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Completed

NCT Number: NCT03318718

Paraspinal Muscle Relaxation in Spine Surgery

During anesthesia, neuromuscular blocking agents (NMBA) are routinely used for relaxation of muscles necessary for the conduction of the surgical procedure. Train-of-four (TOF) test is based on supramaximal stimulation of peripheral nerve resulting in four twitches: T1 to T4. The assessment of the NMBA blockade is performed routinely by measurement of the amplitude of compound muscle action potential (CMAP) and calculation of percentage of CMAP decrement from T1 to T4.

Train-of-four monitoring is routinely performed during spine surgery by stimulation of the ulnar nerve. Furthermore motor evoked potentials (MEPs) are routinely used in intraoperative neuromonitoring to assess the whole motor pathway from the cortical level down to the distal muscle. During anesthesia MEPs are routinely evoked by transcranial electrical stimulation with single or short train stimuli. In clinical practice even though full muscle relaxation of the hand by NMBA can be observed, utilizing the TOF test, remaining muscle tonus can be observed at the paraspinal musculature during spine surgery.

The goals of this study are to determine (1) if any differences between muscle relaxation of the hand and foot (measured by TOF test and MEPs) and MEPs of the paraspinal musculature occur; (2) how much more NMBA must be administered to achieve full muscle relaxation of the paraspinal musculature in comparison to the hand or foot.

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Key information

Conditions

Paraspinal Muscle Relaxation in Spine Surgery

Age range

14 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Balgrist

Zurich, Canton of Zurich, 8008, Switzerland

About this study

Muscle relaxation during surgery will be performed using intraoperative boli intermediate duration non-depolarizing NMBA, rocuronium (0.3 mg/kg) until TOF 0 at the hand is achieved. TOF measurements will be performed at baseline 5 minutes after induction. Moreover, TOF measurements will be performed 5 minutes after each rocuronium bolus. When TOF 0 at the hand is achieved the MEPs of the paraspinal musculature will be measured. When there is remaining muscle tonus of the paraspinal musculature another bolus of rocuronium is administered until no MEPs can be measured for the paraspinal musculature.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients that will undergo spinal surgery with intraoperative neurophysiological Monitoring
  • Age: 14 - 99 years

Exclusion criteria

  • No intraoperative neurophysiological Monitoring
  • Age <14 year
  • prior neurological diseases or deficits that may affect safety of surgery/Intraoperative neuromonitoring
  • No informed consent

Treatment and study plan

Anesthesia with non-depolarizing NMBA Rocuronium

Drug

Non- depolarizing NMBA Rocuronium will be used until full paraspinal muscle Relaxation. Muscle relaxation during surgery will be performed using intraoperative boli intermediate duration non-depolarizing NMBA, rocuronium (0.3 mg/kg) until good surgical conditions are achieved.

TOF measurement

Diagnostic Test

TOF (Train-of-four) measurements will be performed at baseline 5 minutes after induction after the effect of succinylcholine will have run off. Moreover, TOF measurements will be performed 5 minutes after each rocuronium bolus

MEP measurement

Diagnostic Test

MEPs (motor evoked potentials) are routinely obtained after intubation and before surgery, then every 10min during the critical preparation and closing phases of surgery and every 5min during the correction phase. In addition MEPs will be measured after the administration of the NMBA rocuronium. Baseline values for amplitudes and latencies are obtained directly prior to the start of the correction phase of the surgery.

Primary outcomes

  1. assessment of NMBA blockade

    Time frame: during surgery

    assessment of the NMBA (neuromuscular blocking agent) blockade by measurement of the amplitude of compound muscle action potential (CMAP)

  2. MEP

    Time frame: during surgery

    Motor evoked potentials (MEPs) are measured in hand, foot and paraspinal musculature

  3. TOF

    Time frame: during surgery

    peak-to-peak amplitude of CMAP for each of 4 muscle contractions is measured. (supramaximal stimulation of peripheral nerve results in four twitches: T1 to T4)

Secondary outcomes

  1. necessary administered amount of NMBA

    Time frame: during surgery

    Difference in the necessary administered amount of NMBA to achieve full muscle relaxation for hand and foot versus paraspinal musculature

Sponsors and collaborators

Lead sponsor

Balgrist University Hospital

Other

Registry information

Official study title

Paraspinal Muscle Relaxation in Spine Surgery: Comparison of the Effect of Neuromuscular Blocking Agent Rocuronium Between Extremity- and Paraspinal Musculature

Acronym: TOF

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 24, 2017
Registry last updated
Feb 18, 2019

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.