Oral Amantadine Versus Gabapentin to Attenuate the Response to Laryngoscopy and Tracheal Intubation

NCT03172234 | Completed Phase 2 DMC

• 1 other identifier: Assuit universty
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effect of oral amantadine versus gabapentin premedication on the hemodynamic response to laryngoscopy and tracheal intubation and their effect on β-endorphins.

Conditions

Effect of Laryngoscopy and Tracheal Intubation

Keywords

β-endorphins,laryngoscopy and tracheal intubation

Outcome Measures

Primary Outcomes (1)

• effect of oral amantadine versus gabapentin premedication on laryngoscopy and tracheal intubation on β-endorphins.

  analysis of change of β-endorphins in blood sample

  baseline blood sample taken before drug administration and after 15 minutes after intubation and before skin incision

Secondary Outcomes (2)

• effect of oral amantadine versus gabapentin premedication on the Mean arterial blood pressure due to laryngoscopy and tracheal intubation

  baselineMAP before drug administration and after 15 minutes after intubation and before skin incision

• effect of oral amantadine versus gabapentin premedication on the heart rate due to laryngoscopy and tracheal intubation

  baseline heart rate before drug administration and after 15 minutes after intubation and before skin incision

Study Arms (3)

amantadine group (Group A)

ACTIVE COMPARATOR

the patients will receive oral amantadine sulfate using the dose 100 mg 120 minutes prior to the surgery, 5 ml saline IV 5 minutes before intubation.

Other: oral amantadine sulfate

gabapentin group(Group B)

ACTIVE COMPARATOR

the patients will receive oral gabapentin using the dose 800 mg 120 minutes prior to surgery,5 ml saline IV 5 minutes before intubation.

Drug: oral gabapentin

control group (group C)

PLACEBO COMPARATOR

the patients will receive placebo oral tablet 120 minutes prior to surgery, IV fentanyl 2µ/kg in 5 ml saline 5 minutes before intubation.

Drug: Placebo Oral Tablet

Interventions

oral amantadine sulfate OTHER

In amantadine group:the patients will receive100 mg oral amantadine sulfate 90 minute prior to the surgery

Also known as: infex

amantadine group (Group A)

oral gabapentin DRUG

In gabapentin group: the patients will receive oral 800 mg gabapentin 90 minute prior to the surgery

Also known as: gabapentin

gabapentin group(Group B)

Placebo Oral Tablet DRUG

in control group : the patients will receive Placebo Oral Tablet 90 minute prior to the surgery

control group (group C)

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA I\&II scheduled for elective spine surgery

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)
• diabetes mellitus, thyroid disease any endocrine disease
• Suspected difficult intubation or intubation time more than 30 second.

Sponsors & Collaborators

• Ghada Mohammed AboelFadl: lead

Study Sites (1)

Assiut university hospitals

Asyut, Egypt

Location

MeSH Terms

Interventions

Amantadine; Gabapentin

Intervention Hierarchy (Ancestors)

Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Amines; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Abualauon Elpiplaoy, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

• Ahmed El shanawany, MD

  Assiut University

  STUDY CHAIR

• Azza Abo Elfadl El Sayed, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal-investigator

Study Record Dates

• First Submitted: May 20, 2017
• First Posted: June 1, 2017
• Study Start: June 15, 2017
• Primary Completion: May 15, 2018
• Study Completion: May 15, 2018
• Last Updated: September 25, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)