Amantadine Sulphate Usage in Spine Deformities Corrective Surgeries Patients

Spinal Curvatures Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03178708
• Other study ID #: IV amantadine
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 1, 2017
• Est. completion date: December 30, 2019

Study information

• Verified date: January 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Spinal Curvatures

Intervention

Drug:
• Group A amantadine sulfate
infusion solution for slowly intravenous application 3 hours preoperative

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

Locations

Country	Name	City	State
Egypt	Assiut governorate	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View Citation

Gerner P. Postthoracotomy pain management problems. Anesthesiol Clin. 2008 Jun;26(2):355-67, vii. doi: 10.1016/j.anclin.2008.01.007. Review. — View 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- — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative opioid consumption		24 hours postoperative