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Assessment of the Pharmacodynamic and Pharmacokinetic Interaction of Remimazolam and Remifentanil

NCT04670471 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2023-09-11

No results posted yet for this study

Summary

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.

Conditions

  • Anesthesia

Interventions

DRUG

Remimazolam

Remimazolam is an intravenous anaesthetic and sedative drug. Remimazolam exhibits its anaesthetic effects via the benzodiazepine binding site at the GABAA receptor.

DRUG

Remifentanil

Remifentanil is a commonly used opioid in anaesthetic practice. It is a potent and fast-acting analgesic.

Sponsors & Collaborators

  • University Medical Center Groningen

    collaborator OTHER

  • QPS Holdings LLC

    collaborator INDUSTRY

  • Paion UK Ltd.

    lead INDUSTRY

Principal Investigators

  • Remco Vellinga, MD · University Medical Center Groningen (UMCG)

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-13
Primary Completion
2022-01-28
Completion
2022-01-28

Countries

  • Netherlands

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 NCT04670471 on ClinicalTrials.gov