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

Effect of Sugammadex in Wakeup Procedure

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02390817

Enrollment

Registered

2015-03-18

Start date

2015-03-31

Completion date

2017-08-31

Last updated

2018-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Curvatures

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.

Interventions

DRUGSugammadex

Administration of Sugammadex

DRUGNeostigmine

Administration of Neostigmine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

10 Years to 25 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Time to consciousness	30 min	time to obeying verbal commands after reversal of NMBAs

Secondary

Measure	Time frame	Description
To assess Motor Evoked Potential values	4 hours	Motor Evoked Potential (MEP)
To assess Somatosensorial Evoked Potential values	4 hours	Somatosensorial Evoked Potential (SSEP)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026