Dexmedetomidine Intra Venous Arthroplasty

Primary Total Knee Arthroplasty Clinical Trial

— DIVA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03834129
• Other study ID #: 2018/08
• Status: Completed
• Phase: Phase 3
• Start date: May 13, 2019
• Est. completion date: January 11, 2020

Study information

• Verified date: February 2020
• Source: CMC Ambroise Paré
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: January 11, 2020
• Est. primary completion date: January 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Primary Total Knee Arthroplasty

Intervention

Drug:
• Dexmedetomidine
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%
Two administrations, before anesthesia and during surgery, by intravenous infusion of 250 ml of physiological serum for 30 minutes

Locations

Country	Name	City	State
France	Clinique Médipôle Garonne	Toulouse	Haute-Garonne

Sponsors (1)

Lead Sponsor	Collaborator
CMC Ambroise Paré

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	48 hours
Secondary	Incidence of hypotension or bradycardia Events.	Number of complications due to dexmedetomidine (hypotension or bradycardia episodes)	48 hours
Secondary	Maximal postoperative pain.	Pain VRS verbal rating scale ranging from 0 to 10 (0=no pain, 10=worst possible pain)	48 hours
Secondary	Postoperative opioids morphine consumption.	Postoperative cumulated dose of oxynorm (mg)	48 hours
Secondary	Dose of hypnotic drug during surgery.	Total amount of propofol (mg) administered during surgery	4 hours
Secondary	Ability to walk	Distance < 50 m or > 50 m	Days 0, 1 and 2
Secondary	Quadricep mobilization	0 : paralysis ; 1 : paresis ; 2 : normal contraction	Days 0, 1 and 2
Secondary	Foot elevator muscle mobilization	0 : paralysis ; 1 : paresis ; 2 : normal contraction	Days 0, 1 and 2