Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2017-03-01
2020-09-30
Brief Summary
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Detailed Description
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For more than two decades, the pharmacodynamic properties of remifentanil relied on Minto's model, which is based on processed EEG as the reference to quantify the analgesic effect and effect-site concentration estimate. This remifentanil pharmacodynamic was modeled under conditions administered to volunteers rapidly and at very high doses to induce substantial changes in the spontaneous processed EEG. The experimental concentrations and infusion rates are far from sedative levels, where the EEG has shown a clear response to hypnosis but not to analgesia or nociception.
Under the hypothesis that pharmacological models should predict equally well the effects induced by drugs at different concentrations levels, the purpose of this study is to evaluate and validate the pharmacodynamic predictions given by Minto's model in patients under conscious sedation using the algometry as a reference of nociception.
The study recruits 100 female patients scheduled for benign gynecological surgery divided into three groups. A group of 35 patients receives a constant TCI effect-site target infusion of 1.5 ng/ml of remifentanil for 25 min. The second group of 35 follow the same protocol with a bolus of 1 mg of midazolam before the remifentanil infusion. The rest configures the control group under saline solution.
Experimental data consist of basal algometry (pressure pain threshold) aside from BIS index, blood pressure, and heart rate values and at time-points of 1.5, 5, 10, 15, 18, 20, and 25 minutes after induction.
Minto's remifentanil pharmacodynamic model validation relies on comparing the levels and temporal evolution of the algometry measurements during the whole experiment concerning the effect-site estimations provided by the TCI-pump Minto's model.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group I TCI effect-site target infusion of 1.5 ng/ml of remifentanil
Group I of 35 patients received a constant TCI effect-site target infusion of 1.5 ng/ml of remifentanil for 25 min.
Remifentanil 1 MG Injection [Ultiva]
Group I TCI effect-site target infusion of 1.5 ng/ml of remifentanil.
Algometry
The algometry technique is used to assess the pain pressure threshold as an analgesic effect of remifentanil concerning Minto's model prediction.
Group II TCI effect-site target infusion of 1.5 ng/ml of remifentanil + 1 mg Midazolam iv
Group II of 35 patients received a constant TCI effect-site target infusion of 1.5 ng/ml of remifentanil for 25 min with a bolus of 1 mg of midazolam previous to the remifentanil infusion
Remifentanil 1 MG Injection [Ultiva]
Group I TCI effect-site target infusion of 1.5 ng/ml of remifentanil.
Midazolam 1 MG/ML Prefilled Syringe
Group II TCI effect-site target infusion of 1.5 ng/ml of remifentanil + 1 mg Midazolam iv
Algometry
The algometry technique is used to assess the pain pressure threshold as an analgesic effect of remifentanil concerning Minto's model prediction.
Group III Control
Group III of 30 patients. The same TCI system provided the saline solution in the control group under an equivalent simulation profile to the remifentanil administration
Saline solution
Group III Control
Algometry
The algometry technique is used to assess the pain pressure threshold as an analgesic effect of remifentanil concerning Minto's model prediction.
Interventions
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Remifentanil 1 MG Injection [Ultiva]
Group I TCI effect-site target infusion of 1.5 ng/ml of remifentanil.
Midazolam 1 MG/ML Prefilled Syringe
Group II TCI effect-site target infusion of 1.5 ng/ml of remifentanil + 1 mg Midazolam iv
Saline solution
Group III Control
Algometry
The algometry technique is used to assess the pain pressure threshold as an analgesic effect of remifentanil concerning Minto's model prediction.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18-80 years old
* ASA I-III
Exclusion Criteria
* Conduct disorder or anxiety-depressive syndrome
* Chronic treatment with psychotropic drugs or opiates
* Pregnancy
* Alcohol abuse
* Documented allergy to remifentanil or midazolam
* Refusal to participate in the study
18 Years
80 Years
FEMALE
Yes
Sponsors
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Hospital Universitari Vall d'Hebron Research Institute
OTHER
Responsible Party
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Principal Investigators
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Ana Abad-Torrent, M.D
Role: PRINCIPAL_INVESTIGATOR
University Vall d'Hebron Hospital
Locations
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Ana Abad-Torrent
Barcelona, , Spain
Countries
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Other Identifiers
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EPA (AG) 33/2017 (5097)
Identifier Type: -
Identifier Source: org_study_id