Amantadine Sulphate Usage in Spine Deformities Corrective Surgeries Patients

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03178708

Enrollment

Registered

2017-06-07

Start date

2017-08-01

Completion date

2019-12-30

Last updated

2021-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Curvatures

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.

Interventions

DRUGGroup A amantadine sulfate

infusion solution for slowly intravenous application 3 hours preoperative

OTHERGroup B ringer lactate

infusion solution for intravenous application 3 hours preoperative

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
postoperative opioid consumption	24 hours postoperative

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026