To compare a new, painless way of administering intravenous propofol with the standard form
Phase 1
- 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 administrationTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2018-001770-15-ES
- Lead Sponsor
- Complejo Asistencial Universitario de León
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 200
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable