Intravenous Regional Analgesia of Dexmedetomidine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Normal Saline, Dexmedetomidine.
- Who it may be relevant to
- Registry conditions: Dexmedetomidine Analgesia, Knee Surgery. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Regional Intravenous Analgesic Effect of Dexmedetomidine in Knee Surgeries Under Spinal Anesthesia: A Prospective, Randomized, Double-Blind Controlled Study
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
Detailed 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
Interventions
- Drug Normal Saline
equal volume of normal saline - Drug Dexmedetomidine
0.5 mcg/kg of dexmedetomidine
Primary outcome measures
- postoperative duration of analgesia [Time frame: within 24 hours after the surgery]
Secondary outcome measures (6)
- total postoperative analgesic consumption [Time frame: in the first 24-hour postoperative]
- Sedation levels [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 [Time frame: Postoperatively every 15 min till full regression of the sensory block (score =0)]
- The motor block regression time in both lower limbs [Time frame: every 15 min till confirmation of full regression of the motor block (Modified Bromage Scale=0)]
- heart rate (HR), [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]
- systolic blood pressure (SBP) [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]
Eligibility criteria
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"
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Faculty of Medicine-Mansoura University — Al Mansurah
Identifiers
NCT: NCT07131579 · Dexmedetomidine IV analgesia