Amantadine Sulphate Usage in Spine Deformities Corrective Surgeries Patients
Primary Purpose
Spinal Curvatures
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Group A amantadine sulfate
Group B ringer lactate
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Curvatures
Eligibility Criteria
Inclusion Criteria:
- Being candidate for spine deformity correction surgery(scoliosis and kyphosis )
- Willing to participate in the study
Exclusion Criteria:
- Patient refusal
- Patients 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)
Sites / Locations
- Assiut governorate
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Group A amantadine sulfate
Group B ringer lactate
Arm Description
the patients will receive amantadine sulfate infusion using the dose 200 mg slowly I.V 3 hours prior to the surgery
the patients will receive 500 ml ringer lactate infusion slowly i.v 3 hours prior to surgery.
Outcomes
Primary Outcome Measures
postoperative opioid consumption
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03178708
Brief Title
Amantadine Sulphate Usage in Spine Deformities Corrective Surgeries Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Curvatures
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
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
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A amantadine sulfate
Arm Type
Active Comparator
Arm Description
the patients will receive amantadine sulfate infusion using the dose 200 mg slowly I.V 3 hours prior to the surgery
Arm Title
Group B ringer lactate
Arm Type
Placebo Comparator
Arm Description
the patients will receive 500 ml ringer lactate infusion slowly i.v 3 hours prior to surgery.
Intervention Type
Drug
Intervention Name(s)
Group A amantadine sulfate
Other Intervention Name(s)
PK-Merz Infusion amantadine sulfate
Intervention Description
infusion solution for slowly intravenous application 3 hours preoperative
Intervention Type
Other
Intervention Name(s)
Group B ringer lactate
Other Intervention Name(s)
ringer lactate, Lactated ringer
Intervention Description
infusion solution for intravenous application 3 hours preoperative
Primary Outcome Measure Information:
Title
postoperative opioid consumption
Time Frame
24 hours postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Being candidate for spine deformity correction surgery(scoliosis and kyphosis )
Willing to participate in the study
Exclusion Criteria:
Patient refusal
Patients 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)
Facility Information:
Facility Name
Assiut governorate
City
Assiut
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
14695734
Citation
Snijdelaar DG, Koren G, Katz J. Effects of perioperative oral amantadine on postoperative pain and morphine consumption in patients after radical prostatectomy: results of a preliminary study. Anesthesiology. 2004 Jan;100(1):134-41. doi: 10.1097/00000542-200401000-00022.
Results Reference
result
PubMed Identifier
16996315
Citation
Eisenberg E, Pud D, Koltun L, Loven D. Effect of early administration of the N-methyl-d-aspartate receptor antagonist amantadine on the development of postmastectomy pain syndrome: a prospective pilot study. J Pain. 2007 Mar;8(3):223-9. doi: 10.1016/j.jpain.2006.08.003. Epub 2006 Sep 22.
Results Reference
result
PubMed Identifier
18456219
Citation
Gerner P. Postthoracotomy pain management problems. Anesthesiol Clin. 2008 Jun;26(2):355-67, vii. doi: 10.1016/j.anclin.2008.01.007.
Results Reference
result
PubMed Identifier
20609131
Citation
Singla N, Rock A, Pavliv L. A multi-center, randomized, double-blind placebo-controlled trial of intravenous-ibuprofen (IV-ibuprofen) for treatment of pain in post-operative orthopedic adult patients. Pain Med. 2010 Aug;11(8):1284-93. doi: 10.1111/j.1526-4637.2010.00896.x. Epub 2010 Jun 30.
Results Reference
result
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Amantadine Sulphate Usage in Spine Deformities Corrective Surgeries Patients
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