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Completed

NCT Number: NCT02390817

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

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.

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Key information

Conditions

Spinal Curvatures Bone Diseases Musculoskeletal Diseases Spinal Diseases

Age range

10 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ebru Biricik, Adana, Sarıçam, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sugammadex

Drug

Administration of Sugammadex

Other names: group I

Neostigmine

Drug

Administration of Neostigmine

Other names: group II

Primary outcomes

  1. Time to consciousness

    Time frame: 30 min

    time to obeying verbal commands after reversal of NMBAs

Secondary outcomes

  1. To assess Motor Evoked Potential values

    Time frame: 4 hours

    Motor Evoked Potential (MEP)

  2. To assess Somatosensorial Evoked Potential values

    Time frame: 4 hours

    Somatosensorial Evoked Potential (SSEP)

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Collaborators

  • Private Ortopedia Hospital, Seyhan Adana

Registry information

Official study title

Effect of Sugammadex in Wakeup Procedure

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 18, 2015
Registry last updated
Mar 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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