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Amantadine Sulphate Usage in Spine Deformities Corrective Surgeries Patients

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ClinicalTrials.gov Identifier: NCT03178708
Recruitment Status : Completed
First Posted : June 7, 2017
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Ghada Mohammed AboelFadl, Assiut University

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
Spinal Curvatures 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 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.
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 : August 1, 2017
Actual Primary Completion Date : December 30, 2018
Actual Study Completion Date : December 30, 2018


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 Name: 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




Primary Outcome Measures :
  1. preoperative administration of amantadine sulphate on the amount of opioid consumption in postoperative period. [ Time Frame: 24 hours postoperative ]
    The effect of preoperative administration of amantadine sulphate on the amount of opioid consumption in postoperative period.


Secondary Outcome Measures :
  1. preoperative administration of amantadine sulphate on the duration of wake up test during major spine deformities corrective surgeries. [ Time Frame: At the time of the wake-up test during surgery 5-10 minutes ]
    Does amantadine Sulphate play a role in the duration of wake up test and opioid consumption in spine deformities corrective surgeries ?

  2. Pain assessment such as Numeric Rating Scale (N.R.C) [ Time Frame: 24 hours postoperative ]
    0=no pain,1-3=mild pain,4-6=moderate pain,7-10=severe pain



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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): NCT03178708


Locations
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Egypt
Assiut governorate
Assiut, Egypt
Sponsors and Collaborators
Assiut University

Publications of Results:
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Responsible Party: Ghada Mohammed AboelFadl, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03178708     History of Changes
Other Study ID Numbers: IV amantadine
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Amantadine
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
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