Intubation, Intratracheal
Conditions
Keywords
oral amantadine, IV amantadine, tracheal intubation
Brief summary
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.
Detailed description
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.
Interventions
oral amantadine
DRUGi.v Amantadine Sulfate
intra venous amantadine
DRUGplacebo tablet
placebo tablet
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* ASA I&II * the age range 20-55 years scheduled for elective back surgery(laminectomy, discectomy and spinal canal stenosis)
Exclusion criteria
* Patient refusal * Patients with ASA score III (with chronic kidney, lungs, Gastrointestinal tract, liver, or cardiovascular diseases) * Pregnant or breastfeeding women. * Allergy to any of the study medications and taking medications that could significantly interact with amantadine (tramadol, atropine, antipsychotic medications) * DM, thyroid disease any endocrine disease * Suspected difficult intubation or intubation time more than 30 second.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the effect of oral amantadine versus IV amantadine premedication on laryngoscopy and tracheal intubation on β-endorphins . | baseline( before medication) , 5 minutes before induction of anaesthesia, 3 minutes after induction , 5 minutes after tracheal intubation and 5 minutes after skin incision | changes of the mean arterial blood pressure (mmhg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the effect of oral amantadine versus IV amantadine premedication on the hemodynamic response to surgical incision | 2 blood samples one just before medication and the second after 10 minutes after skin incision | β-endorphins level in the blood |
Countries
Egypt
Contacts
Primary ContactGhada Abu El Fadl, MD
Backup Contactamani abd elwahab, MD
Outcome results
None listed