Effect of Sugammadex for Muscle Motor Response and Awareness in Intraoperative Wakeup
Primary Purpose
Spinal Curvatures
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Sugammadex
Neostigmine
Sponsored by
About this trial
This is an interventional screening trial for Spinal Curvatures
Eligibility Criteria
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
Sites / Locations
- Ebru Biricik
- Çukurova University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Sugammadex
Neostigmine
Arm Description
At the wakeup status Sugammadex 2 mg/kg single dose will perform.
At the wakeup status Neostigmine 0,04 mg/kg single dose will perform.
Outcomes
Primary Outcome Measures
Time to consciousness
time to obeying verbal commands after reversal of NMBAs
Secondary Outcome Measures
To assess Motor Evoked Potential values
Motor Evoked Potential (MEP)
To assess Somatosensorial Evoked Potential values
Somatosensorial Evoked Potential (SSEP)
Full Information
NCT ID
NCT02390817
First Posted
February 12, 2015
Last Updated
March 2, 2018
Sponsor
Cukurova University
Collaborators
Private Ortopedia Hospital, Seyhan Adana
1. Study Identification
Unique Protocol Identification Number
NCT02390817
Brief Title
Effect of Sugammadex for Muscle Motor Response and Awareness in Intraoperative Wakeup
Official Title
Effect of Sugammadex in Wakeup Procedure
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University
Collaborators
Private Ortopedia Hospital, Seyhan Adana
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Curvatures
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sugammadex
Arm Type
Active Comparator
Arm Description
At the wakeup status Sugammadex 2 mg/kg single dose will perform.
Arm Title
Neostigmine
Arm Type
Placebo Comparator
Arm Description
At the wakeup status Neostigmine 0,04 mg/kg single dose will perform.
Intervention Type
Drug
Intervention Name(s)
Sugammadex
Other Intervention Name(s)
group I
Intervention Description
Administration of Sugammadex
Intervention Type
Drug
Intervention Name(s)
Neostigmine
Other Intervention Name(s)
group II
Intervention Description
Administration of Neostigmine
Primary Outcome Measure Information:
Title
Time to consciousness
Description
time to obeying verbal commands after reversal of NMBAs
Time Frame
30 min
Secondary Outcome Measure Information:
Title
To assess Motor Evoked Potential values
Description
Motor Evoked Potential (MEP)
Time Frame
4 hours
Title
To assess Somatosensorial Evoked Potential values
Description
Somatosensorial Evoked Potential (SSEP)
Time Frame
4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebru Biricik
Organizational Affiliation
Medical Director
Official's Role
Study Director
Facility Information:
Facility Name
Ebru Biricik
City
Adana
State/Province
Sarıçam
Country
Turkey
Facility Name
Çukurova University
City
Adana
State/Province
Çukurova
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21842171
Citation
Adamus M, Hrabalek L, Wanek T, Gabrhelik T, Zapletalova J. Intraoperative reversal of neuromuscular block with sugammadex or neostigmine during extreme lateral interbody fusion, a novel technique for spine surgery. J Anesth. 2011 Oct;25(5):716-20. doi: 10.1007/s00540-011-1209-1. Epub 2011 Aug 13.
Results Reference
background
Links:
URL
http://pubmed.gov
Description
full text
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Effect of Sugammadex for Muscle Motor Response and Awareness in Intraoperative Wakeup
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