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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | Patients will receive infusion of 25 ml normal saline in 50 ml syringe pump. |
|
| Dexmedetomidine group | Active Comparator | 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 | Active Comparator | 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 |
|
| Lidocaine | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed M Nassar, MSc | Contact | +20 122 682 5175 | ahmednasar35@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Menoufia University | Recruiting | Shibīn al Kawm | Menoufia | Egypt |
The data will be available upon reasonable request from the corresponding author from one year after study completion
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from one year after study completion
The data will be available upon reasonable request from the corresponding author
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| Propofol | Drug | 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 | Drug | 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 | Drug | Patients will receive infusion of 25 ml normal saline in 50ml syringe pump (control group). |
|
| 24 hour postoperatively |
| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D015742 | Propofol |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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