The PROTECT Trial: PROpofol Titration to Enhance haemodynamiC sTability

NCT06980688 | Recruiting

• 1 other identifier: am24DellKuster
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Anesthesia

Keywords

Target-controlled infusion

Outcome Measures

Primary Outcomes (1)

• Area under the mean arterial pressure threshold (AUT)

  The area under the mean arterial pressure (MAP)-time curve below each patient's individual baseline MAP (AUT) is measured during the first 30 minutes after the start of anaesthesia induction.

  30 min after start of induction

Secondary Outcomes (15)

• Maximum Deviance (maxDev)

  30 min after start of induction

• Use of vasoactive drugs

  Up to 30 min after start of induction

• Use of Trendelenburg/ lithotomy positioning

  Up to 30 min after start of induction

• Total propofol consumption

  At LOC, up to 30 min after start of induction, and at skin incision

• Neurocognitive test

  before surgery, 1 and 3-5 hours after recovery of consciousness (ROC)

Other Outcomes (1)

• Health Economic Analysis

  During the perioperative period

Study Arms (2)

Titration group

EXPERIMENTAL

Patients in the titration group undergo anaesthesia induction using a stepwise approach, where the target effect-site concentration (Cet) of propofol is incrementally increased until loss of consciousness (LOC) is achieved. Once LOC is reached, the remifentanil target concentration is elevated to mitigate the laryngeal stimulus to intubation.

Procedure: Propofol titration

Conventional group

OTHER

Patients in the conventional group receive anaesthesia induction using a predefined high Cet of propofol, set above the typical level required to achieve loss of consciousness (LOC), aiming for rapid induction. After induction, the remifentanil target concentration is adjusted to mitigate the laryngeal stimulus of intubation.

Procedure: Conventional propofol induction

Interventions

Propofol titration PROCEDURE

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.

Titration group

Conventional propofol induction PROCEDURE

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

Conventional group

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify 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 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• University of Basel: collaborator
• University of Zurich: collaborator

Study Sites (4)

Kantonsspital Baden

Baden, 5404, Switzerland

NOT YET RECRUITING

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

Cantonal Hospital Graubünden

Chur, 7000, Switzerland

NOT YET RECRUITING

Kantonsspital Olten, soH

Olten, 4600, Switzerland

NOT YET RECRUITING

Related Publications (1)

• Funk S, Lohri MD, Kopp Lugli A, Schindler C, Wiencierz A, Mnich K, Schlapfer M, Gaberdiel AP, Puhan MA, Steiner LA, Gomes NV, Dell-Kuster S. The PROTECT trial: Effect of titrated versus conventional induction of general anaesthesia using a target-controlled infusion system on haemodynamics in patients undergoing non-cardiac surgery - protocol for a multicentre, expertise-based randomised controlled trial. BMJ Open. 2026 Jan 28;16(1):e110452. doi: 10.1136/bmjopen-2025-110452.

  PMID: 41605589 DERIVED

Study Officials

• Salome Dell-Kuster, Prof. Dr. med

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Lohri, Dr. med.

CONTACT

+41 61 556 52 27; martindominik.lohri@usb.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 20, 2025
• Study Start: September 2, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: After publication of the data, 20 years

Locations

CH (4)