Hemodynamic Responses of Dexmedetomidine, Lidocaine or Propofol Infusions During Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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This study will be carried out to compare the efficacy of dexmedetomidine, propofol or lidocaine infusions in attenuation of hemodynamic responses to pneumoperitoneum during adult laparoscopic cholecystectomy using electrical cardiometry.

Detailed Description
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Many drug infusions have been used to control hemodynamic responses to laparoscopic surgeries like propofol, fentanyl, esmolol with varying degrees of success. Dexmedetomidine has sedative and analgesic properties seems to be appropriate enough to control the sympathetic response as well as provide a stable hemodynamics

Official Title
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Comparative Study Between the Hemodynamic Responses of Dexmedetomidine, Lidocaine or Propofol Infusions During Laparoscopic Cholecystectomy

Conditions
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Hemodynamic Responses, Laparoscopic Cholecystectomy, Dexmedetomidine, Lidocaine, Propofol

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Propofol
* Drug: Lidocain
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists I patients. Patients between the ages of ≥ 20 and ≤ 60 years of both sexes. Exclusion Criteria: Hypersensitivity to dexmedetomidine, propofol or lidocaine. 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>Patients will receive infusion of 25 ml normal saline in 50 ml syringe pump. | Drug: normal saline<br>* Patients will receive infusion of 25 ml normal saline in 50ml syringe pump (control group).<br>|
| Active Comparator: Dexmedetomidine group<br>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. | Drug: Dexmedetomidine<br>* 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.<br>|
| Active Comparator: Propofol<br>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 | Drug: Propofol<br>* 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.<br>|
| Active Comparator: Lidocaine<br>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. | Drug: Lidocain<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Noninvasive mean blood pressure | mean blood pressure will be noted by a standard automated multi channel monitor will be connected to each patient | Intraoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative rescue drugs | Patients that will need rescue drugs (fentanyl) will be recorded with the total dose used. | Intraoperatively | 
| Post extubation sedation | Post extubation sedation assessment will be done in each group using Ramsey's sedation score. Anxious, agitated or restless = (1) Cooperative, oriented and tranquil = (2) Responsive to command only = (3) Brisk response to light glabellar tap or loud auditory stimulus = (4) Sluggish response to light glabellar tap or loud auditory stimulus = (5) No response = (6) | 24 hour postoperatively |