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RECRUITING
NCT06980688
NA

The PROTECT Trial: PROpofol Titration to Enhance haemodynamiC sTability

Sponsor: University Hospital, Basel, Switzerland

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

55 Years - Any

Study Type

INTERVENTIONAL

Enrollment

320

Start Date

2025-09-02

Completion Date

2027-09

Last Updated

2025-09-19

Healthy Volunteers

No

Conditions

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.

Locations (4)

Kantonsspital Baden

Baden, Switzerland

University Hospital Basel

Basel, Switzerland

Cantonal Hospital Graubünden

Chur, Switzerland

Kantonsspital Olten, soH

Olten, Switzerland