Bioavailability of Intranasal Dexmedetomidine

Anesthesia Clinical Trial

— INDEX  

Official title:

Intranasal Dexmedetomidine Pharmacokinetics on Patients Under General Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05065775
• Other study ID #: INDEX
• Status: Completed
• Phase: Phase 4
• Start date: November 1, 2021
• Est. completion date: May 10, 2022

Study information

• Verified date: May 2022
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim of this study is to characterize the pharmacokinetics of dexmedetomidine in supine, anesthetized adult patients after intranasal dosing.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 10, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Arthritis
• Arthritis Knee
• Arthritis of Hip
• Pharmacokinetics

Intervention

Device:
• Dexmedetomidine
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™)

Locations

Country	Name	City	State
Finland	Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital and University of Turku	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative bioavailability (%) of intranasally given dexmedetomidine		4 hours