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Clinical comparison between two propofol pumps for general anaesthesia

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN41934206
Enrollment
78
Registered
2022-10-25
Start date
2022-10-30
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General anaesthesia Surgery

Interventions

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)

Sponsors

Azienda ULSS 2 Treviso
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Women undergoing general anesthesia with TIVA-TCI for breast surgery

Exclusion criteria

Exclusion criteria: 1. Patients with any neurologic/respiratory/liver/kidney diseases 2. Patients taking any psychiatric drugs, including benzodiazepines

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Measured during the procedure measured using EEG: 1. Episodes of deepening anesthesia (BIS 60) 3. Burst suppression 4. Unwanted spontaneous responsiveness

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026