Dexmedetomidine, Hemodynamic Responses, Laparoscopic Cholecystectomy, Lidocaine, Propofol
Conditions
Brief summary
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
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
Interventions
DRUGDexmedetomidine
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.
DRUGPropofol
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.
DRUGLidocain
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.
DRUGnormal saline
Patients will receive infusion of 25 ml normal saline in 50ml syringe pump (control group).
Sponsors
Menoufia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Noninvasive mean blood pressure | Intraoperatively | mean blood pressure will be noted by a standard automated multi channel monitor will be connected to each patient |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative rescue drugs | Intraoperatively | Patients that will need rescue drugs (fentanyl) will be recorded with the total dose used. |
| Post extubation sedation | 24 hour postoperatively | 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) |
Countries
Egypt
Contacts
Primary ContactAhmed M Nassar, MSc
Outcome results
None listed