Clinique Médipôle Garonne
Toulouse, Haute-Garonne, 31036, France
NCT Number: NCT03834129
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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Notify Me18 year and older
All sexes
Interventional
Phase 3
Toulouse, Haute-Garonne, 31036, France
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Two administrations, before anesthesia and during surgery, by intravenous infusion of dexmedetomidine 1 μg/kg in 250 ml of physiological serum for 30 minutes
Two administrations, before anesthesia and during surgery, by intravenous infusion of 250 ml of physiological serum for 30 minutes
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.
Time frame: 48 hours
Number of complications due to dexmedetomidine (hypotension or bradycardia episodes)
Time frame: 48 hours
Pain VRS verbal rating scale ranging from 0 to 10 (0=no pain, 10=worst possible pain)
Time frame: 48 hours
Postoperative cumulated dose of oxynorm (mg)
Time frame: 4 hours
Total amount of propofol (mg) administered during surgery
Time frame: Days 0, 1 and 2
Distance < 50 m or > 50 m
Time frame: Days 0, 1 and 2
0 : paralysis ; 1 : paresis ; 2 : normal contraction
Time frame: Days 0, 1 and 2
0 : paralysis ; 1 : paresis ; 2 : normal contraction
CMC Ambroise Paré
Other
Interest of Intravenous Dexmedetomidine (Dexdor®) in the Knee Replacement Surgery Performed Under Locoregional Anesthesia: a Randomized, Double Blind, Controlled Clinical Trial
Acronym: DIVA
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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