Remifentanil Effect on Burst Suppression Ratio
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Chile
About this trial
The goal of this clinical trial is to determine whether remifentanil has a facilitating effect on the generation of burst suppression by propofol in adult patients (18-60 years) candidates for elective surgery who require remifentanil and American Society of Anesthesiology (ASA) classification I or II. The main question it aims to answer are:
• To determine whether remifentanil has a facilitating effect on the generation of burst suppression by propofol.
Participants will undergo general anesthesia with remifentanil and propofol sequentially. After loss of consciousness, remifentanil will be adjusted to a medium or high concentration randomly and it will be determined at what concentration of propofol the burst suppressions are generated.
Then, the concentrations of propofol that generate burst suppression associated with either a medium or high concentration of remifentanil will be compared.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
American Society of Anesthesiology I or II
Elective surgery of low or intermediate risk
Disqualifiers
Neurological disease
Psychiatric disease
Use of psychoactive drugs or opioids
Altered basal state of consciousness
Trial design
Design model
Crossover
Treatments tested in this trial
High dose of remifentanil
DrugThe dose of remifentanil will be changed to determine the concentration of propofol at which burst suppressions are generated
Medium dose of remifentanil
DrugThe dose of remifentanil will be changed to determine the concentration of propofol at which burst suppressions are generated
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: High doseExperimental treatment 1 intervention
Group B: Medium doseActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Propofol estimated concentration by Marsh pharmacological model, which generates burst suppression
\[mcg/mL\]
Time frame
During 10 minutes when propofol dosification is increased to 15 mg/kg/hSecondary outcomes
1
Propofol estimated concentration by Marsh pharmacological model, which generates loss of consciousness
\[mcg/mL\]
Time frame
Minutes, during anesthesia induction is performed2
Mean arterial pressure during burst suppression
mmHg
Time frame
During 10 minutes when propofol dosification is increased to 15 mg/kg/h3
Total ephedrine dose
mg
Time frame
During all protocol, 40 min4
Maximal dose of norepinephrine
mcg/kg/min
Time frame
During all protocol, 40 minSponsors and contacts
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Source ClinicalTrials.gov