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Completed

NCT Number: NCT03178708

Amantadine Sulphate Usage in Spine Deformities Corrective Surgeries Patients

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.

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Key information

Conditions

Spinal Curvatures Bone Diseases Musculoskeletal Diseases Spinal Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Assiut governorate

Asyut, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Group A amantadine sulfate

Drug

infusion solution for slowly intravenous application 3 hours preoperative

Other names: PK-Merz Infusion amantadine sulfate

Group B ringer lactate

Other

infusion solution for intravenous application 3 hours preoperative

Other names: ringer lactate, Lactated ringer

Primary outcomes

  1. postoperative opioid consumption

    Time frame: 24 hours postoperative

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 7, 2017
Registry last updated
Jan 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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