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Walking the Isobole of Drug Interaction

NCT ID: NCT02067936

Last Updated: 2015-12-04

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-09-30

Brief Summary

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The investigators study whether four equipotent combinations of propofol and remifentanil (as predicted by interaction models for "tolerance of laryngoscopy") result in identical haemodynamic conditions, independent of their relative different balance between the concentration of propofol and remifentanil.

Detailed Description

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In anesthesia, the synergistic interaction between hypnotics and opioids is applied daily to give adequate anesthesia and analgesia at significantly lower doses compared with the ones needed if only one drug was given to reach the same effect. A lot of research has been done to quantify these interactions with a focus on the desired effects (Tolerance of laryngoscopy, tolerance of shake and shout etc...), but the simultaneous interaction on the unwanted side effects is less well described. The response surface model of Bouillon et al. and other models predict combinations of propofol and remifentanil effect-site concentrations that lead to an equipotent desired effect. Due to the availability of the models, the anesthesiologists now could use the knowledge on interactions to target specific effects more accurately, using predefined equipotent combinations of drugs: for instance, a desirable 90% probability of tolerance of laryngoscopy (TOL90) in the population can be reached through either a high propofol/low remifentanil combination, but equally well through a low propofol-high remifentanil combination.

However, at this time it is not known whether some of the combinations of propofol and remifentanil have a favorable hemodynamic stability compared to other equipotent combinations. The researcher in this study want to determine whether equipotent combinations of remifentanil and propofol (all deliberately selected to evoke 90% probability of "tolerance to laryngoscopy"), result in different effects on the undesired side effects of anesthetics, such as hemodynamic instability (hypotension, changes in heart rate or cardiac output), decreases in cerebral or tissue oxygenation (both measured with near infrared spectroscopy).

Conditions

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Hemodynamic Instability Disorder of Oxygen Transport Interaction Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group A propofol + remifentanil

Propofol highest dose, remifentanil lowest dose, TOL 90% according to Bouillon model

Group Type ACTIVE_COMPARATOR

Group A propofol + remifentanil

Intervention Type DRUG

Predicted TOL90% according to Bouillon model

Group B propofol + remifentanil

Propofol intermediate high, remifentanil intermediate low, TOL90% according to the Bouillon Model

Group Type ACTIVE_COMPARATOR

Group B propofol + remifentanil

Intervention Type DRUG

TOL 90% according to the Bouillon interaction model

Group C propofol + remifentanil

propofol intermediate low+ remifentanil intermediate high: TOL 90% according to the Bouillon interaction model

Group Type ACTIVE_COMPARATOR

Group C propofol + remifentanil

Intervention Type DRUG

TOL 90% according to the Bouillon interaction model

group D propofol + remifentanil

propofol lowest dose+ remifentanil highest dose: TOL 90% according to the Bouillon model

Group Type ACTIVE_COMPARATOR

group D propofol + remifentanil

Intervention Type DRUG

TOL 90% according to the Bouillon interaction model

Interventions

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Group A propofol + remifentanil

Predicted TOL90% according to Bouillon model

Intervention Type DRUG

Group B propofol + remifentanil

TOL 90% according to the Bouillon interaction model

Intervention Type DRUG

Group C propofol + remifentanil

TOL 90% according to the Bouillon interaction model

Intervention Type DRUG

group D propofol + remifentanil

TOL 90% according to the Bouillon interaction model

Intervention Type DRUG

Other Intervention Names

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propofol highest dose + remifentanil lowest dose Propofol intermediate high+ remifentanil intermediate low propofol intermediate low+remifentanil intermediate high Propofol lowest dose+ remifentanil highest

Eligibility Criteria

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Inclusion Criteria

* Written informed consent
* General anesthesia required for the procedure
* Age: 18 years and older
* American Society of Anesthesiologists (ASA) physical status I to III

Exclusion Criteria

* Refusal to participate in this study
* Contra-indications for the use of propofol or remifentanil
* BMI \> 35 kg/m2
* Central nervous system disorders (i.e. cerebrovascular accident, dementia, seizures, psychiatric disorders)
* Relevant hepatic disease (Child B or higher)
* Regular use of medication that affects the central nervous system (i.e. benzodiazepines, antidepressants, antipsychotics, antiepileptic drugs)
* Use of alpha-agonists or beta-blockers
* Overt signs of alcohol abuse
* Use of preoperative benzodiazepines (on the day of the study)
* Beta blockers eye drips
* Overt signs of Drugs abuse
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Hugo E.M.Vereecke

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hugo EM Vereecke, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Medical center, university of groningen

Locations

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University Medical Center Groningen

Groningen, Provincie Groningen, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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WALIBI-001

Identifier Type: -

Identifier Source: org_study_id