Oral Amantadine, IV Amantadine and Hemodynamic Response to Laryngoscopy

Phase 2

• Conditions: Intubation, Intratracheal
• Interventions: Drug: placebo tablet; Drug: i.v Amantadine Sulfate; Drug: oral Amantadine sulfate

• Registration Number: NCT03612921
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study First Submitted: 2018-05-16
• Study First Submitted QC: 2018-08-01
• Study First Posted: 2018-08-02
• Study Start: 2018-08-15
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-12
• Last Update Posted: 2021-11-16
• Primary Completion: 2022-03-01
• Study Completion: 2022-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• ASA I&II
• the age range 20-55 years scheduled for elective back surgery(laminectomy, discectomy and spinal canal stenosis)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group (group C)	placebo tablet	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
I.V group	i.v Amantadine Sulfate	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
oral group	oral Amantadine sulfate	the patients will receive oral amantadine sulfate using the dose 100 mg 90 minute prior to the surgery and infusion of100cm I.V saline

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Assiut university hospitals; 🇪🇬 Assiut, Egypt