NCT02390817

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

Effect of Sugammadex in Wakeup Procedure

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Cukurova University · Academic / Other
• Sex: All
• Age: 10 Years – 25 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Sugammadex	Administration of Sugammadex
DRUG	Neostigmine	Administration of Neostigmine

Timeline

• Start date: 2015-03-01
• Primary completion: 2017-08-01
• Completion: 2017-08-01
• First posted: 2015-03-18
• Last updated: 2018-03-05

Locations

2 sites across 1 country: Turkey (Türkiye)