Amantadine Sulphate Usage in Spine Deformities Corrective Surgeries Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03178708|
Recruitment Status : Completed
First Posted : June 7, 2017
Last Update Posted : March 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Spinal Curvatures||Drug: Group A amantadine sulfate Other: Group B ringer lactate||Phase 2 Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||20 participants|
|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)|
|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|
|Actual Study Start Date :||August 1, 2017|
|Actual Primary Completion Date :||December 30, 2018|
|Actual Study Completion Date :||December 30, 2018|
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
Drug: Group A amantadine sulfate
infusion solution for slowly intravenous application 3 hours preoperative
Other Name: PK-Merz Infusion 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.
Other: Group B ringer lactate
infusion solution for intravenous application 3 hours preoperative
- 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.
- 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 ?
- Pain assessment such as Numeric Rating Scale (N.R.C) [ Time Frame: 24 hours postoperative ]0=no pain,1-3=mild pain,4-6=moderate pain,7-10=severe pain
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03178708