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Neuromuscular Blockade for Optimising Surgical Conditions During Spinal Surgery

NCT02778945 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-04-01

No results posted yet for this study

Summary

In the present study, the investigators compare intermediate and deep NMB i.e. the two extreme regimes of muscle paralysis (neuromuscular block; NMB), (I) patients receiving intermediate muscle paralysis (''control, conventional NMB'') versus (II) patients with a deep neuromuscular blockade with rocuronium (''Deep NMB''), will be compared during a surgical procedure which is considered to be very sensitive for inadequate muscle relaxation, elective minimally invasive spinal surgery.

The primary objective of this trial is to compare the operation time reduction with the help of the decreased stiffness of targeted back muscle surrounding the surgical field.

The changed back muscle stiffness also measured as secondary objective goal by a mechanical tension weighing scale and also taking ultrasonography using shear wave elastography (SWE).

Other observational objectives are divided into the following categories of stakeholders: patients, surgeons and anesthesiologists', done by collecting the variety of clinical parameters. The following will be collected and compared.

1. For patients Intraoperative radiation amount, post-anesthetic care unit(PACU) stay, transfer rate to SICU for post-op. care, post-operative respiratory complication rate, and total hospital costs.
2. For surgeons Post-operative complications in regard to operation field, and evaluate surgical conditions using a Visual Analogue Scale(VAS score) in surgeon's side.
3. For anesthesiologists Intraoperative ventilation parameters of patients, and evaluate surgical conditions using a Visual Analogue Scale(VAS score) in anesthesiologist's side.

Conditions

  • Neuromuscular Block
  • Orthopedic Disorder of Spine
  • Muscle Weakness

Interventions

DRUG

Rocuronium 0.9 mg/kg

Neuromuscular block with Rocuronium 0.9 mg/kg for anesthetic induction Infusion of Rocuronium 0.3mg/kg/hr titrated to maintain a post-tetanic count (PTC)0-2 during the operation.

DRUG

Rocuronium 0.6 mg/kg

Neuromuscular block with Rocuronium 0.6 mg/kg for anesthetic induction Intermittent bolus i.v injection of Rocuronium 0.15mg/kg for train-of-four (TOF) 1-2 during the operation

Sponsors & Collaborators

  • The Catholic University of Korea

    lead OTHER

Principal Investigators

  • Jin Young Chon, M.D., Ph.D. · Department of Anesthesiology and pain medicine, Yeouido St. Mary's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-01
Primary Completion
2019-03-28
Completion
2019-05-01

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02778945 on ClinicalTrials.gov