Intravenous Regional Analgesia of Dexmedetomidine

N/AEnrolling By InvitationNCT07131579

Mansoura University100 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

100

Conditions

Dexmedetomidine Analgesia Knee Surgery

Interventions

Normal SalineDRUG

equal volume of normal saline

DexmedetomidineDRUG

0.5 mcg/kg of dexmedetomidine

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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"

Locations (1)

Faculty of Medicine-Mansoura University

Al Mansurah, Egypt

Outcomes

Primary Outcomes

postoperative duration of analgesia

the time measured from the study drug injection to the first request of analgesia by the patient

Time frame: within 24 hours after the surgery

Secondary Outcomes

total postoperative analgesic consumption

Time frame: in the first 24-hour postoperative

Sedation levels

Ramsay Sedation Score (RSS) (the score from 1-6; where 1 = anxious, agitated, 2 =cooperatives, oriented, 3 =respond to command only, 4 =brisk response to stimulus, 5 =sluggish response to stimulus, 6 =no response to stimulus)

Time frame: done Perioperatively at the following time points (Immediately before spinal anesthesia and immediately before tourniquet deflation. Then 5, 15, 30 min besides, 1, 2, 4, and 6 hours after tourniquet deflation)

The time of sensory block regression in both lower limbs

using three-point scale via pinprick test over the limb in both limbs separately (where; 0 = Normal sensation (absent sensory block), 1 = Dull sensation (partial sensory block) and 2 = No sensation (complete sensory block)

Time frame: Postoperatively every 15 min till full regression of the sensory block (score =0)

The motor block regression time in both lower limbs

using Modified Bromage Scale (0-3)

Time frame: every 15 min till confirmation of full regression of the motor block (Modified Bromage Scale=0)

heart rate (HR),

beat per minute

Time frame: preoperative, immediately after inject both spinal anesthesia and study drug, then every 5 minutes for the first 30 minutes and then every 15 minutes till end of the surgery. also, record after tourniquet deflation 5, 15, 30 min beside 1, 2, 4, 6 hours

Data from ClinicalTrials.gov

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