Dexmedetomidine Intra Venous Arthroplasty

NCT03834129 | Completed Phase 3

• 1 other identifier: 2018/08
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Total Knee Arthroplasty

Outcome Measures

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.

  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 Outcomes (7)

• Incidence of hypotension or bradycardia Events.

  48 hours

• Maximal postoperative pain.

  48 hours

• Postoperative opioids morphine consumption.

  48 hours

• Dose of hypnotic drug during surgery.

  4 hours

• Ability to walk

  Days 0, 1 and 2

Study Arms (2)

(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%

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%

Drug: sodium chloride 0.9%

Interventions

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

(Dex group) intravenous infusion of dexmedetomidine

sodium chloride 0.9% DRUG

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

(Control group) intravenous infusion of physiological serum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• CMC Ambroise Paré: lead

Study Sites (1)

Clinique Médipôle Garonne

Toulouse, Haute-Garonne, 31036, France

Location

Related Publications (1)

• 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.

  PMID: 33087480 RESULT

MeSH Terms

Interventions

Dexmedetomidine; Sodium Chloride

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: February 7, 2019
• Study Start: May 13, 2019
• Primary Completion: January 11, 2020
• Study Completion: January 11, 2020
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)