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NCT Number: NCT03834129

Dexmedetomidine Intra Venous Arthroplasty

Intravenous dexmedetomidine is a drug used in reanimation with sedative, anxiolytic and sympatholytic properties. Recent studies showed useful properties for anaesthesia : decrease of morphine consumption after a various type of surgery, sedative effect on patients under regional anaesthesia, prolongation of central or peripheral regional block. Dose-ranging study for intravenous dexmedetomidine showed that 2 µg/kg is an effective dose to prolong interscalene block. This study aims to determine if intravenous dexmedetomidine at 2 µg/kg allows a longer analgesic duration after a quadri-block (femoral, subgluteal sciatic, obturator and alateral cutaneous nerve blocks) with ropivacaine 0.32% for total knee replacement under regional anaesthesia.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinique Médipôle Garonne

Toulouse, Haute-Garonne, 31036, France

About this study

This is a prospective, randomized, double-blind controlled trial with two parallel groups. All patients undergoing total knee arthroplasty under regional anaesthesia and sedation will be screened for inclusion in the protocol. In the pre-anaesthesia room, after the implementation of classical monitoring with an oxygen mask and a peripheral venous catheter, all patients will receive an antibioprophylaxy according to SFAR recommendations and injection of 10 mg of IV dexamethasone.

The patients will be then randomized in 2 groups:

  • Dexmedetomidine group (Dex group) : Two administrations of 1 microg/kg of Dexdor® in 250 ml of sodium chloride during 30 min. The first injection will be performed in the pre-anaesthesia unit and the second in the operating room with a free interval of 60 min between the beginning of the 2 injections.
  • Control group : Two administrations of 250 ml of sodium chloride during 30 min according to the same former recommendations.

Under ultrasonography guidance and with in-plan technic, a quadri-block (femoral, sciatic subgluteal, obturator and lateral cutaneous nerve blocks) with a maximum of 225 mg of ropivacaine diluted in 70 ml of sodium chloride (ropivacaine 0.32 %) will be performed. If needed, sedation with 5 µg of sufentanil and 1 to 2 mg of midazolam will be performed before regional anaesthesia.

In the operating room, under close monitoring, the patients will receive a bolus of Ketamine 0.3 mg/kg and a propofol bolus of 0.3 mg/kg followed by a continuous infusion if needed. The total dose of propofol used for sedation, conversion to general anaesthesia or any complications concerning anaesthesia or dexmedetomidine (hypotension, bradycardia, arrhythmia, advance cardiac block) will be collected. Postoperative analgesia will be reached with IV 1 g paracetamol and 100 mg ketoprofen starting during surgery and following in the surgical ward by oral paracetamol 1 g / 6 h and oral ibuprofen 400 mg / 8 h. In post anaesthesia care unit all the patients will have oxycodone titration if pain VRS (verbal rating scale) >3 and oxycodone 10 mg/ 4 h in the surgical ward if pain VRS (verbal rating scale) >3.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years and older
  • Patients undergoing elective total knee arthroplasty
  • Consent for participation
  • Affiliation to the french social security system
  • For women of child bearing potential without contraception, beta-HCG negative result

Exclusion criteria

  • Chronic pain syndrome requiring preoperative morphine use (class 3)
  • Hypersensitivity to dexmedetomidine
  • Allergy to nonsteroidal anti-inflammatory drugs
  • Contraindication for locoregional anesthesia
  • Patient wishing a general anesthesia
  • Weight>100 kg, obstructive sleep apnea syndrome or gastrooesophageal reflux complicating the sedation with spontaneous ventilation
  • Known acute ischemic disease
  • Severe liver failure
  • Uncontrolled low blood pressure
  • Heart rate < 60 bpm
  • Advanced cardiac block (Level 2 or 3) except if pacemaker
  • Pregnant or breastfeeding women
  • Communication difficulties or neuropsychiatric disorder
  • Patients under protection of the adults (guardianship, curators or safeguard of justice)

Treatment and study plan

Dexmedetomidine

Drug

Two administrations, before anesthesia and during surgery, by intravenous infusion of dexmedetomidine 1 μg/kg in 250 ml of physiological serum for 30 minutes

Sodium chloride 0.9%

Drug

Two administrations, before anesthesia and during surgery, by intravenous infusion of 250 ml of physiological serum for 30 minutes

Primary outcomes

  1. Evaluate the effect of dexmedetomidine infusion 2 μg/kg in pre-anesthesia and operative room, on duration of postoperative analgesia after a knee arthroplasty performed under locoregional anesthesia.

    Time frame: 48 hours

    Duration of analgesia defined as the time between the performance of regional anesthesia and the first dose of rescue analgesia with opioides.

Secondary outcomes

  1. Incidence of hypotension or bradycardia Events.

    Time frame: 48 hours

    Number of complications due to dexmedetomidine (hypotension or bradycardia episodes)

  2. Maximal postoperative pain.

    Time frame: 48 hours

    Pain VRS verbal rating scale ranging from 0 to 10 (0=no pain, 10=worst possible pain)

  3. Postoperative opioids morphine consumption.

    Time frame: 48 hours

    Postoperative cumulated dose of oxynorm (mg)

  4. Dose of hypnotic drug during surgery.

    Time frame: 4 hours

    Total amount of propofol (mg) administered during surgery

  5. Ability to walk

    Time frame: Days 0, 1 and 2

    Distance < 50 m or > 50 m

  6. Quadricep mobilization

    Time frame: Days 0, 1 and 2

    0 : paralysis ; 1 : paresis ; 2 : normal contraction

  7. Foot elevator muscle mobilization

    Time frame: Days 0, 1 and 2

    0 : paralysis ; 1 : paresis ; 2 : normal contraction

Sponsors and collaborators

Lead sponsor

CMC Ambroise Paré

Other

Registry information

Official study title

Interest of Intravenous Dexmedetomidine (Dexdor®) in the Knee Replacement Surgery Performed Under Locoregional Anesthesia: a Randomized, Double Blind, Controlled Clinical Trial

Acronym: DIVA

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 7, 2019
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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