Effect of Sugammadex for Muscle Motor Response and Awareness in Intraoperative Wakeup

Study Overview
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Brief Summary
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The study will be performed to evaluate motor response and awareness with using sugammadex during wakeup procedure in spine surgery. The investigator's goal is to investigate the effect of sugammadex on the state of consciousness and motor-somatosensorial evoked potentials.

Detailed Description
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Between 10-25 age, American Society of Anesthesiologist clinical status(ASA) I-II, 60 patient which will be performed spine surgery in orthopedics clinic will be enrolled in this study. Patient will be randomized into two group that include 20 patient. General anesthesia will be administered by Totally intravenous anesthesia (TIVA) with propofol and remifentanyl for all patients. Two groups will be monitored with BIS (bispectral index), TOF (train-of-for) MEP (motor evoked potential) and SSEP (somatosensorial potential). During wakeup procedure, in group S, TIVA will be stopped and 2 mg/kg of sugammadex will be given intravenously. BIS, TOF, MEP, SSEP will be measured. In group N, TIVA will be stopped and 0.04 mg/kg of neostigmine will be given. Also BIS, TOF, MEP, SSEP will be measured. Sugammadex will be given group S and Neostigmine will be given group N at the end of the operation. At postoperative sixth hour, the investigators will visit all the patients and ask standard questions about intraoperative wakeup procedure.

Official Title
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Effect of Sugammadex in Wakeup Procedure

Conditions
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Spinal Curvatures

Intervention / Treatment
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* Drug: Sugammadex
* Drug: Neostigmine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American society of anesthesiologists (ASA) physical status I-II patients spine surgery 10-25 age Exclusion Criteria: ASA III and above Patient refusal neuromuscular disease

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sugammadex<br>At the wakeup status Sugammadex 2 mg/kg single dose will perform. | Drug: Sugammadex<br>* Administration of Sugammadex<br>* Other names: group I;|
| Placebo Comparator: Neostigmine<br>At the wakeup status Neostigmine 0,04 mg/kg single dose will perform. | Drug: Neostigmine<br>* Administration of Neostigmine<br>* Other names: group II;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to consciousness | time to obeying verbal commands after reversal of NMBAs | 30 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess Motor Evoked Potential values | Motor Evoked Potential (MEP) | 4 hours | 
| To assess Somatosensorial Evoked Potential values | Somatosensorial Evoked Potential (SSEP) | 4 hours |