Walking the isobole of drug interaction

Walking the Isobole of drug Interaction: Comparison of hemodynamic effects, cerebral and tissue oxygenation for 4 equipotent combinations of propofol and remifentanil

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002883-20-NL

Enrollment

Registered

2013-07-09

Start date

2013-09-30

Completion date

Unknown

Last updated

2013-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

elective ophthalmic surgery under general anesthesia.

Interventions

Trade Name: remifenatnil Product Name: ultiva Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: remifentanil CAS Number: 132875-61-7 Other descriptive name: REMIFENTANIL HYDROC

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - General anesthesia required for the procedure - Age: 18 years and older - American Society of Anesthesiologists (ASA) physical status I to III Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effects of the different combinations of propofol and remifentanil on the isobole of TOL90 and to compare hemodynamics, cerebral and tissue oxygenation for each equipotent combination. To describe the combination of propofol and remifentanil on the TOL90 isobole with the least hemodynamic side effects. This study will help the anesthesiologist to increase the safety of induction and maintenance of anesthesia as we will be able to provide a priori information on those combinations with the least side effects. Currently, the post hoc (after the induction) monitoring of side effects is the only way to guarantee safet;Secondary Objective: To investigate the effects of the different combinations of propofol and remifentanil on the isobole of TOL90 and to compare hemodynamics, cerebral and tissue oxygenation for each equipotent combination. To describe the combination of propofol and remifentanil on the TOL90 isobole with the least hemodynamic side effects. This study will help the anesthesiologist to increase the safety of induction and maintenance of anesthesia as we will be able to provide a priori information on those combinations with the least side effects. Currently, the post hoc (after the induction) monitoring of side effects is the only way to guarantee safet;Primary end point(s): 1) During non-steady-state induction: The relationship between changing drug concentrations of remifentanil and propofol with the changing BIS, Neurowave index, heart rate, non-invasive arterial blood pressure, cardiac output, StO2 and SctO2. 2) During maintenance (after equilibration at steady state TOL90), absolute bispectral index, Neurowave index, heart rate, non-invasive arterial blood pressure, cardiac output, StO2 and SctO2, and changes from baseline for all ;Timepoint(s) of evaluation of this end point: during operation	—

Measure

Time frame

Main Objective: To investigate the effects of the different combinations of propofol and remifentanil on the isobole of TOL90 and to compare hemodynamics, cerebral and tissue oxygenation for each equipotent combination. To describe the combination of propofol and remifentanil on the TOL90 isobole with the least hemodynamic side effects. This study will help the anesthesiologist to increase the safety of induction and maintenance of anesthesia as we will be able to provide a priori information on those combinations with the least side effects. Currently, the post hoc (after the induction) monitoring of side effects is the only way to guarantee safet;Secondary Objective: To investigate the effects of the different combinations of propofol and remifentanil on the isobole of TOL90 and to compare hemodynamics, cerebral and tissue oxygenation for each equipotent combination. To describe the combination of propofol and remifentanil on the TOL90 isobole with the least hemodynamic side effects. This study will help the anesthesiologist to increase the safety of induction and maintenance of anesthesia as we will be able to provide a priori information on those combinations with the least side effects. Currently, the post hoc (after the induction) monitoring of side effects is the only way to guarantee safet;Primary end point(s): 1) During non-steady-state induction: The relationship between changing drug concentrations of remifentanil and propofol with the changing BIS, Neurowave index, heart rate, non-invasive arterial blood pressure, cardiac output, StO2 and SctO2. 2) During maintenance (after equilibration at steady state TOL90), absolute bispectral index, Neurowave index, heart rate, non-invasive arterial blood pressure, cardiac output, StO2 and SctO2, and changes from baseline for all ;Timepoint(s) of evaluation of this end point: during operation

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Secondary

Measure	Time frame
Secondary end point(s): Total dose of atropine and ephedrine required to maintain heart rate > 40/min and mean arterial blood pressure > 60 mmHg, respectively. Tolerance of laryngoscopy at steady state TOL90: observing the number of responders to laryngoscopy at TOL90. Response is defined as significant motor response (movement of extremities, opening of eyes, gag reflex or coughing) or hemodynamic response (= 20% difference between the median HR, blood pressure or cardiac output of one minute before laryngoscopy, compared to the median values one minute after laryngoscopy). The probability of memory formation of these events is extremely low (even in the responders) due to the TOL90 dosing level that is far above the 99% tolerance of shake and shout level. ;Timepoint(s) of evaluation of this end point: during operation	—

Measure

Time frame

Secondary end point(s): Total dose of atropine and ephedrine required to maintain heart rate > 40/min and mean arterial blood pressure > 60 mmHg, respectively. Tolerance of laryngoscopy at steady state TOL90: observing the number of responders to laryngoscopy at TOL90. Response is defined as significant motor response (movement of extremities, opening of eyes, gag reflex or coughing) or hemodynamic response (= 20% difference between the median HR, blood pressure or cardiac output of one minute before laryngoscopy, compared to the median values one minute after laryngoscopy). The probability of memory formation of these events is extremely low (even in the responders) due to the TOL90 dosing level that is far above the 99% tolerance of shake and shout level. ;Timepoint(s) of evaluation of this end point: during operation

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Countries

Netherlands

Contacts

Public Contactresearch coordinator

University Medical Center Groningen

r.spanjersberg@umcg.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026