Pharmacodynamic Interaction of REMI and DMED

Anesthesia Clinical Trial

— PIRAD  

Official title:

Pharmacodynamic Interactions Between Remifentanil and Dexmedetomidine (PIRAD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03143972
• Other study ID #: PIRAD-001
• Status: Completed
• Phase: Phase 4
• Start date: June 28, 2017
• Est. completion date: February 23, 2018

Study information

• Verified date: April 2024
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective is to map the pharmacokinetic / pharmacodynamic interaction between dexmedetomidine and remifentanil by observing changes in anesthetic depth. These changes will be related to drug concentrations using pharmacokinetic/pharmacodynamic (PKPD) modeling.

Description:

This study is designed to investigate whether the use of a combination of dexmedetomidine and remifentanil is clinically useful to provide anesthesia during surgical and diagnostic procedures and whether it could be used for anesthetic induction. Furthermore the aim is to gain better insights in the required dosing regimens, the inter-individual variability in response towards the combination and the associated side effects. Better characterization of this drug-drug interaction will presumably lead to more precise dosing regimens, which in turn, will lead to a reduction in the occurrence of oversedation, side effects and recovery times.

The objective is to map the pharmacokinetic / pharmacodynamic interaction between dexmedetomidine and remifentanil by observing changes in anesthetic depth, measured by hypnotic and analgesic endpoints such as modified observer's assessment of alertness and sedation scale (MOAA/S), response to electrical stimuli, response to laryngoscopy and electroencephalogram (EEG) derived indices. These effects will be related to drug concentrations using pharmacokinetic/pharmacodynamic (PKPD) modeling.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 23, 2018
• Est. primary completion date: February 23, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) Physical Status 1

• No medical history of significance

• No chronic use of medication, drugs, tobacco or more than 20 gr alcohol daily (oral contraceptives excluded).

• Concerning the cognitive function: Volunteers are considered to have sufficient cognitive reserve if they are able to read and comprehend the patient information form, if they can adequately answer the anamnestic questions during the screening process and if they are allowed to provide legitimate written informed consent.

• No selection will be made regarding ethnic background

• No exclusion criterium is present

Exclusion Criteria:

• Known intolerance to dexmedetomidine or remifentanil

• Volunteer refusal

• Age < 18 years or >70 years

• Pregnancy, or currently nursing

• Hairstyle with dreadlocks (EEG-monitoring will not be possible)

• Body mass index (BMI) <18 or >30 kg/m2.

• Neurological disorder (epilepsy, the presence of a brain tumor, a history of brain surgery, hydrocephalic disorders, depression needing treatment with anti-depressive drugs, a history of brain trauma, a subarachnoidal bleeding, TIA or cerebral infarct, psychosis or dementia , schizophrenia, alcohol or drug abuse).

• Diseases involving the cardiovascular system (hypertension, coronary artery disease, prior acute myocardial infarction, any valvular and/or myocardial disease involving

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Dexmedetomidine
Single drug administration
• Remifentanil
Single drug administration

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Hannivoort LN, Eleveld DJ, Proost JH, Reyntjens KM, Absalom AR, Vereecke HE, Struys MM. Development of an Optimized Pharmacokinetic Model of Dexmedetomidine Using Target-controlled Infusion in Healthy Volunteers. Anesthesiology. 2015 Aug;123(2):357-67. doi: 10.1097/ALN.0000000000000740. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerance of Laryngoscopy (TOL)	Tolerance of a laryngoscopy (yes/no) will be tested at the end of each infusion step during both studydays, when MOAA/s is 0 / 1 and will be related to the drug concentration(s).	35 - 255 minutes
Secondary	Modified observer's assessment of alertness and sedation scale (MOAA/s)	An hypnotic endpoint measuring depth of anesthesia.	During anesthesia sessions day 1 and day 2
Secondary	Electrical stimulus	Measuring analgesia by observing response to a standardized electrical stimulus	During anesthesia sessions day 1 and day 2
Secondary	Electroencephalogram (EEG)	A multichannel electroencephalogram will be recorded	During anesthesia sessions day 1 and day 2