Dexmedetomidine Versus Lidocaine Infusions as Adjuvants to General Anesthesia for Chronic Pain Management After Mastectomy
NCT ID: NCT06910644
Last Updated: 2025-04-08
Study Results
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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RECRUITING
NA
90 participants
INTERVENTIONAL
2025-04-05
2025-12-01
Brief Summary
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Detailed Description
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Lidocaine is the local anesthetic, which is used more often, and it is considered the prototype of amino-amide local anesthetics. Dexmedetomidine (DEX) is a highly selective agonist that acts by binding with presynaptic alpha 2-adrenergic receptor and then activating the negative feedback loop of the sympathetic nerve response, leading to inhibited norepinephrine release from the sympathetic terminals and decreased reflex activity of the sympathetic nervous.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Dexmedetomidine group
Patients will receive 1 μg/kg of intravenous dexmedetomidine over 10 min followed by an intravenous infusion of 0.5 μg/kg/h.
Dexmedetomidine
Patients will receive 1 μg/kg of intravenous dexmedetomidine over 10 min followed by an intravenous infusion of 0.5 μg/kg/h.
Lidocaine group
Patients will receive a bolus of intravenous lidocaine 1.5mg/kg over 10 min followed by a continuous infusion of lidocaine 1.5mg/kg/h.
Lidocaine
Patients will receive a bolus of intravenous lidocaine 1.5mg/kg over 10 min followed by a continuous infusion of lidocaine 1.5mg/kg/h.
Control group
Patients will receive intravenous isotonic saline 0.9% in the same volume and manner as the study drugs.
Isotonic saline
Patients will receive intravenous isotonic saline 0.9% in the same volume and manner as the study drugs.
Interventions
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Dexmedetomidine
Patients will receive 1 μg/kg of intravenous dexmedetomidine over 10 min followed by an intravenous infusion of 0.5 μg/kg/h.
Lidocaine
Patients will receive a bolus of intravenous lidocaine 1.5mg/kg over 10 min followed by a continuous infusion of lidocaine 1.5mg/kg/h.
Isotonic saline
Patients will receive intravenous isotonic saline 0.9% in the same volume and manner as the study drugs.
Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologists (ASA) physical status II.
* Scheduled for mastectomy with axillary dissection (either modified radical mastectomy with or without latissimus dorsi flap or conservative breast surgery) due to breast cancer.
Exclusion Criteria
* Known allergy to any of the study drugs.
* Those with hepatic or renal insufficiency.
* Patients who are running regularly on B blockers.
* α2 adrenergic agonists and sedatives.
* Psychoactive medications.
18 Years
75 Years
FEMALE
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Mohamed Elsaid Abdel Fattah
Lecturer of Anesthesia, Surgical ICU and Pain Management, Faculty of Medicine, National Cancer Institute, Cairo University, Egypt.
Locations
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Cairo University
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AP2411-501-087-193
Identifier Type: -
Identifier Source: org_study_id
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