Walking the Isobole of Drug Interaction
Walibi
1 other identifier
interventional
87
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 3, 2014
CompletedFirst Posted
Study publicly available on registry
February 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedDecember 4, 2015
December 1, 2015
1.6 years
February 3, 2014
December 3, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Blood pressure
Continuously stored on a laptop (systolic, diastolic and mean blood pressure over time) using a Philips Non Invasive Blood Pressure measurements every minute and a Nexfin monitor (continuous non invasive blood pressure measurement)
From start drug till intubation which will take on average 15 minutes of measurement
Secondary Outcomes (5)
Electro Encephalographic derived indices of anesthetic depth
From start first drug till intubation, which will take on average 15 minutes of measurement
Cerebral and tissue oxygenation
From start drug till intubation, which will take on average 15 minutes of measurement
Heart rate
From start first drug till intubation, which will take on average 15 minutes of measurement
Probability of tolerance to laryngoscopy
one minute before laryngoscopy till three minutes after
Cardiac index
From start first drug till intubation, which will take on average 15 minutes of measurement
Study Arms (4)
Group A propofol + remifentanil
ACTIVE COMPARATORPropofol highest dose, remifentanil lowest dose, TOL 90% according to Bouillon model
Group B propofol + remifentanil
ACTIVE COMPARATORPropofol intermediate high, remifentanil intermediate low, TOL90% according to the Bouillon Model
Group C propofol + remifentanil
ACTIVE COMPARATORpropofol intermediate low+ remifentanil intermediate high: TOL 90% according to the Bouillon interaction model
group D propofol + remifentanil
ACTIVE COMPARATORpropofol lowest dose+ remifentanil highest dose: TOL 90% according to the Bouillon model
Interventions
Predicted TOL90% according to Bouillon model
TOL 90% according to the Bouillon interaction model
TOL 90% according to the Bouillon interaction model
TOL 90% according to the Bouillon interaction model
Eligibility Criteria
You may qualify if:
- Written informed consent
- General anesthesia required for the procedure
- Age: 18 years and older
- American Society of Anesthesiologists (ASA) physical status I to III
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Medical Center Groningen
Groningen, Provincie Groningen, 9713EZ, Netherlands
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hugo EM Vereecke, MD, PhD
University Hospital Medical center, university of groningen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
February 3, 2014
First Posted
February 20, 2014
Study Start
February 1, 2014
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
December 4, 2015
Record last verified: 2015-12