RecruitingNot ApplicableNCT06980688

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

Sponsor

University Hospital, Basel, Switzerland

Enrollment

320 participants

Start Date

Sep 2, 2025

Study Type

INTERVENTIONAL

Conditions

Anesthesia

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 leads to more stable blood pressure compared to giving a standard starting dose in patients aged 55 and older undergoing non-cardiac surgery.

Eligibility

Min Age: 55 Years

Inclusion Criteria6

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 Criteria12

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

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Interventions

PROCEDUREPropofol titration

Induction starts with propofol target-controlled Infusion (TCI) (Schnider model) at target effect-site drug concentration (Cet) 0.5-1.0 µg/mL and remifentanil TCI (Minto model) at Cet 0.5 ng/mL. If loss of consciousness (LOC) is not reached, propofol Cet is increased in 0.5-1.0 µg/mL steps. For intubation, remifentanil Cet increases up to 6.0 ng/mL.

PROCEDUREConventional propofol induction

Induction starts with propofol TCI at Cet 4-8 µg/mL and remifentanil TCI at Cet 2.5-3.5 ng/mL.