Intravenous Regional Analgesia of Dexmedetomidine

NCT07131579 | Enrolling By Invitation

• 1 other identifier: Dexmedetomidine IV analgesia
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Dexmedetomidine Analgesia; Knee Surgery

Outcome Measures

Primary Outcomes (1)

• postoperative duration of analgesia

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

  within 24 hours after the surgery

Secondary Outcomes (6)

• total postoperative analgesic consumption

  in the first 24-hour postoperative

• Sedation levels

  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

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

• The motor block regression time in both lower limbs

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

• heart rate (HR),

  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

Study Arms (2)

control

PLACEBO COMPARATOR

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

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

Drug: Dexmedetomidine

Interventions

Normal Saline DRUG

equal volume of normal saline

control

Dexmedetomidine DRUG

0.5 mcg/kg of dexmedetomidine

Dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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"

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Medicine-Mansoura University

Al Mansurah, Egypt

Location

MeSH Terms

Interventions

Saline Solution; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia and Surgical Intensive Care

Model Details: 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

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 20, 2025
• Study Start: January 12, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): August 30, 2027
• Last Updated: January 21, 2026

Record last verified: 2025-08

Locations

EG (1)