PROTECT Trial: Effect of the anesthetic drug propofol on blood pressure during the induction of general anesthesia: Does a gradual increase in propofol lead to a smaller drop in blood pressure compared to a single dose of a calculated standard propofol dose?
Zusammenfassung der Studie
An anesthesia approach tailored to the patient is the goal of the anesthesia team. In addition to continuous monitoring of the heart, circulation, and breathing, the optimal dosing of all anesthetic drugs is also important. The induction dose of propofol is individually calculated and administered based on certain characteristics such as body size, weight, age, and possible comorbidities of the patients. Typically, this calculated induction dose of anesthesia is administered via a single intravenous dose. In another approach, the actual induction dose needed by the individual patient is determined stepwise by gradually increasing the dosage. It starts with a lower dosage and is increased until the patient is asleep. Regardless of the method used for the induction dose, the propofol dosage is continuously adjusted by anesthesia professionals according to the needs of the patients after they are asleep. Both procedures are already used in routine practice. The aim of the study is to investigate whether a stepwise administration of the anesthetic drug propofol is associated with a less pronounced drop in blood pressure. It will also be determined whether the stepwise administration is associated with improved recovery of the patients after anesthesia. Furthermore, it should be shown that the induction of anesthesia using gradual dosing requires overall lower doses of propofol and fewer blood pressure-supporting medications compared to the administration of a single dose of propofol. Patients participating in this study will be randomly treated with one of the two aforementioned anesthesia methods. The patient will not know which method is being applied.
(BASEC)
Untersuchte Intervention
The anesthetic drug propofol, which is most commonly used for general anesthesia, often causes a drop in blood pressure as a side effect. With our research project, we want to find out how propofol can be optimally administered at the start of anesthesia (induction of anesthesia) in a dosage tailored to the patient (as little as possible, as much as necessary), so that:
• Fewer drops in blood pressure occur
• Fewer blood pressure-supporting medications are needed
• A lower medication dose of the anesthetic drug propofol is required
• The recovery of brain functions occurs more quickly
(BASEC)
Untersuchte Krankheit(en)
Two different standard dosing methods in general anesthesia are being compared
(BASEC)
- Patients ≥ 55 years, thus excluding women of childbearing age - Planned procedures in the fields of ENT (ear, nose, and throat medicine), gynecology, orthopedics, urology, oral, jaw, and facial surgery, plastic and reconstructive surgery, spinal surgery, vascular surgery, and abdominal surgery - BMI ≥ 18.5 or < 35 kg/m2 (BASEC)
Ausschlusskriterien
- Special forms of anesthesia induction - Combined anesthesia procedures (general anesthesia and local anesthesia) - Patients who have already received medications before the medical procedure (BASEC)
Studienstandort
Basel, Chur, Andere
(BASEC)
Baden, Olten
(BASEC)
Sponsor
Universitätsspital Basel
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Dr. med. Martin Dominik Lohri
+41 61 556 52 27
martin.lohri@clutterusb.chUniversitätsspital Basel
(BASEC)
Allgemeine Auskünfte
University Hospital, Basel, Switzerland
+41 61 556 52 27
martin.lohri@clutterusb.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
27.06.2025
(BASEC)
ICTRP Studien-ID
NCT06980688 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
The PROTECT Trial: PROpofol Titration to Enhance haemodynamiC sTability 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 (BASEC)
Wissenschaftlicher Titel
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 (ICTRP)
Öffentlicher Titel
The PROTECT Trial: PROpofol Titration to Enhance haemodynamiC sTability (ICTRP)
Untersuchte Krankheit(en)
Anesthesia (ICTRP)
Untersuchte Intervention
Procedure: Propofol titrationProcedure: Conventional propofol induction (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Single (Participant). (ICTRP)
Ein-/Ausschlusskriterien
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 (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Area under the mean arterial pressure threshold (AUT) (ICTRP)
Maximum Deviance (maxDev);Use of vasoactive drugs;Use of Trendelenburg/ lithotomy positioning;Total propofol consumption;Neurocognitive test;Brice Interview;Time from induction start to LOC;Total remifentanil consumption;Time from induction start to intubation;Signs of reaction to intubation;Effect-site concentration of propofol;Effect-site concentration (Ce) of remifentanil;Duration of MAP below threshold;Bispectral Index at skin incision;Total opioid consumption (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
University of Basel;University of Zurich (ICTRP)
Weitere Kontakte
Salome Dell-Kuster, Prof. Dr. medMartin Lohri, Dr. med., martindominik.lohri@usb.ch, +41 61 556 52 27, University Hospital, Basel, Switzerland (ICTRP)
Sekundäre IDs
am24DellKuster (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06980688 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar