Dexmedetomidine AnalgesiaDexmedetomidinNCT07131579
Intravenous Regional Analgesia of Dexmedetomidine
A study testing Normal Saline and Dexmedetomidine in people with Dexmedetomidine Analgesia and Knee Surgery, run by Mansoura University at 1 site in Egypt.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Dexmedetomidine Analgesia, Knee Surgery
- What is being tested?
- Normal Saline and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jan 2026to 30 Aug 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Regional Intravenous Analgesic Effect of Dexmedetomidine in Knee Surgeries Under Spinal Anesthesia: A Prospective, Randomized, Double-Blind Controlled Study
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
Read the 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
- Conditions
- Dexmedetomidine Analgesia, Knee Surgery
- Being tested
- Normal Saline, Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal SalineDrug
equal volume of normal saline
DexmedetomidineDrug
0.5 mcg/kg of dexmedetomidine
| Study group | Role | What they receive |
|---|---|---|
| control | Placebo comparator | after spinal anesthesia; patient will receive normal saline injected intravenously below the Pneumatic tourniquet after its inflation Receives: Drug: Normal Saline |
| Dexmedetomidine | Active comparator | 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 Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative duration of analgesia
the time measured from the study drug injection to the first request of analgesia by the patient
Measured: within 24 hours after the surgery
Secondary outcomes (6)
total postoperative analgesic consumption
mg
Measured: 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)
Measured: 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)
Measured: 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)
Measured: every 15 min till confirmation of full regression of the motor block (Modified Bromage Scale=0)
heart rate (HR),
beat per minute
Measured: 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)
mmHg
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start12 Jan 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dexmedetomidine AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, maha abou-zeid, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131579
- Sponsor's protocol ID
- Dexmedetomidine IV analgesia
- Acronym
- Dexmedetomidin
- Status last verified
- Sep 2026
- First submitted
- 6 Aug 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No