Clinical comparison between two propofol pumps for general anaesthesia
| ISRCTN | ISRCTN41934206 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41934206 |
| Secondary identifying numbers | 280922 |
- Submission date
- 30/09/2022
- Registration date
- 25/10/2022
- Last edited
- 18/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English Summary
Background and study aims
General anaesthesia can be delivered by intravenous drugs such as Propofol. In recent years various methods have been proposed to estimate the concentration in blood and at the brain (effector site) of this drug, utilizing pharmacokinetic and pharmacodynamic calculations. Eleveld and Schnider model are 2 of the Propofol model most commonly used in the clinical practice to deliver Propofol for general anaesthesia, however, their accuracy in predicting concentrations are different. The aim of this study is to evaluate if there are differences in estimating concentrations at loss of consciousness, return of consciousness and during general anaesthesia, as well as to compare if superificliazation or deepening events incidence is different between the 2 models, during Bispectral Index guided anesthesia.
Who can participate?
Adult women undergoing general anesthesia with TCI, undergoing breast surgery.
What does the study involve?
The procedure will proceed as usual, using TCI pumps with Eleveld and Schnider models
What are the possible benefits and risks of participating?
None
Where is the study run from?
Azienda ULSS 2 Treviso (Italy)
When is the study starting and how long is it expected to run for?
October 2022 to December 2022
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Linassi Federico, federico.linassi@aulss2.venero.it
Contact information
Principal Investigator
Piazza Ospedale 1
Treviso
31100
Italy
| Phone | +39 (0)422322410 |
|---|---|
| Federico.linassi@aulss2.Veneto.it |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | No participant information sheet available |
| Scientific title | Schnider versus Eleveld propofol target controller infusion model: a clinical comparison evaluating concentration at the effector site of propofol at loss of responsiveness during anesthesia maintenance and return of responsiveness |
| Study hypothesis | During recent years Eleveld and colleagues ideated a new propofol pharmacokinetic/pharmacodynamic (PK/PD) model for total intravenous anaesthesia with target controlled infusion (TIVA-TCI) pumps that has been proposed to have slightly better predictive performance for measured propofol plasma concentrations compared with those of the Marsh and Schnider models, and suitable for children, adults, older subjects, and obese adults, being considered as a “General purpose” model. However, no trials have compared the Eleveld to the Schnider model from a clinical point of view; so, this study aimed to compare the estimated effector site concentration of the two models (CePE and CePS, respectively) at loss of responsiveness (LoR), during anaesthesia maintenance (Bispectral Index [BIS] 40-60) and return of responsiveness (RoR). The study also compared the incidence of deepening or superficializing anaesthesia (defined respectively as lowering or increasing in out-of-target BIS after initial CeP detection), as well as unwanted anaesthesia events: burst suppression (BSupp, identified as a burst suppression ratio [BSR] >0) and unwanted spontaneous responsiveness. |
| Ethics approval(s) | Approved 20/01/2022, comitato etico di Treviso-Marca trevigiana (ospedale va Foncello, piazza ospedale 1, Treviso, Italy; +39 422328306; nrcaulss9@aulss2.Veneto.it), ref: 681/CE |
| Condition | General anaesthesia |
| Intervention | This study will enrol 78 patients who are undergoing breast oncologic surgery. Estimating the mean and standard deviation (SD) from the median and range of the Median Absolute Performance Error (MAPE) between the Eleveld PK-PD model and the Schnider PK-PD model in adults, the sample size was based on the following assumptions: a significant MAPE difference of 4% between the Eleveld PK-PD model and the Schnider PK-PD model in adults, an SD of 6.3%, type I error equal to 0.05, and type II error equal to 0.2 (power [1-β] = 0.8). Considering these assumptions, the sample size was calculated as 78 patients, equally divided between the Eleveld PK-PD model group (39 patients) and the Schnider PK-PD model group (39 patients). Induction and maintenance of anaesthesia were performed with TIVA-TCI. CeP and Ce of remifentanil (CeR) were achieved using the uSP6000 syringe pump infusion system (Arcomed ag, Steineckerstrasse 29 CH-8302 Kloten (Switzerland) using the Schnider or Eleveld model for Propofol, and Minto for remifentanil. After standard vital parameters monitoring including also Bispectral Index (BIS) using an XP monitor (Monitor BIS Module A-2000 Revision 3.12) with a bilateral electrode BIS (Covidien IIC, 15 Hampshire Street, Mansfield, MA 02048 USA) on the forehead of the patient, induction was started according to our hospital protocol, setting a CeP target of 0.5 μg ml-1, with increments of 0.5 μg ml-1 intervals when the estimated CeP equilibrated with target CeP. CeR was settled at 0.8 ng ml-1 until LoR (defined as loss of responsiveness to verbal commands), when both CeP and CeR were placed at 3 μg ml-1 and 3 ng ml-1, respectively. Then, a laryngeal mask Airways (LMA) was placed. During anaesthesia maintenance, CeP was adjusted to a target BIS of 40–604 by changes of 0.5 μg/ml at intervals of ≥1 min until BIS returned to the suggested range. The initial CeP during maintenance was defined as the CeP reached after a stable BIS for >10 minutes without CeP target changes. According to the protocol, if during maintenance the patient manifested any out-of-target BIS, the researchers set a new target concentration that, once the BIS returns in range for >10 minutes, was registered as final CeP. At the end of surgery, TIVA-TCI was targeted to a CeP of 0 μg/ml and a CeR of 0 ng/ml. With the return of spontaneous ventilation at RoR, defined as spontaneous eye-opening and execution of simple commands, the LMA was removed. |
| Intervention type | Other |
| Primary outcome measure | 1. Concentration of propofol at loss of consciousness, return of consciousness and during maintenance measured using the display on the equipment 2. Occurrence of deep or light anesthesia during the procedure measured using EEG |
| Secondary outcome measures | Measured during the procedure measured using EEG: 1. Episodes of deepening anesthesia (BIS <40) 2. Superficializing anesthesia (BIS >60) 3. Burst suppression 4. Unwanted spontaneous responsiveness |
| Overall study start date | 20/01/2022 |
| Overall study end date | 25/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 78 |
| Participant inclusion criteria | Women undergoing general anesthesia with TIVA-TCI for breast surgery |
| Participant exclusion criteria | 1. Patients with any neurologic/respiratory/liver/kidney diseases 2. Patients taking any psychiatric drugs, including benzodiazepines |
| Recruitment start date | 30/10/2022 |
| Recruitment end date | 25/12/2022 |
Locations
Countries of recruitment
- Italy
Study participating centre
Treviso
31100
Italy
Sponsor information
Hospital/treatment centre
Piazzale ospedale 1
Treviso
31100
Italy
| Phone | +39 (0)422322410 |
|---|---|
| paolo.zanatta1@aulss2.Veneto.it | |
| Website | https://www.aulss2.veneto.it/home |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. Federico.linassi@aulss2.veneto.it |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 16/10/2023 | 18/11/2024 | Yes | No |
Editorial Notes
18/11/2024: Publication reference added.
08/11/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/10/2022 to 25/12/2022.
2. The overall trial end date was changed from 30/10/2022 to 25/12/2022.
3. The intention to publish date was changed from 15/11/2022 to 31/12/2022.
07/11/2022: Internal review.
05/10/2022: Trial's existence confirmed by comitato etico di Treviso-Marca trevigiana
