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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NOT_YET_RECRUITING
PHASE2/PHASE3
90 participants
INTERVENTIONAL
2025-10-31
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group L
IV Lidocaine infusion:
IV Lidocaine infusion
2 mg/kg/h (the total dose of lidocaine per hour will be calculated and add to normal saline 0.9% to total volume 50 ml and infused by a rate 50 ml/h till the end of the procedure
Group C
IV normal saline
IV normal saline
IV normal saline 0.9% , rate 50 ml/h
Interventions
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IV Lidocaine infusion
2 mg/kg/h (the total dose of lidocaine per hour will be calculated and add to normal saline 0.9% to total volume 50 ml and infused by a rate 50 ml/h till the end of the procedure
IV normal saline
IV normal saline 0.9% , rate 50 ml/h
Eligibility Criteria
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Inclusion Criteria
2. Elective laparoscopic cholecystectomy for symptomatic cholelithiasis or chronic cholecystitis
3. ASA physical status I-II
4. BMI \< 35 kg/m2
5. Preoperative CRP \<20 mg/L
6. Informed consent provided
Exclusion Criteria
2. Conversion to open surgery
3. Pre-op CRP \>20 mg/L
4. Allergy to lidocaine or local anesthetics
5. Known hepatic or renal dysfunction
6. Chronic inflammatory conditions
7. Current immunosuppressive therapy
8. Cardiac arrhythmias or heart block without pacemaker
9. ASA physical status III, IV or above
10. Pregnancy or breastfeeding
11. Psychiatric disorders
18 Years
60 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Noha Yahia Mohammd El-hagagy
Lecturer of anesthesia and intensive care, faculty of medicine, Assiut university.
Principal Investigators
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Noha Y Mohamed, MD
Role: PRINCIPAL_INVESTIGATOR
Lecturer in anesthesia and intensive care department, faculty of medicine,
Noha Y Mohammed, MD
Role: PRINCIPAL_INVESTIGATOR
Lecturer in anesthesia and intensive care department, faculty of medicine,
Locations
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Assiut university main hospital
Asyut, Assiut Governorate, Egypt,, Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Afaf Radi
Identifier Type: -
Identifier Source: org_study_id
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