Hemodynamic Responses of Dexmedetomidine, Lidocaine or Propofol Infusions During Laparoscopic Cholecystectomy
NCT ID: NCT05937282
Last Updated: 2023-07-11
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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UNKNOWN
PHASE4
80 participants
INTERVENTIONAL
2023-07-01
2023-10-30
Brief Summary
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Detailed Description
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Dexmedetomidine has sedative and analgesic properties seems to be appropriate enough to control the sympathetic response as well as provide a stable hemodynamics
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Control group
Patients will receive infusion of 25 ml normal saline in 50 ml syringe pump.
normal saline
Patients will receive infusion of 25 ml normal saline in 50ml syringe pump (control group).
Dexmedetomidine group
Patients will receive infusion of dexmedetomidine in the dose of 0.4 μg/kg/hr. One ml dexmedetomidine (100 μg/ml) will be diluted with 24 ml normal saline in 50 ml syringe pump to achieve dilution of 4 μg/ml.
Dexmedetomidine
Patients will receive infusion of dexmedetomidine in the dose of 0.4 μg/kg/hr. One ml dexmedetomidine (100 μg/ml) will be diluted with 24 ml normal saline in 50 ml syringe pump to achieve dilution of 4 μg/ml.
Propofol
Patients will receive propofol infusion in the dose of 3 mg/kg/hr. (12) 25 ml propofol 1% (10 mg /ml) in 50 ml syringe pump
Propofol
Patients will receive propofol infusion in the dose of 3 mg/kg/hr. 25 ml propofol 1% (10 mg /ml) in 50 ml syringe pump.
Lidocaine
Patients will receive lidocaine infusion in the dose of 2 mg /kg/hr. (15) 25 ml lidocaine 1% (10 mg/ml) in 50 ml syringe pump.
Lidocain
Patients will receive lidocaine infusion in the dose of 2 mg /kg/hr.25 ml lidocaine 1% (10 mg/ml) in 50 ml syringe pump.
Interventions
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Dexmedetomidine
Patients will receive infusion of dexmedetomidine in the dose of 0.4 μg/kg/hr. One ml dexmedetomidine (100 μg/ml) will be diluted with 24 ml normal saline in 50 ml syringe pump to achieve dilution of 4 μg/ml.
Propofol
Patients will receive propofol infusion in the dose of 3 mg/kg/hr. 25 ml propofol 1% (10 mg /ml) in 50 ml syringe pump.
Lidocain
Patients will receive lidocaine infusion in the dose of 2 mg /kg/hr.25 ml lidocaine 1% (10 mg/ml) in 50 ml syringe pump.
normal saline
Patients will receive infusion of 25 ml normal saline in 50ml syringe pump (control group).
Eligibility Criteria
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Inclusion Criteria
* Patients between the ages of ≥ 20 and ≤ 60 years of both sexes.
Exclusion Criteria
* Diabetic patients (Hemoglobin A1C ≥ 7).
* Hypertensive patients (Blood presssure ≥ 140/90 mmHg) or patients on medications that affect hemodynamics as clonidine, methyldopa, β blockers and calcium channel blockers.
* Impaired liver function (serum albumin ≤ 3.5 g/dl, International normalized ratio≥ 1.3, total bilirubin \>1mg/dl).
* Impaired renal function (serum creatinine \>1.2 mg/dl, blood urea \>20mg/dl).
* Morbidly obese patients with body mass index ≥ 40.
* Patients with acute cholecystitis or active infection.
* Patients taking medications that may impair cognition.
* History of seizures.
20 Years
60 Years
ALL
No
Sponsors
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Menoufia University
OTHER
Responsible Party
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Ahmed Mohammed Nasar
Specialist
Locations
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Menoufia University
Shibīn al Kawm, Menoufia, Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2/2020ANET27
Identifier Type: -
Identifier Source: org_study_id
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