Bioavailability of Intranasal Dexmedetomidine

NCT05065775 | Completed Phase 4

• 1 other identifier: INDEX
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pharmacokinetics; Arthritis Knee; Arthritis of Hip; Anesthesia

Keywords

Intranasal; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• Relative bioavailability (%) of intranasally given dexmedetomidine

  4 hours

Study Arms (1)

Dexmedetomidine

EXPERIMENTAL

Single intranasal 100 µg bolus dose of dexmedetomidine

Device: Dexmedetomidine

Interventions

Dexmedetomidine DEVICE

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™)

Also known as: Dexdor

Dexmedetomidine

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Turku University Hospital: lead

Study Sites (1)

Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital and University of Turku

Turku, Finland

Location

Study Officials

• Panu Uusalo, MD, PhD

  University of Turku and Turku University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 4, 2021
• Study Start: November 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: May 10, 2022
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)