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Paraspinal Muscle Relaxation in Spine Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03318718
Acronym
TOF
Enrollment
25
Registered
2017-10-24
Start date
2016-02-01
Completion date
2018-12-21
Last updated
2019-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paraspinal Muscle Relaxation in Spine Surgery

Brief summary

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.

Detailed description

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.

Interventions

DRUGAnesthesia with non-depolarizing NMBA Rocuronium

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.

DIAGNOSTIC_TESTTOF measurement

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

DIAGNOSTIC_TESTMEP measurement

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.

Sponsors

Balgrist University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
assessment of NMBA blockadeduring surgeryassessment of the NMBA (neuromuscular blocking agent) blockade by measurement of the amplitude of compound muscle action potential (CMAP)
MEPduring surgeryMotor evoked potentials (MEPs) are measured in hand, foot and paraspinal musculature
TOFduring surgerypeak-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

MeasureTime frameDescription
necessary administered amount of NMBAduring surgeryDifference in the necessary administered amount of NMBA to achieve full muscle relaxation for hand and foot versus paraspinal musculature

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026