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Remifentanil Effect-site Prediction by Algometry

NCT05115578 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2021-11-10

No results posted yet for this study

Summary

This study validates the pharmacodynamic analgesic predictions (effect) given by Minto's remifentanil pharmacokinetic and dynamic model in conscious sedation. This standard model is based on the electroencephalogram (EEG) changes induced by this opioid as a proxy for describing the remifentanil analgesic effect, which might be only valid for high concentrations. Validation of the standard remifentanil model for low concentrations under sedation is needed for safer remifentanil administration.

Conditions

  • Conscious Sedation Failure During Procedure

Interventions

DRUG

Remifentanil 1 MG Injection [Ultiva]

Group I TCI effect-site target infusion of 1.5 ng/ml of remifentanil.

DRUG

Midazolam 1 MG/ML Prefilled Syringe

Group II TCI effect-site target infusion of 1.5 ng/ml of remifentanil + 1 mg Midazolam iv

DRUG

Saline solution

Group III Control

DEVICE

Algometry

The algometry technique is used to assess the pain pressure threshold as an analgesic effect of remifentanil concerning Minto's model prediction.

Sponsors & Collaborators

  • Hospital Universitari Vall d'Hebron Research Institute

    lead OTHER

Principal Investigators

  • Ana Abad-Torrent, M.D · University Vall d'Hebron Hospital

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2020-05-15
Completion
2020-09-30
FDA Drug
Yes

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05115578 on ClinicalTrials.gov