Neuromuscular Blockade for Optimising Surgical Conditions During Spinal Surgery

NCT02778945 | Unknown Phase 4 DMC

• 1 other identifier: ANESTHA-NMB1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 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

Keywords

spinal surgery; sugammadex; deep neuromuscular block; shear wave elastography; neuromuscular monitoring

Outcome Measures

Primary Outcomes (1)

• the operation time

  Primary endpoint: To compare the measurements of the operation time reduction, the operation time should be recorded by institutional electronic medical chart from the incision to the final suture closure of surgical wound. A difference of 10% change of operation time between two groups is considered of clinically meaningful difference.

  Intraoperative

Secondary Outcomes (2)

• back muscle stiffness ( 1. Shear Wave Ultrasound Elastography(SWE) )

  Intraoperative

• back muscle stiffness (2.Mechanical Tension Weighing Scale (MTWS) of mechanical dynamometer)

  Intraoperative

Other Outcomes (8)

• post-anesthetic care unit stay

  1 hour after operation

• transfer rate to intensive care unit

  1 hour after operation

• post-op pain score

  30minutes, 6hours, 12hours, 48hours after operation

Study Arms (2)

Group D (Deep NMB group)

EXPERIMENTAL

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 0.9 mg/kg

Group I (Intermediate NMB group)

ACTIVE COMPARATOR

Use NMB as conventional clinical usage 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

Drug: Rocuronium 0.6 mg/kg

Interventions

Rocuronium 0.9 mg/kg DRUG

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.

Group D (Deep NMB group)

Rocuronium 0.6 mg/kg DRUG

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

Group I (Intermediate NMB group)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients had to be scheduled by the surgeons for an elective spinal surgery required correction of 1 to 3 segment level of spine under general anesthesia.
• Patients with ASA-classification (the American Society of Anesthesiologists) physical status classed as I to II aged 19 years old and over will be enrolled.

You may not qualify if:

• expected a difficult airway
• known neuromuscular disease
• known allergy or hypersensitivity to one of the drugs used in this study
• intake of any medication that might interact with muscle relaxants.
• Female subjects will be excluded if they were either pregnant, of childbearing potential, not using a mechanical method of birth control, or if they were breast-feeding.
• subjects who are unable to understand or successfully administer a patient controlled analgesia (PCA) device,
• subjects who are declined to participate during the protocol

Sponsors & Collaborators

• The Catholic University of Korea: lead

Study Sites (1)

Yeouido St. Mary's Hospital

Seoul, 07345, South Korea

RECRUITING

Related Publications (18)

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MeSH Terms

Conditions

Muscle Weakness

Interventions

Rocuronium

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Jin Young Chon, M.D., Ph.D.

  Department of Anesthesiology and pain medicine, Yeouido St. Mary's Hospital

  STUDY CHAIR

Central Study Contacts

Jin Young Chon, M.D., Ph.D.

CONTACT

82-2-3779-1268; anestha@catholic.ac.kr

Ho Sik Moon, M.D., Ph.D.

CONTACT

82-2-3779-1900; mhsjshcat@catholic.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Anesthesiology and Pain Medicine, The Catholic University of Korea, College of Medicine,

Study Record Dates

• First Submitted: April 22, 2016
• First Posted: May 20, 2016
• Study Start: September 1, 2016
• Primary Completion: March 28, 2019
• Study Completion: May 1, 2019
• Last Updated: April 1, 2019

Record last verified: 2019-03

Locations

KR (1)