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

NCT ID: NCT02390817

Last Updated: 2018-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2017-08-31

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.

Conditions

Spinal Curvatures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Sugammadex

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

Group Type: ACTIVE_COMPARATOR

Sugammadex

Intervention Type: DRUG

Administration of Sugammadex

Neostigmine

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

Group Type: PLACEBO_COMPARATOR

Neostigmine

Intervention Type: DRUG

Administration of Neostigmine

Interventions

Sugammadex

Administration of Sugammadex

Intervention Type: DRUG

Neostigmine

Administration of Neostigmine

Intervention Type: DRUG

Other Intervention Names

group I; group II

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Private Ortopedia Hospital, Seyhan Adana

OTHER

Sponsor Role: collaborator

Cukurova University

OTHER

Sponsor Role: lead

Responsible Party

ebru biricik

Anesthesiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ebru Biricik

Role: STUDY_DIRECTOR

Medical Director

Locations

Ebru Biricik

Adana, Sarıçam, Turkey (Türkiye)

Çukurova University

Adana, Çukurova, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 21842171 (View on PubMed)

Related Links

http://pubmed.gov

full text

Other Identifiers

wakeup01

Identifier Type: -

Identifier Source: org_study_id