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

Sponsor

Cukurova University (Other)

Overall Status

Completed

CT.gov ID

NCT02390817

Collaborator

Private Ortopedia Hospital, Seyhan Adana (Other)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Curvatures	Drug: Sugammadex Drug: Neostigmine	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Screening

Official Title:

Effect of Sugammadex in Wakeup Procedure

Study Start Date :

Mar 1, 2015

Actual Primary Completion Date :

Aug 1, 2017

Actual Study Completion Date :

Aug 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Sugammadex At the wakeup status Sugammadex 2 mg/kg single dose will perform.	Drug: Sugammadex Administration of Sugammadex Other Names: group I
Placebo Comparator: Neostigmine At the wakeup status Neostigmine 0,04 mg/kg single dose will perform.	Drug: Neostigmine Administration of Neostigmine Other Names: group II

Arm

Intervention/Treatment

Active Comparator: Sugammadex

At the wakeup status Sugammadex 2 mg/kg single dose will perform.

Drug: Sugammadex

Administration of Sugammadex

Other Names:

group I

Placebo Comparator: Neostigmine

At the wakeup status Neostigmine 0,04 mg/kg single dose will perform.

Drug: Neostigmine

Administration of Neostigmine

Other Names:

group II

Outcome Measures

Primary Outcome Measures

Time to consciousness [30 min]
time to obeying verbal commands after reversal of NMBAs

Secondary Outcome Measures

To assess Motor Evoked Potential values [4 hours]
Motor Evoked Potential (MEP)
To assess Somatosensorial Evoked Potential values [4 hours]
Somatosensorial Evoked Potential (SSEP)

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ebru Biricik	Adana	Sarıçam	Turkey
2	Çukurova University	Adana	Çukurova	Turkey

Sponsors and Collaborators

Cukurova University
Private Ortopedia Hospital, Seyhan Adana

Investigators

Study Director: Ebru Biricik, Medical Director

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

full text

Publications

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.

Responsible Party:

ebru biricik, Anesthesiologist, Cukurova University

ClinicalTrials.gov Identifier:

NCT02390817

Other Study ID Numbers:

wakeup01

First Posted:

Mar 18, 2015

Last Update Posted:

Mar 5, 2018

Last Verified:

Oct 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Spinal Curvatures

Neostigmine

Study Results

No Results Posted as of Mar 5, 2018