Neuromuscular Blockade for Optimising Surgical Conditions During Spinal Surgery
Primary Purpose
Neuromuscular Block, Orthopedic Disorder of Spine, Muscle Weakness
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rocuronium 0.9 mg/kg
Rocuronium 0.6 mg/kg
Sponsored by
About this trial
This is an interventional diagnostic trial for Neuromuscular Block focused on measuring spinal surgery, sugammadex, deep neuromuscular block, shear wave elastography, neuromuscular monitoring
Eligibility Criteria
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
Sites / Locations
- Yeouido St. Mary's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group D (Deep NMB group)
Group I (Intermediate NMB group)
Arm Description
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.
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
back muscle stiffness ( 1. Shear Wave Ultrasound Elastography(SWE) )
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.
back muscle stiffness (2.Mechanical Tension Weighing Scale (MTWS) of mechanical dynamometer)
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.
Full Information
NCT ID
NCT02778945
First Posted
April 22, 2016
Last Updated
March 28, 2019
Sponsor
The Catholic University of Korea
1. Study Identification
Unique Protocol Identification Number
NCT02778945
Brief Title
Neuromuscular Blockade for Optimising Surgical Conditions During Spinal Surgery
Official Title
Deep Versus Moderate Neuromuscular Blockade for Optimising Surgical Conditions Include Patient Benefits During Spinal Surgery: A Randomized Controlled Double Blinded Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
March 28, 2019 (Actual)
Study Completion Date
May 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
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.
For anesthesiologists Intraoperative ventilation parameters of patients, and evaluate surgical conditions using a Visual Analogue Scale(VAS score) in anesthesiologist's side.
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.
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.
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.
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.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromuscular Block, Orthopedic Disorder of Spine, Muscle Weakness
Keywords
spinal surgery, sugammadex, deep neuromuscular block, shear wave elastography, neuromuscular monitoring
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group D (Deep NMB group)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group I (Intermediate NMB group)
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Rocuronium 0.9 mg/kg
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Rocuronium 0.6 mg/kg
Intervention Description
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
Primary Outcome Measure Information:
Title
the operation time
Description
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.
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
back muscle stiffness ( 1. Shear Wave Ultrasound Elastography(SWE) )
Description
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.
Time Frame
Intraoperative
Title
back muscle stiffness (2.Mechanical Tension Weighing Scale (MTWS) of mechanical dynamometer)
Description
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.
Time Frame
Intraoperative
Other Pre-specified Outcome Measures:
Title
post-anesthetic care unit stay
Description
time duration during post-anesthetic care unit stay
Time Frame
1 hour after operation
Title
transfer rate to intensive care unit
Time Frame
1 hour after operation
Title
post-op pain score
Description
post operative pain is measured when 30 minutes, 6 hours, 12 hours, 24 hours, 48 hours postoperatively using visual analogue scale.
Time Frame
30minutes, 6hours, 12hours, 48hours after operation
Title
post-op nausea and vomiting(PONV)
Description
post operative nausea and vomiting is measured when 30 minutes, 6 hours, 12 hours, 24 hours, 48 hours postoperatively using visual analogue scale.
Time Frame
30minutes, 6hours, 12hours, 48hours after operation
Title
total hospital cost
Description
calculated in KRW
Time Frame
4 weeks after operation
Title
surgical condition
Description
evaluate surgical conditions using a Visual Analogue Scale(VAS score) asked to surgeon and anesthesiologist, respectively.
Time Frame
Intraoperative
Title
intraoperative ventilation parameters (1. lung compliance)
Description
lung compliance is measured by anesthetic machine ( GE Avance)
Time Frame
Intraoperative
Title
intraoperative ventilation parameters (2. peak airway pressure)
Description
peak pressure is measured by anesthetic machine ( GE Avance)
Time Frame
Intraoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin Young Chon, M.D., Ph.D.
Phone
82-2-3779-1268
Email
anestha@catholic.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Ho Sik Moon, M.D., Ph.D.
Phone
82-2-3779-1900
Email
mhsjshcat@catholic.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Young Chon, M.D., Ph.D.
Organizational Affiliation
Department of Anesthesiology and pain medicine, Yeouido St. Mary's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Yeouido St. Mary's Hospital
City
Seoul
ZIP/Postal Code
07345
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Young Chon, M.D., Ph.D.
Phone
82-2-3779-1268
Email
anestha@catholic.ac.kr
First Name & Middle Initial & Last Name & Degree
Jin Young Chon, M.D., Ph.D.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Neuromuscular Blockade for Optimising Surgical Conditions During Spinal Surgery
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