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Intravenous Versus Perineural Dexmedetomidine as Adjuvant in Adductor Canal Block for Total Knee Arthroplasty (dexmed_ACB)

M

Mansoura University

Status

Completed

Conditions

Post Spinal Anesthesia Shivering

Treatments

Drug: adductor canal block dexmedetomidine
Drug: intravenous dexmedetomidine

Study type

Interventional

Funder types

Other

Identifiers

NCT04266145
dexmedetomidine

Details and patient eligibility

About

Shivering increases the cardiac and systemic energy expenditure, oxygen consumption and carbon dioxide production. Definitive prevention and treatment of shivering is necessary to decrease the related complications and increase post-anesthetic comfort.

Full description

Dexmedetomidine a highly selective α2 adrenergic agonist used effectively as a safe analgesic via different routes and mechanisms, including intravenous (i.v.), neuraxial and perineural routes. Dexmedetomidine has been used for prevent shivering but, the results of its efficacy is still controversy.

No studies to date have investigated the best administration route of dexmedetomidine to dominantly prevent the occurrence of shivering after spinal anesthesia or associated with the least grade.

This prospective, randomized, double blinded study was designed to investigate the best administrative route of dexmedetomidine firstly, as a preventive of neuraxial shivering and secondly as adjunctive analgesic.

The incidence of post-spinal anesthesia shivering was the primary outcome. Perioperative hemodynamics, postoperative pain scores during rest and at 45-degree flexion of the knee, the analgesic duration, the first postoperative day analgesic consumption, the sedation score and early ambulation ability were the secondary outcomes.

Enrollment

56 patients

Sex

All

Ages

19 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • adult patients
  • both genders
  • American Society of Anesthesiologists physical status I and II
  • scheduled for unilateral primary TKA under spinal anesthesia

Exclusion criteria

  • chronic opioid use
  • known allergy to the used drugs
  • any contraindications to regional anesthesia like; patient refusal, coagulopathy, neuropathy or infection at the injection site

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

56 participants in 2 patient groups

intravenous dexmedetomidine
Active Comparator group
Description:
20 mL 0.25% levobupivacaine plus 1 mL normal saline will be administrated for adductor-canal-blockade while for intravenous solution; 0.5µg.kg-1 dexmedetomidine diluted in 20 mL normal saline will be prepared
Treatment:
Drug: intravenous dexmedetomidine
adductor-canal-blockade dexmedetomidine
Active Comparator group
Description:
20 mL 0.25% levobupivacaine containing 1 mL of 0.5 mcg.kg-1 dexmedetomidine will be used for adductor-canal-blockade whereas, 20 mL 0.9% saline will be prepared for intravenous infusion
Treatment:
Drug: adductor canal block dexmedetomidine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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