Oral Amantadine, IV Amantadine and Hemodynamic Response to Laryngoscopy

Sponsor

Assiut University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03612921

Collaborator

(none)

Enrollment

Location

Arms

43.5

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intubation, Intratracheal	Drug: oral Amantadine sulfate Drug: i.v Amantadine Sulfate Drug: placebo tablet	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Oral Amantadine Versus IV Amantadine to Attenuate the Hemodynamic Response to Laryngoscopy, Tracheal Intubation and Surgical Incision and Their Effect on β-endorphin: A Randomized Clinical Trial

Actual Study Start Date :

Aug 15, 2018

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Apr 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: oral group the patients will receive oral amantadine sulfate using the dose 100 mg 90 minute prior to the surgery and infusion of100cm I.V saline	Drug: oral Amantadine sulfate oral amantadine Other Names: amantadine
Active Comparator: I.V group 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	Drug: i.v Amantadine Sulfate intra venous amantadine Other Names: PK-Merz
Placebo Comparator: control group (group C) 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	Drug: placebo tablet placebo tablet

Arm

Intervention/Treatment

Active Comparator: oral group

the patients will receive oral amantadine sulfate using the dose 100 mg 90 minute prior to the surgery and infusion of100cm I.V saline

Drug: oral Amantadine sulfate

oral amantadine

Other Names:

amantadine

Active Comparator: I.V group

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

Drug: i.v Amantadine Sulfate

intra venous amantadine

Other Names:

PK-Merz

Placebo Comparator: control group (group C)

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

Drug: placebo tablet

placebo tablet

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut university hospitals	Assiut		Egypt

Sponsors and Collaborators

Assiut University

Investigators

Principal Investigator: Ghada Abu El Fadl, MD, Assiut, Assiut governorate, Egypt, 715715

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ghada Mohammed AboelFadl, Principal Investigator, Assiut University

ClinicalTrials.gov Identifier:

NCT03612921

Other Study ID Numbers:

17300205

First Posted:

Aug 2, 2018

Last Update Posted:

Nov 16, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ghada Mohammed AboelFadl, Principal Investigator, Assiut University

oral amantadine

IV amantadine

tracheal intubation

Additional relevant MeSH terms:

Amantadine

Study Results

No Results Posted as of Nov 16, 2021