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| Name | Class |
|---|---|
| University of Basel | OTHER |
| University of Zurich | OTHER |
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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.
Propofol is a widely used anaesthetic drug known to lower blood pressure (hypotension) by relaxing blood vessels. The extent of hypotension depends on the dose and speed of propofol administration. A significant drop in blood pressure after anaesthesia is started, known as post-induction hypotension (PIH), can damage organs like the heart and kidneys, especially in older and multimorbid patients.
Target-controlled infusion (TCI) systems are commonly used to deliver anaesthetic drugs like propofol and remifentanil in a controlled way. The standard approach for starting anaesthesia (induction) is to begin with a high dose to quickly make the patient unconscious and suppress the body's response to intubation. Titration is a potentially safer alternative, where the dose is slowly increased until the patient becomes unconscious.
However, current evidence comparing the two methods is limited, especially in older patients. A small retrospective study suggested that titration improves blood pressure stability, and a survey of Swiss anaesthetists showed strong interest in this approach.
This multicentre, single-blinded, expertise-based randomised controlled trial investigates whether titration using TCI systems improves blood pressure stability in patients aged 55 and older undergoing non-cardiac surgery. The results of this trial will help to evaluate the clinical applicability and economic impact of the titration method in routine anaesthesia care and may support its future implementation into standard practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Deviance (maxDev) | The maximum deviation between baseline MAP and the lowest recorded MAP (maxDev) is measured during the first 30 minutes after the start of anaesthesia induction. | 30 min after start of induction |
| Use of vasoactive drugs |
| Measure | Description | Time Frame |
|---|---|---|
| Health Economic Analysis | This outcome focuses on the health economic analysis of the perioperative period, assessing several key cost-related metrics. These include the amount of propofol and other anaesthesia drugs used, operating theatre and PACU occupation times, staff time, and length of stay (overall and by ward type). Additionally, perioperative costs, from the hospital's perspective, are evaluated both overall and broken down by category, as well as hospitalisation costs. The aggregation of these measures will provide a comprehensive health economic outcome, reflecting the total resource utilization and associated costs in the perioperative period. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martin Lohri, Dr. med. | Contact | +41 61 556 52 27 | martindominik.lohri@usb.ch |
| Name | Affiliation | Role |
|---|---|---|
| Salome Dell-Kuster, Prof. Dr. med | University Hospital, Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital Baden | Not yet recruiting | Baden | 5404 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41605589 | Derived | 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. |
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Anonymised data upon reasonable request
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After publication of the data, 20 years
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| 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. |
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The administration of vasoactive drugs during the first 30 minutes following the start of anaesthesia induction is documented.
| Up to 30 min after start of induction |
| Use of Trendelenburg/ lithotomy positioning | The application of Trendelenburg/lithotomy positioning, where the patient is laid flat with the legs elevated above the head during the first 30 minutes following the start of anaesthesia induction is documented. If applied, the duration of this positioning is recorded. | Up to 30 min after start of induction |
| Total propofol consumption | Total propofol consumption in mg/kg is assessed at loss of consciousness (LOC), during the first 30 minutes after the start of anaesthesia induction, and at skin incision. | At LOC, up to 30 min after start of induction, and at skin incision |
| Neurocognitive test | To assess changes in neurocognitive performance, the validated, computerised Creyos task battery is used. Changes from baseline are used to evaluate the short-term impact of anaesthesia induction method on postoperative cognition. | before surgery, 1 and 3-5 hours after recovery of consciousness (ROC) |
| Brice Interview | To evaluate the occurrence of intraoperative awareness, the the structured and validated Brice interview is conducted postoperatively. | 3-5 hours after ROC |
| Time from induction start to LOC | The time from the start of anaesthesia induction to the onset of LOC is measured. LOC is defined by the absence of response to verbal and tactile stimuli, loss of the eyelash reflex, and no reaction to a jaw thrust manoeuvre. The time to LOC will be recorded to assess the speed of induction between different anaesthesia techniques. | From induction start to LOC |
| Total remifentanil consumption | Total remifentanil consumption in ug/kg is assessed at LOC, during the first 30 minutes after the start of anaesthesia induction, and at skin incision. | At LOC, up to 30 min after start of induction, and at skin incision |
| Time from induction start to intubation | The time from the start of anaesthesia induction to successful intubation is measured. | From induction start to intubation |
| Signs of reaction to intubation | The occurrence of signs of reaction to intubation are recorded as yes/no. If a reaction is noted, the specific signs will be documented in free text, including but not limited to tachycardia, cough reflex, limb movement, or eye opening. This outcome will help evaluate the anaesthesia technique's ability to suppress intubation responses. | During intubation |
| Effect-site concentration of propofol | The effect-site concentration (Ce) of propofol is measured at LOC and ROC. | At LOC and ROC |
| Effect-site concentration (Ce) of remifentanil | The effect-site concentration (Ce) of remifentanil is measured at LOC and ROC. | At LOC and ROC |
| Duration of MAP below threshold | The time that the MAP remains below 70 mmHg and 60 mmHg during the first 30 minutes following the start of anaesthesia induction is recorded. | Up to 30 min after start of induction |
| Bispectral Index at skin incision | The Bispectral Index (BIS) value at the time of skin incision as a measure of the patient's level of consciousness is recorded. | At skin incision |
| Total opioid consumption | The total opioid consumption during the post-anaesthesia care unit (PACU) stay is recorded. | During PACU stay |
| During the perioperative period |
| University Hospital Basel | Recruiting | Basel | 4031 | Switzerland |
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| Cantonal Hospital Graubünden | Not yet recruiting | Chur | 7000 | Switzerland |
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| Kantonsspital Olten, soH | Not yet recruiting | Olten | 4600 | Switzerland |
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