Intravenous Regional Analgesia of Dexmedetomidine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-12

Study Completion Date

2027-08-30

Brief Summary

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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

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Detailed Description

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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

Conditions

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Dexmedetomidine Analgesia Knee Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The patient will be allocated into one of two equal (1:1) groups according to the drug injected intravenously below the Pneumatic tourniquet after its inflation. Group D (Dexmedetomidine) will receive 0.5 mcg/kg of dexmedetomidine, diluted in normal saline while, group P (placebo) will receive same volume normal saline

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

An anesthetist, not involved in the study , was responsible for randomization list construction, in blocks, opening the sealed envelopes and so, the preparation of the study drug

Study Groups

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control

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

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

equal volume of normal saline

Dexmedetomidine

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

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

0.5 mcg/kg of dexmedetomidine

Interventions

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Normal Saline

equal volume of normal saline

Intervention Type DRUG

Dexmedetomidine

0.5 mcg/kg of dexmedetomidine

Intervention Type DRUG

Eligibility Criteria

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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"

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No