Bioavailability of Intranasal Dexmedetomidine (INDEX)
Intranasal Dexmedetomidine Pharmacokinetics on Patients Under General Anesthesia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
To date, intranasal dexmedetomidine pharmacokinetics have not been studied before on anesthetized adult patients in supine position. As use of intranasal dexmedetomidine is growing, it is crucial to enhance knowledge of its pharmacokinetics.
Open, exploratory study design will be used. Study population will consist of patients coming to elective unilateral hip or knee arthroplasty under general anesthesia in Turku University Hospital, Salo unit. Thirty patients compatible with the inclusion and exclusion criteria will be entered into the study after receiving informed consent. Plasma concentrations of dexmedetomidine and other significant data will be collected prospectively.
Intranasal dexmedetomidine 100 ug will be administered shortly after induction of general anesthesia using a mucosal atomization (LMA MAD Nasal™) device, according to normal local protocol. Second cannula will be placed after patient is anesthetized, in order to obtain blood samples. Venous blood samples will be obtained immediately prior to administration of dexmedetomidine (baseline) and thereafter at 5, 15, 45 min and 1, 4 h into EDTA tubes for determination of dexmedetomidine, and possibly adrenaline and noradrenaline plasma concentrations.
Vital signs (heart rate, blood pressure and peripheral oxygen saturation) will be followed during the operation, as well as in the post anesthesia care unit according to the local protocol. Before patients will be admitted to the ward, they are expected to be appropriately arousable and have vital signs in normal limits.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Turku, Finland
- Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital and University of Turku
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The patient is scheduled for elective unilateral total knee arthroplasty or hip arthroplasty under general anesthesia
- Fluent skills in finnish language (to understand the given information and to be able to give informed consent and communicate with the study personnel)
- Age between 35 and 80 years
- Weight between 50 and 100 kg
- ASA (American Society of Anesthesiologists) status 1-3
- Written informed consent from the patient
Exclusion Criteria:
- A previous history of intolerance to the study drug or related compounds and additives
- Disease or condition affecting patient's ability to give written informed consent
- Existing or recent significant disease possible affecting absorption, distribution, metabolism, excretion or response to the study drug
- History of cardiac disease (valvular insufficiency, severe left ventricular dysfunction) or abnormal ECG rhythm (bradycardia < 50/min, 2nd or 3rd degree atrio-ventricular block, pacemaker)
- Chronic opioid use or use of other analgesic adjuvants such as pregabalin, gabapentin, amitriptyline or duloxetine
- Participation in any other study concomitantly or within one month prior to the entry into this study
- Clinically significant abnormal findings in physical examination or laboratory screening
- Use of drugs or natural products known to cause enzyme induction or inhibition
- Pregnancy or breastfeeding
- Spinal anesthesia
- Preoperative systolic blood pressure <110 mmHg
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Dexmedetomidine
Single intranasal 100 µg bolus dose of dexmedetomidine
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Single intranasal dexmedetomidine dose of 100 µg.
Intranasal dexmedetomidine will be administered shortly after induction of anesthesia using a mucosal atomization devise (LMA MAD Nasal™)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Relative bioavailability (%) of intranasally given dexmedetomidine
Time Frame: 4 hours
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4 hours
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Panu Uusalo, MD, PhD, University of Turku and Turku University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Joint Diseases
- Musculoskeletal Diseases
- Arthritis
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Dexmedetomidine
Other Study ID Numbers
- INDEX
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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