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Amantadine Sulphate Usage in Spine Deformities Corrective Surgeries Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03178708
Recruitment Status : Completed
First Posted : June 7, 2017
Last Update Posted : July 15, 2020
Sponsor:
Information provided by (Responsible Party):
Ghada Mohammed AboelFadl, Assiut University

Tracking Information
First Submitted Date  ICMJE June 3, 2017
First Posted Date  ICMJE June 7, 2017
Last Update Posted Date July 15, 2020
Actual Study Start Date  ICMJE August 1, 2017
Actual Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2020)
Pain assessment such as Visual Analogue Scale (VAS) [ Time Frame: 24 hours postoperative ]
0=no pain,1-3=mild pain,4-6=moderate pain,7-10=severe pain
Original Primary Outcome Measures  ICMJE
 (submitted: June 5, 2017)
  • 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 ?
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2020)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2017)
  • Pain assessment [ Time Frame: 24 hours postoperative ]
    Pain assessment such as visual analogue scale for pain at rest and when moving in bed.
  • Opioid related side effects [ Time Frame: 24 hours postoperative ]
    Opioid related side effects (nausea and /or vomiting and the need for alizapride 50 mg i.v )
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Amantadine Sulphate Usage in Spine Deformities Corrective Surgeries Patients
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE 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
Condition  ICMJE Spinal Curvatures
Intervention  ICMJE
  • Drug: Group A amantadine sulfate
    infusion solution for slowly intravenous application 3 hours preoperative
    Other Name: PK-Merz Infusion amantadine sulfate
  • Other: Group B ringer lactate
    infusion solution for intravenous application 3 hours preoperative
    Other Names:
    • ringer lactate
    • Lactated ringer
Study Arms  ICMJE
  • 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
    Intervention: Drug: Group A 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.
    Intervention: Other: Group B ringer lactate
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 21, 2020)
60
Original Estimated Enrollment  ICMJE
 (submitted: June 5, 2017)
40
Actual Study Completion Date  ICMJE December 30, 2019
Actual Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03178708
Other Study ID Numbers  ICMJE IV amantadine
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ghada Mohammed AboelFadl, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assiut University
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP