Oral Amantadine, IV Amantadine and Hemodynamic Response to Laryngoscopy

NCT03612921 | Unknown Phase 2

• 1 other identifier: 17300205
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation, Intratracheal

Keywords

oral amantadine; IV amantadine; tracheal intubation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (3)

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

Drug: oral Amantadine sulfate

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

Drug: i.v Amantadine Sulfate

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

Drug: placebo tablet

Interventions

oral Amantadine sulfate DRUG

oral amantadine

Also known as: amantadine

oral group

i.v Amantadine Sulfate DRUG

intra venous amantadine

Also known as: PK-Merz

I.V group

placebo tablet DRUG

placebo tablet

control group (group C)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university hospitals

Asyut, Egypt

RECRUITING

MeSH Terms

Interventions

Amantadine

Intervention Hierarchy (Ancestors)

Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Ghada Abu El Fadl, MD

  Assiut, Assiut governorate, Egypt, 715715

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ghada Abu El Fadl, MD

CONTACT

01005802086; ghadafadl77@gmail.com

amani abd elwahab, MD

CONTACT

01004610623; amanihassan1978@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: August 2, 2018
• Study Start: August 15, 2018
• Primary Completion: March 1, 2022
• Study Completion: April 1, 2022
• Last Updated: November 16, 2021

Record last verified: 2021-11

Locations

EG (1)