Intravenous Regional Analgesia of Dexmedetomidine

Mansoura University

Status: Invitation-only

Conditions: Knee Surgery; Dexmedetomidine Analgesia

Treatments: Drug: Normal Saline; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT07131579

Dexmedetomidine IV analgesia

Details and patient eligibility

About

Dexmedetomidine is a highly selective α₂-adrenergic receptor agonist that exerts its effects by inhibiting the release of norepinephrine at presynaptic nerve terminals, leading to reduced sympathetic activity; This mechanism results in analgesia, sedation, and anxiolysis without significant respiratory depression

Full description

In the context of intravenous regional anesthesia (IVRA), dexmedetomidine has been employed as an adjuvant to local anesthetics like lidocaine to improve block characteristics; Clinical studies have demonstrated that adding dexmedetomidine to lidocaine in IVRA accelerates the onset of sensory and motor blocks, extends the duration of postoperative analgesia, and reduces the incidence of tourniquet pain

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-60 years
• American Society of Anesthesiologists (ASA) Physical Status Classification System I or II
• Scheduled for elective knee surgery under spinal anesthesia
• Body mass index (BMI) 18-30 kg/m²
• Able to provide informed consent

Exclusion criteria

• Pregnant or lactating women
• Hypersensitivity to dexmedetomidine
• Chronic kidney diseases serum creatinine >1.5 mg\dl or Patient has known renal disease
• Chronic opioid or sedative use
• Any cardiac conduction abnormalities
• Uncontrolled arterial hypertension
• Neuropathy
• Diabetes mellitus
• Impaired perfusion of the operative limb (Edema, Peripheral vascular Disease e.g "Raynaud Phenomenon")
• History or recent lower limb deep venous thrombosis (DVT) or Phlebitis
• Infection or vascular access limitation in the operated lower limbs
• Any contraindication of spinal anesthesia e.g "Coagulopathy"
• Any contraindications for tourniquet e.g "sickle cell anemia"

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

control

Placebo Comparator group

Description:

after spinal anesthesia; patient will receive normal saline injected intravenously below the Pneumatic tourniquet after its inflation

Treatment:

Drug: Normal Saline

Dexmedetomidine

Active Comparator group

Description:

after spinal anesthesia; patient will receive 0.5 mcg/kg dexmedetomidine, diluted in a normal saline injected intravenously below the Pneumatic tourniquet after its inflation

Treatment:

Drug: Dexmedetomidine