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

Çukurova University

Status and phase: Completed; Phase 4

Conditions: Spinal Curvatures

Treatments: Drug: Sugammadex; Drug: Neostigmine

Study type: Interventional

Funder types: Other

Identifiers

NCT02390817

wakeup01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 10 to 25 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

Sugammadex

Active Comparator group

Description:

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

Treatment:

Drug: Sugammadex

Neostigmine

Placebo Comparator group

Description:

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

Treatment:

Drug: Neostigmine