Amantadine Sulphate Usage in Spine Deformities Corrective Surgeries Patients

• ClinicalTrials.gov Identifier: NCT03178708
• Recruitment Status: Completed
• First Posted: June 7, 2017
• Last Update Posted: January 12, 2021
• Sponsor: Assiut University
• Information provided by (Responsible Party): Ghada Mohammed AboelFadl, Assiut University

Tracking Information

• First Submitted Date: June 3, 2017
• First Posted Date: June 7, 2017
• Last Update Posted Date: January 12, 2021
• Actual Study Start Date: August 1, 2017
• Actual Primary Completion Date: December 30, 2019 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 8, 2021): postoperative opioid consumption [ Time Frame: 24 hours postoperative ]

Original Primary Outcome Measures (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.

• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (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: 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
• 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: Interventional
• Study Phase: Phase 2; Phase 3

Study Design

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: Spinal Curvatures

Intervention

• 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

• 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 *

• 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.
• 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. Epub 2006 Sep 22.
• Gerner P. Postthoracotomy pain management problems. Anesthesiol Clin. 2008 Jun;26(2):355-67, vii. doi: 10.1016/j.anclin.2008.01.007. Review.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 21, 2020): 60
• Original Estimated Enrollment (submitted: June 5, 2017): 40
• Actual Study Completion Date: December 30, 2019
• Actual Primary Completion Date: December 30, 2019 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 40 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT03178708
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Ghada Mohammed AboelFadl, Assiut University
• Study Sponsor: Assiut University
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Assiut University
• Verification Date: January 2021