Effect of Sugammadex for Muscle Motor Response and Awareness in Intraoperative Wakeup
Effect of Sugammadex in Wakeup Procedure
1 other identifier
interventional
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2015
Typical duration for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2015
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedFirst Posted
Study publicly available on registry
March 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedMarch 5, 2018
October 1, 2016
2.4 years
February 12, 2015
March 2, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Time to consciousness
time to obeying verbal commands after reversal of NMBAs
30 min
Secondary Outcomes (2)
To assess Motor Evoked Potential values
4 hours
To assess Somatosensorial Evoked Potential values
4 hours
Study Arms (2)
Sugammadex
ACTIVE COMPARATORAt the wakeup status Sugammadex 2 mg/kg single dose will perform.
Neostigmine
PLACEBO COMPARATORAt the wakeup status Neostigmine 0,04 mg/kg single dose will perform.
Interventions
Eligibility Criteria
You may qualify if:
- American society of anesthesiologists (ASA) physical status I-II patients
- spine surgery
- age
You may not qualify if:
- ASA III and above
- Patient refusal
- neuromuscular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cukurova Universitylead
- Private Ortopedia Hospital, Seyhan Adanacollaborator
Study Sites (2)
Ebru Biricik
Adana, Sarıçam, Turkey (Türkiye)
Çukurova University
Adana, Çukurova, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 21842171BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ebru Biricik
Medical Director
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Anesthesiologist
Study Record Dates
First Submitted
February 12, 2015
First Posted
March 18, 2015
Study Start
March 1, 2015
Primary Completion
August 1, 2017
Study Completion
August 1, 2017
Last Updated
March 5, 2018
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will not share