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Amantadine Sulphate Usage in Spine Deformities Corrective Surgeries Patients

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT03178708
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
28.9
Actual Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

During the surgical procedure of scoliosis correction, large surgery extent and long-lasting strong nociceptive stimulation lead to postoperative pain formation of greater intensity compared with other orthopedic interventions. In these patients, duration of postoperative symptoms is longer, and may lead to persistent pain formation due to developing neuroplastic changes in the central nervous system.

Condition or Disease Intervention/Treatment Phase
  • Drug: Group A amantadine sulfate
  • Other: Group B ringer lactate
 Phase 2/Phase 3

Detailed Description

Instrumentation in correction operations for spinal deformities as vertebral fusion, congenital and traumatic scoliosis, carries a 0.5-5% risk of injuring the spinal cord during spinal surgery.

These complications are generally results of complex factors such as direct effects of compression on the spinal cord, distraction, the effects of spinal ischemia or arterial hypotension.

The purpose of the wake-up test is to monitor voluntary motor function of the lower limbs once the vertebrae have been instrumented and distracted. The depth of anesthesia is gradually lightened up to the point where patients are able to respond to verbal commands. As the voluntary movement of lower extremities is demonstrated, the depth of anesthesia is increased to complete the surgery.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
the role of preoperative administration of Amantadine Sulphate on the duration of wake up test and postoperative opiod consumption in patients undergoing major spine deformities corrective surgeries.the role of preoperative administration of Amantadine Sulphate on the duration of wake up test and postoperative opiod consumption in patients undergoing major spine deformities corrective surgeries.
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
The Implications of Amantadine Sulphate Usage in Spine Deformities Corrective Surgeries Patients as Regard Its Effect on the Duration of Wake up Test and Postoperative Opioid Consumption
Actual Study Start Date :
Aug 1, 2017
Actual Primary Completion Date :
Dec 30, 2019
Actual Study Completion Date :
Dec 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group A amantadine sulfate

the patients will receive amantadine sulfate infusion using the dose 200 mg slowly I.V 3 hours prior to the surgery

Drug: Group A amantadine sulfate
infusion solution for slowly intravenous application 3 hours preoperative
Other Names:
  • PK-Merz Infusion amantadine sulfate

    		•
    Placebo Comparator: Group B ringer lactate

    the patients will receive 500 ml ringer lactate infusion slowly i.v 3 hours prior to surgery.

    Other: Group B ringer lactate
    infusion solution for intravenous application 3 hours preoperative
    Other Names:
  • ringer lactate
  • Lactated ringer

    		•

    Outcome Measures

    Primary Outcome Measures

    1. postoperative opioid consumption [24 hours postoperative]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Being candidate for spine deformity correction surgery(scoliosis and kyphosis )

    2. Willing to participate in the study

    Exclusion Criteria:

    1. Patient refusal

    2. Patients with chronic kidney, lungs,Gastrointestinal tract, liver, or cardiovascular diseases.

    3. Pregnant or breastfeeding women.

    4. Allergy to any of the study medications and taking medications that could significantly interact with amantadine (tramadol, atropine,antipsychotic medications)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut governorate Assiut Egypt

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ghada Mohammed AboelFadl, Principal Investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT03178708
    Other Study ID Numbers:
    • IV amantadine
    First Posted:
    Jun 7, 2017
    Last Update Posted:
    Jan 12, 2021
    Last Verified:
    Jan 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Spinal Curvatures
    Amantadine

    Study Results

    No Results Posted as of Jan 12, 2021