Amantadine Sulphate Usage in Spine Deformities Corrective Surgeries Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2019-12-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Spinal Curvatures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Group A amantadine sulfate

Intervention Type DRUG

infusion solution for slowly intravenous application 3 hours preoperative

Group B ringer lactate

the patients will receive 500 ml ringer lactate infusion slowly i.v 3 hours prior to surgery.

Group Type PLACEBO_COMPARATOR

Group B ringer lactate

Intervention Type OTHER

infusion solution for intravenous application 3 hours preoperative

Interventions

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Group A amantadine sulfate

infusion solution for slowly intravenous application 3 hours preoperative

Intervention Type DRUG

Group B ringer lactate

infusion solution for intravenous application 3 hours preoperative

Intervention Type OTHER

Other Intervention Names

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PK-Merz Infusion amantadine sulfate ringer lactate Lactated ringer

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No