The PROTECT Trial: PROpofol Titration to Enhance haemodynamiC sTability
NCT06980688 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 320
Last updated 2025-09-19
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
Interventions
- PROCEDURE
-
Propofol 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.
- PROCEDURE
-
Conventional propofol induction
Induction starts with propofol TCI at Cet 4-8 µg/mL and remifentanil TCI at Cet 2.5-3.5 ng/mL.
Sponsors & Collaborators
-
University of Basel
collaborator OTHER -
University of Zurich
collaborator OTHER -
University Hospital, Basel, Switzerland
lead OTHER
Principal Investigators
-
Salome Dell-Kuster, Prof. Dr. med · University Hospital, Basel, Switzerland
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-02
- Primary Completion
- 2027-09-30
- Completion
- 2027-09-30
Countries
- Switzerland
Study Locations
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