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

Effect of Sugammadex in Wakeup Procedure

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.

Study Overview

• Status: Completed
• Conditions: Spinal Curvatures
• Intervention / Treatment: Drug: Sugammadex; Drug: Neostigmine

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Sarıçam
    • Adana, Sarıçam, Turkey
      • Ebru Biricik
  • Çukurova
    • Adana, Çukurova, Turkey
      • Cukurova University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sugammadex; At the wakeup status Sugammadex 2 mg/kg single dose will perform.	Drug: Sugammadex; Administration of Sugammadex; Other Names: group I
Placebo Comparator: Neostigmine; At the wakeup status Neostigmine 0,04 mg/kg single dose will perform.	Drug: Neostigmine; Administration of Neostigmine; Other Names: group II

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cukurova University
• Collaborators: Private Ortopedia Hospital, Seyhan Adana
• Investigators: Study Director: Ebru Biricik, Medical Director

Publications and helpful links

General Publications

• 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.

Helpful Links

• full text

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: February 12, 2015
• First Submitted That Met QC Criteria: March 11, 2015
• First Posted (Estimate): March 18, 2015

Study Record Updates

• Last Update Posted (Actual): March 5, 2018
• Last Update Submitted That Met QC Criteria: March 2, 2018
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Cholinesterase Inhibitors; Parasympathomimetics; Neostigmine
• Other Study ID Numbers: wakeup01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No