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

Phase 4

Completed

• Conditions: Spinal Curvatures
• Interventions: Drug: Sugammadex; Drug: Neostigmine

• Registration Number: NCT02390817
• Lead Sponsor: Cukurova University

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.

Study Timeline

• Study First Submitted: 2015-02-12
• Study Start: 2015-03
• Study First Submitted QC: 2015-03-11
• Study First Posted: 2015-03-18
• Status Verified: 2016-10
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Last Update Submitted: 2018-03-02
• Last Update Posted: 2018-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugammadex	Sugammadex	At the wakeup status Sugammadex 2 mg/kg single dose will perform.
Neostigmine	Neostigmine	At the wakeup status Neostigmine 0,04 mg/kg single dose will perform.

Primary Outcome Measures

Name	Time	Method
Time to consciousness	30 min	time to obeying verbal commands after reversal of NMBAs

Secondary Outcome Measures

Name	Time	Method
To assess Motor Evoked Potential values	4 hours	Motor Evoked Potential (MEP)
To assess Somatosensorial Evoked Potential values	4 hours	Somatosensorial Evoked Potential (SSEP)

Trial Locations

Locations (2)

Ebru Biricik; 🇹🇷 Adana, Sarıçam, Turkey

Çukurova University; 🇹🇷 Adana, Çukurova, Turkey