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Enrolling by Invitation

NCT Number: NCT07131579

Intravenous Regional Analgesia of Dexmedetomidine

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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Key information

Conditions

Dexmedetomidine Analgesia Knee Surgery

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine-Mansoura University

Al Mansurah, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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"

Treatment and study plan

normal saline

Drug

equal volume of normal saline

Dexmedetomidine

Drug

0.5 mcg/kg of dexmedetomidine

Primary outcomes

  1. postoperative duration of analgesia

    Time frame: within 24 hours after the surgery

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

Secondary outcomes

  1. total postoperative analgesic consumption

    Time frame: in the first 24-hour postoperative

    mg

  2. 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)

    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)

  3. 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)

    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)

  4. 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)

    using Modified Bromage Scale (0-3)

  5. 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

    beat per minute

  6. 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

    mmHg

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Regional Intravenous Analgesic Effect of Dexmedetomidine in Knee Surgeries Under Spinal Anesthesia: A Prospective, Randomized, Double-Blind Controlled Study

Acronym: Dexmedetomidin

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 20, 2025
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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