Primary Total Knee ArthroplastyPhase 3DIVANCT03834129
Dexmedetomidine Intra Venous Arthroplasty
A Phase 3 study testing Dexmedetomidine and sodium chloride 0.9% in people with Primary Total Knee Arthroplasty, run by CMC Ambroise Paré at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Total Knee Arthroplasty
- What is being tested?
- Dexmedetomidine and sodium chloride 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteFrance
- Study dates
- 13 May 2019to 11 Jan 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest of Intravenous Dexmedetomidine (Dexdor®) in the Knee Replacement Surgery Performed Under Locoregional Anesthesia: a Randomized, Double Blind, Controlled Clinical Trial
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.
Read the detailed description
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.
- Conditions
- Primary Total Knee Arthroplasty
- Being tested
- Dexmedetomidine, sodium chloride 0.9%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
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
| Study group | Role | What they receive |
|---|---|---|
| (Dex group) intravenous infusion of dexmedetomidine | Experimental | Pre-anesthetic and per-operative intravenous infusions of dexmedetomidine 1µg/kg in 250ml of sodium chloride 0.9% Receives: Drug: Dexmedetomidine |
| (Control group) intravenous infusion of physiological serum | Placebo comparator | Pre-anesthetic and per-operative intravenous infusions of 250ml of sodium chloride 0.9% Receives: Drug: sodium chloride 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Duration of analgesia defined as the time between the performance of regional anesthesia and the first dose of rescue analgesia with opioides.
Measured: 48 hours
Secondary outcomes (7)
Incidence of hypotension or bradycardia Events.
Number of complications due to dexmedetomidine (hypotension or bradycardia episodes)
Measured: 48 hours
Maximal postoperative pain.
Pain VRS verbal rating scale ranging from 0 to 10 (0=no pain, 10=worst possible pain)
Measured: 48 hours
Postoperative opioids morphine consumption.
Postoperative cumulated dose of oxynorm (mg)
Measured: 48 hours
Dose of hypnotic drug during surgery.
Total amount of propofol (mg) administered during surgery
Measured: 4 hours
Ability to walk
Distance < 50 m or > 50 m
Measured: Days 0, 1 and 2
Quadricep mobilization
0 : paralysis ; 1 : paresis ; 2 : normal contraction
Measured: Days 0, 1 and 2
Foot elevator muscle mobilization
0 : paralysis ; 1 : paresis ; 2 : normal contraction
Measured: Days 0, 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start13 May 2019
- Primary completion11 Jan 2020
- Study completion11 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Total Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- CMC Ambroise Paré
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834129
- Sponsor's protocol ID
- 2018/08
- Acronym
- DIVA
- Status last verified
- Apr 2026
- First submitted
- 5 Feb 2019
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chassery C, Marty P, Rontes O, Chaubard M, Vuillaume C, Basset B, Merouani M, Marquis C, De Lussy A, Delbos MC, Casalprim J, Bataille B, Naudin C, Ferre F, Delbos A. Total knee arthroplasty under quadruple nerve block with ropivacaine 0.32%: effect of addition of intravenous dexmedetomidine to intravenous dexamethasone on analgesic duration. Reg Anesth Pain Med. 2021 Feb;46(2):104-110. doi: 10.1136/rapm-2020-101749. Epub 2020 Oct 21.
PubMed 33087480
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Intravenous Dexmedetomidine (Dexdor®) in the Knee Replacement Surgery Performed Under Locoregional Anesthesia: a Randomized, Double Blind, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03834129
- Acronym / sponsor ID
- DIVA / 2018/08
- Conditions
- Primary Total Knee Arthroplasty
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- CMC Ambroise ParéUniversity, hospital or other
- Study start
- 13 May 2019 (actual)
- Primary completion
- 11 Jan 2020 (actual)
- Study completion
- 11 Jan 2020 (actual)
- First posted
- 7 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (Dex group) intravenous infusion of dexmedetomidine | Experimental | Drug: DexmedetomidinePre-anesthetic and per-operative intravenous infusions of dexmedetomidine 1µg/kg in 250ml of sodium chloride 0.9% |
| (Control group) intravenous infusion of physiological serum | Placebo comparator | Drug: sodium chloride 0.9%Pre-anesthetic and per-operative intravenous infusions of 250ml of sodium chloride 0.9% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineTwo administrations, before anesthesia and during surgery, by intravenous infusion of dexmedetomidine 1 μg/kg in 250 ml of physiological serum for 30 minutes | Drug | (Dex group) intravenous infusion of dexmedetomidine |
| sodium chloride 0.9%Two administrations, before anesthesia and during surgery, by intravenous infusion of 250 ml of physiological serum for 30 minutes | Drug | (Control group) intravenous infusion of physiological serum |
Primary outcome
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.
7 secondary outcomes
Incidence of hypotension or bradycardia Events.
Time frame: 48 hours
Maximal postoperative pain.
Time frame: 48 hours
Postoperative opioids morphine consumption.
Time frame: 48 hours
Dose of hypnotic drug during surgery.
Time frame: 4 hours
Ability to walk
Time frame: Days 0, 1 and 2
Quadricep mobilization
Time frame: Days 0, 1 and 2
Foot elevator muscle mobilization
Time frame: Days 0, 1 and 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Results publication: PubMed 33087480Chassery C, Marty P, Rontes O, Chaubard M, Vuillaume C, Basset B, Merouani M, Marquis C, De Lussy A, Delbos MC, Casalprim J, Bataille B, Naudin C, Ferre F, Delbos A. Total knee arthroplasty under quadruple nerve block with ropivacaine 0.32%: effect of addition of intravenous dexmedetomidine to intravenous dexamethasone on analgesic duration. Reg Anesth Pain Med. 2021 Feb;46(2):104-110. doi: 10.1136/rapm-2020-101749. Epub 2020 Oct 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine and sodium chloride 0.9% in people with Primary Total Knee Arthroplasty, run by CMC Ambroise Paré at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03834129, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.