Premedication with Intranasal Dexmedetomidine in Sedation of Patients Undergoing Total Knee Arthroplasty

NCT04859283 | Completed Phase 4

• 1 other identifier: TKADEX
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to find out if preoperatively given dexmedetomidine is effective analgesic adjuvant for treating postoperative pain in patients undergoing elective total knee arthroplasty (TKA). Another aim is to determine if premedication with intranasal dexmedetomidine could provide sufficient sedation to alleviate anxiety during TKA.

Conditions

Knee Osteoarthritis; Pain, Postoperative

Keywords

intranasal; dexmedetomidine; multimodal analgesia

Outcome Measures

Primary Outcomes (3)

• Change in numerical rating scale (NRS 0-100 mm, min 0, max 100, higher score means worse outcome)

  Number of patients with visual rating scale value under 30 mm

  24 hours

• Change in intraoperative sedatives (mg) administered

  Change from baseline midazolam and fentanyl consumption (mg)

  From anesthesia induction to the end of surgery.

• Change in opioid consumption (mg) postoperatively

  Change from baseline opioid consumption (mg) postoperatively at 24 hours

  24 hours

Secondary Outcomes (3)

• Change (mmHg) in hemodynamic parameter (blood pressure)

  24 hours

• Change (%) in respiratory parameter (peripheral oxygen saturation, SpO2)

  24 hours

• Number of patients with adverse events as a measure of safety and tolerability

  24 hours

Study Arms (2)

DEX-group

ACTIVE COMPARATOR

intranasal dexmedetomidine 1 µg/kg

Drug: Dexmedetomidine

PLACEBO-group

PLACEBO COMPARATOR

intranasal saline 10 µL/kg

Drug: Placebo

Interventions

Dexmedetomidine DRUG

Intranasal dexmedetomidine 1µg/kg will be administered 30min before the induction of anesthesia using a LMA MAD Nasal-device

Also known as: Dexdor

DEX-group

Placebo DRUG

Intranasal saline (10 µL/kg) will be administered 30 min before the induction of anesthesia using a LMA MAD NasalTM -device. The dose is euvolemic to 1 µg/mL dexmedetomidine.

Also known as: Saline

PLACEBO-group

Eligibility Criteria

• Age: 35 Years - 80 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 (TKA) under spinal 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
• 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 disease possible affecting absorption, distribution, metabolism, excretion or response to the study drug
• History of severe cardiac disease (valvular insufficiency, severe left ventricular dysfunction) or abnormal ECG rhythm (bradycardia \< 50/min, 2nd or 3rd degree atrioventricular-block, pacemaker)
• Preoperative systolic blood pressure \<110 mmHg
• Chronic use of strong opioids, 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
• Pregnancy or breastfeeding
• Use of any drugs known to cause enzyme induction or inhibition for a period of 30 days prior to the study, use of any natural products (including grapefruit products) for at least 14 days prior to the study and caffeine containing products for at least 24 hours prior to the study. The use of regular doses of paracetamol is allowed.

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

Related Publications (1)

• Tiainen SM, Heinonen H, Koskinen A, Makela S, Laitio R, Loyttyniemi E, Makela K, Saari TI, Uusalo P. Premedication with intranasal dexmedetomidine in patients undergoing total knee arthroplasty under spinal anaesthesia (TKADEX)-a prospective, double-blinded, randomised controlled trial. BJA Open. 2025 Mar 3;13:100382. doi: 10.1016/j.bjao.2025.100382. eCollection 2025 Mar.

  PMID: 40114985 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain, Postoperative

Interventions

Dexmedetomidine; Sodium Chloride

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Suvi-Maria Tiainen, MD

  Turku University Hospital, University of Turku

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Head Physician

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 26, 2021
• Study Start: June 10, 2022
• Primary Completion: September 15, 2023
• Study Completion: January 20, 2025
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)