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this study will be undertaken-to evaluate the effect of oral amantadine versus IV amantadine premedication on the hemodynamic response to laryngoscopy ,tracheal intubation and surgical incision and their effect on β-endorphins.
Direct laryngoscopy and passage of endotracheal tube through the larynx is a noxious stimulus, which can provoke untoward response in the cardiovascular, respiratory and other physiological systems .Amantadine is a non-competitive NMDA receptor antagonist, and compared to ketamine, it is well tolerated with fewer side effects (mainly dizziness, sedation, and dry mouth). Amantadine's formulation permits the oral route for drug delivery, as well as the IV route. The side-effects profile of amantadine via all routes seems not to be harmful in appropriate dosages.. Amantadine has been clinically used as an antiviral drug, for dementia, and in the treatment of Parkinson's disease and spasticity. It is a non-competitive NMDA receptor antagonist, and compared to ketamine, it is well tolerated with fewer side effects (mainly dizziness, sedation, and dry mouth). Amantadine's formulation permits the oral route for drug delivery, as well as the IV route. The side-effects profile of amantadine via all routes seems not to be harmful in appropriate dosages.
In the central nervous system, beta-endorphins bind mu-opioid receptors and exert their primary action at presynaptic nerve terminals. However, instead of inhibiting substance P, they exert their analgesic effect by inhibiting the release of GABA, an inhibitory neurotransmitter, resulting in excess production of dopamine.
this study will be undertaken-to evaluate the effect of oral amantadine versus IV amantadine premedication on the hemodynamic response to laryngoscopy ,tracheal intubation and surgical incision and their effect on β-endorphins.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oral group | Active Comparator | the patients will receive oral amantadine sulfate using the dose 100 mg 90 minute prior to the surgery and infusion of100cm I.V saline |
|
| I.V group | Active Comparator | the patients will receive 100 mg I.V amantadine sulfate infusion over 60minute prior to the surgery and placebo tablet 90 minute prior to the surgery |
|
| control group (group C) | Placebo Comparator | the patients will receive placebo tablet 90 minute prior to the surgery and infusion of 100cm I.V saline over 60minute prior to the surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral Amantadine sulfate | Drug | oral amantadine |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| the effect of oral amantadine versus IV amantadine premedication on laryngoscopy and tracheal intubation on β-endorphins . | changes of the mean arterial blood pressure (mmhg) | baseline( before medication) , 5 minutes before induction of anaesthesia, 3 minutes after induction , 5 minutes after tracheal intubation and 5 minutes after skin incision |
| Measure | Description | Time Frame |
|---|---|---|
| the effect of oral amantadine versus IV amantadine premedication on the hemodynamic response to surgical incision | β-endorphins level in the blood | 2 blood samples one just before medication and the second after 10 minutes after skin incision |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ghada Abu El Fadl, MD | Contact | 01005802086 | ghadafadl77@gmail.com | |
| amani abd elwahab, MD | Contact | 01004610623 | amanihassan1978@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Ghada Abu El Fadl, MD | Assiut, Assiut governorate, Egypt, 715715 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut university hospitals | Recruiting | Asyut | Egypt |
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| ID | Term |
|---|---|
| D000547 | Amantadine |
| ID | Term |
|---|---|
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
| i.v Amantadine Sulfate | Drug | intra venous amantadine |
|
|
| placebo tablet | Drug | placebo tablet |
|
| D009930 |
| Organic Chemicals |