Neuromuscular Blockade for Optimising Surgical Conditions During Spinal Surgery

March 28, 2019 updated by: Chon Jin Young, The Catholic University of Korea

Deep Versus Moderate Neuromuscular Blockade for Optimising Surgical Conditions Include Patient Benefits During Spinal Surgery: A Randomized Controlled Double Blinded Clinical Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

All patients will be randomly assigned to two groups after IRB (institutional review board) approval, receiving either deep neuromuscular blockade (''Deep NMB'') or intermediate neuromuscular block (''Control NMB''). Enrolled patients will be given a number in sequence of their enrollment and received a treatment code using a randomization schedule.

The team taking care of patient perioperatively will be blinded regarding the study; this included the surgeons (This study use two different responsible surgeon attendings) and their team, the anesthesia care team in the operating room, in the PACU and the pain physician responsible for postoperative pain management (same as the protocols of the departmental and hospital clinical process).

An additional unblinded anesthesiologist involved in the study management will present from patients' arrival in the operation room to the patients' discharge from the PACU. The unblinded study anesthesiologist takes care of the patients' anesthesia induction, calibration and documentation of the neuromuscular monitoring and the management of the neuromuscular blockade.

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.

Secondary endpoints:

By using Mechanical Tension Weighing Scale (MTWS) of mechanical dynamometer and also Shear Wave Ultrasound Elastography(SWE), values are taken as followings.

  1. Shear Wave Ultrasound Elastography(SWE):

    SWE score value will be collected 3 times as followings. First, After enrolled, the obtained informed consent for this clinical study and screening, SWE score measure will be taken prior to surgery as a basal value from the patient.

    Second, After Induction and patient positioning, measure the targeted back muscle stiffness by using ultrasonography of SWE.

    Third, SWE score measure finally after the stich out before the discharge.

  2. Mechanical Tension Weighing Scale(MTWS) of mechanical dynamometer:

After surgical incision, measure the targeted back muscle stiffness by using MTWS. It will be compared between the study groups.

Other check points:

To compare the safety and benefits of deep neuromuscular block over intermediate conventional NMB with corresponding sugammadex reversal.

(Other check points might be changed before the clinical trial initiation circumstantially)

The other check point variables will be collected for investigating to compare the safety and benefits which are divided into patients, surgeons and anesthesiologists' ones by collecting the variety of clinical parameters.

  1. For patients intraoperative radiation amount, operation duration, anesthesia duration, post-anesthetic care unit(PACU) stay, transfer rate to SICU for post-op. care, post-operative respiratory complication rate, post-op pain score include patient controlled analgesia(PCA), post-op nausea and vomiting(PONV), and total hospital costs.
  2. For surgeons unintended movements during surgery, compromised operating field by tense surrounding muscles, post-operative complications in regard to operation field, and evaluate surgical conditions using a Visual Analogue Scale(VAS score) which will be correlated with muscle stiffness measure by weighing scale and SWE.
  3. For anesthesiologists Anesthetic time, intraoperative ventilation parameters of patients, intraoperative vital sign monitor values, and evaluate surgical conditions using a Visual Analogue Scale(VAS score) which will be correlated with muscle stiffness measure by weighing scale and SWE.

All clinical parameters will be collected within 48 hours after surgery except the total hospital costs of the patients.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 07345
        • Recruiting
        • Yeouido St. Mary's Hospital
        • Contact:
        • Principal Investigator:
          • Jin Young Chon, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group D (Deep NMB group)
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
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.
Active Comparator: Group I (Intermediate NMB group)
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the operation time
Time Frame: Intraoperative

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
back muscle stiffness ( 1. Shear Wave Ultrasound Elastography(SWE) )
Time Frame: Intraoperative

1. Shear Wave Ultrasound Elastography(SWE): SWE score value will be collected 3 times as followings. First, After enrolled, the obtained informed consent for this clinical study and screening, SWE score measure will be taken prior to surgery as a basal value from the patient.

Second, After Induction and patient positioning, measure the targeted back muscle stiffness by using ultrasonography of SWE.

Third, SWE score measure finally after the stich out before the discharge.
Intraoperative
back muscle stiffness (2.Mechanical Tension Weighing Scale (MTWS) of mechanical dynamometer)
Time Frame: Intraoperative
2. Mechanical Tension Weighing Scale(MTWS) of mechanical dynamometer: After surgical incision, measure the targeted back muscle stiffness by using MTWS. It will be compared between the study groups.
Intraoperative

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
post-anesthetic care unit stay
Time Frame: 1 hour after operation
time duration during post-anesthetic care unit stay
1 hour after operation
transfer rate to intensive care unit
Time Frame: 1 hour after operation
1 hour after operation
post-op pain score
Time Frame: 30minutes, 6hours, 12hours, 48hours after operation
post operative pain is measured when 30 minutes, 6 hours, 12 hours, 24 hours, 48 hours postoperatively using visual analogue scale.
30minutes, 6hours, 12hours, 48hours after operation
post-op nausea and vomiting(PONV)
Time Frame: 30minutes, 6hours, 12hours, 48hours after operation
post operative nausea and vomiting is measured when 30 minutes, 6 hours, 12 hours, 24 hours, 48 hours postoperatively using visual analogue scale.
30minutes, 6hours, 12hours, 48hours after operation
total hospital cost
Time Frame: 4 weeks after operation
calculated in KRW
4 weeks after operation
surgical condition
Time Frame: Intraoperative
evaluate surgical conditions using a Visual Analogue Scale(VAS score) asked to surgeon and anesthesiologist, respectively.
Intraoperative
intraoperative ventilation parameters (1. lung compliance)
Time Frame: Intraoperative
lung compliance is measured by anesthetic machine ( GE Avance)
Intraoperative
intraoperative ventilation parameters (2. peak airway pressure)
Time Frame: Intraoperative
peak pressure is measured by anesthetic machine ( GE Avance)
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Catholic University of Korea

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

March 28, 2019

Study Completion (Anticipated)

May 1, 2019

Study Registration Dates

First Submitted

April 22, 2016

First Submitted That Met QC Criteria

May 18, 2016

First Posted (Estimate)

May 20, 2016

Study Record Updates

Last Update Posted (Actual)

April 1, 2019

Last Update Submitted That Met QC Criteria

March 28, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANESTHA-NMB1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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