Lohri, Dr. med.
- Email: martindominik.lohri@usb.ch
- Phone: +41 61 556 52 27
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anesthesia, Target-controlled infusion