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Oral Amantadine, IV Amantadine and Hemodynamic Response to Laryngoscopy

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ClinicalTrials.gov Identifier: NCT03612921
Recruitment Status : Recruiting
First Posted : August 2, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Ghada Mohammed AboelFadl, 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.

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.

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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Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 15, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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




Primary Outcome Measures :
  1. the effect of oral amantadine versus IV amantadine premedication on laryngoscopy and tracheal intubation on β-endorphins . [ Time Frame: 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 :
  1. the effect of oral amantadine versus IV amantadine premedication on the hemodynamic response to surgical incision [ Time Frame: 2 blood samples one just before medication and the second after 10 minutes after skin incision ]
    β-endorphins level in the blood



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03612921


Contacts
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Contact: Ghada Abu El Fadl, MD 01005802086 ghadafadl77@gmail.com
Contact: amani abd elwahab, MD 01004610623 amanihassan1978@yahoo.com

Locations
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Egypt
Assiut university hospitals Recruiting
Assiut, Egypt
Contact: Ghada Abu El Fadl, MD    01005802086    ghadafadl77@gmail.com   
Contact: amani abd elwahabMD, MD    01004610623    amanihassan1976@yahoo.com   
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Ghada Abu El Fadl, MD Assiut, Assiut governorate, Egypt, 715715

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Responsible Party: Ghada Mohammed AboelFadl, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03612921     History of Changes
Other Study ID Numbers: 17300205
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ghada Mohammed AboelFadl, Assiut University:
oral amantadine
IV amantadine
tracheal intubation
Additional relevant MeSH terms:
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Amantadine
Antiparkinson Agents
Anti-Dyskinesia Agents
Antiviral Agents
Anti-Infective Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents