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?
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
- Special forms of anesthesia induction - Combined anesthesia procedures (general anesthesia and local anesthesia) - Patients who have already received medications before the medical procedure (BASEC)
Luogo dello studio
Basilea, Chur, Altro
(BASEC)
Baden, Olten
(BASEC)
Sponsor
Universitätsspital Basel
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Dr. med. Martin Dominik Lohri
+41 61 556 52 27
martin.lohri@clutterusb.chUniversitätsspital Basel
(BASEC)
Informazioni generali
University Hospital, Basel, Switzerland
+41 61 556 52 27
martin.lohri@clutterusb.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
27.06.2025
(BASEC)
ID di studio ICTRP
NCT06980688 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
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)
Titolo accademico
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)
Titolo pubblico
The PROTECT Trial: PROpofol Titration to Enhance haemodynamiC sTability (ICTRP)
Malattie studiate
Anesthesia (ICTRP)
Intervento studiato
Procedure: Propofol titrationProcedure: Conventional propofol induction (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Single (Participant). (ICTRP)
Criteri di inclusione/esclusione
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)
non disponibile
Endpoint primari e secondari
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)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
University of Basel;University of Zurich (ICTRP)
Contatti aggiuntivi
Salome Dell-Kuster, Prof. Dr. medMartin Lohri, Dr. med., martindominik.lohri@usb.ch, +41 61 556 52 27, University Hospital, Basel, Switzerland (ICTRP)
ID secondari
am24DellKuster (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06980688 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile