This trial is designed to quantify the pharmacodynamic (PD) and pharmacokinetic (PK) interaction(s) between an anaesthetic drug (remimazolam) and an opioid (remifentanil). Remimazolam is a new anaesthetic drug with a sedative effect, which, in combination with an opioid can be used to achieve general anaesthesia. To date, however, no clinical trials have been conducted to specifically assess the potential for drug-drug interactions between remimazolam and remifentanil. Greater understanding of the potential for such interactions will help define more appropriate dosing regimens with less over-sedation and associated side effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
28
Remimazolam is an intravenous anaesthetic and sedative drug. Remimazolam exhibits its anaesthetic effects via the benzodiazepine binding site at the GABAA receptor.
Remifentanil is a commonly used opioid in anaesthetic practice. It is a potent and fast-acting analgesic.
University Medical Center Groningen
Groningen, Netherlands
Exposure-response model describing the relationship between effect-site concentrations of remimazolam and plasma concentrations of remifentanil and MOAA/S corresponding to mild, moderate and deep sedation.
Time frame: Through study completion, approximately 3 weeks
Exposure-response model describing the relationship between effect-site concentrations of remimazolam and plasma concentrations of remifentanil and BIS corresponding to mild, moderate and deep sedation.
Time frame: Through study completion, approximately 3 weeks
Performance characteristics for the TCI models used (remimazolam and remifentanil) according to Varvel et al. These include median absolute performance error, median performance error, wobble and divergence.
Time frame: Through study completion, approximately 3 weeks
Exposure response models for tolerance to laryngoscopy
Time frame: Through study completion, approximately 3 weeks
Exposure response models for tolerance to tetanic stimulus
Time frame: Through study completion, approximately 3 weeks
Exposure response models for BIS
Time frame: Through study completion, approximately 3 weeks
Exposure response models for hemodynamic alterations in terms of heart rate, arterial blood pressure (ABP), mean arterial pressure (MAP), stroke volume and cardiac output
Time frame: Through study completion, approximately 3 weeks
Exposure response models for respiratory depression
Time frame: Through study completion, approximately 3 weeks
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