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To compare a new, painless way of administering intravenous propofol with the standard form

Analysis of the effectiveness of Non-painful Endovenous Management (MENA) in the administration of Propofol - Non-painful administration of propofol

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2018-001770-15-ES
Enrollment
200
Registered
2019-11-19
Start date
2020-01-24
Completion date
Unknown
Last updated
2020-02-01

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

Conditions

Propofol is used as an intravenous agent for induction and anesthetic maintenance. However, without any intervention before your administration, as is usually administered, the incidence of local pain after injection is close to 70%. We want to investigate another way to administer propofol and compare it with the usual way to know if we are able to avoid the pain caused by its administration

Interventions

Trade Name: Propofol Fresenius 10mg/ml Product Name: Propofol Fresenius Product Code: 62134 Pharmaceutical Form: Injection INN or Propos

Sponsors

Complejo Asistencial Universitario de León
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients of both sexes between 18 and 65 years of age Patients who are going to be anesthetized to undergo surgery with general anesthesia procedures in the Caule. Patients who give their informed consent to participate in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Having kidney or liver diseases Allergy or known intolerance to Propofol Allergy or known intolerance to Fentanyl Allergy or known intolerance to Lidocaine Inability to grant informed consent

Design outcomes

Primary

MeasureTime frame
Main Objective: To analyze the effectiveness of another form of endovenous management of propofol on the pain that may appear during its administration.</;Secondary Objective: Not applicable;Primary end point(s): Analyze if the patient feels pain after the administration of Propofol;Timepoint(s) of evaluation of this end point: During the administration of Propofol

Secondary

MeasureTime frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable

Countries

Spain

Contacts

Public ContactDepartametno Gastroenterologia

Complejo Asistencial de León

fjorqueraplaza@gmail.com34987237400229

Outcome results

None listed

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