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

Spinal Curvatures Clinical Trial

Official title:

Effect of Sugammadex in Wakeup Procedure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02390817
• Other study ID #: wakeup01
• Status: Completed
• Phase: Phase 4
• First received: February 12, 2015
• Last updated: March 2, 2018
• Start date: March 2015
• Est. completion date: August 2017

Study information

• Verified date: October 2016
• Source: Cukurova University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Curvatures

Intervention

Drug:
• Sugammadex
Administration of Sugammadex
• Neostigmine
Administration of Neostigmine

Locations

Country	Name	City	State
Turkey	Çukurova University	Adana	Çukurova
Turkey	Ebru Biricik	Adana	Sariçam

Sponsors (2)

Lead Sponsor	Collaborator
Cukurova University	Ortopedia Hospital

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to consciousness	time to obeying verbal commands after reversal of NMBAs	30 min
Secondary	To assess Motor Evoked Potential values	Motor Evoked Potential (MEP)	4 hours
Secondary	To assess Somatosensorial Evoked Potential values	Somatosensorial Evoked Potential (SSEP)	4 hours

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