Effect of Neuromuscular Blockade on Operating Conditions and Overall Satisfaction During Spinal Surgery
NCT ID: NCT02724111
Last Updated: 2017-10-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
90 participants
INTERVENTIONAL
2016-05-15
2017-02-16
Brief Summary
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Detailed Description
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* Inclusion criteria: American Society of Anesthesiologists (ASA) physical status I-II adults, aged 18-75 years, scheduled for elective spinal surgery (cervical or lumbar surgeries which have lesions no more than 3 spinal levels and not monitored by MEP) of duration \>1 hour and prone position under total intravenous anesthesia (TIVA).
* Exclusion criteria: Pregnancy, the receipt of medication known to interfere with neuromuscular blockade, diseases affecting neuromuscular transmission, and the history of hypersensitivity on rocuronium or sugammadex. The patients who will have hemodynamic instability, mean blood pressure increase or fall of \> 30% from baseline (lasting for more than 5min), and blood loss \> 1 L during surgery, and MEP monitored surgeries.
* Outcome Measures
* Primary outcome: Mean value of peak inspiratory pressure recorded every 15 minutes.
* Secondary outcomes:
1. The number of body movements (including cough or any diaphragm movement).
2. The degree of bleeding of each patient scaled by surgeons (Intraoperative scale for assessment of operating condition of surgical field: 0 - No bleeding, 1 - Slight bleeding - no suctioning of blood required, 2 - Slight bleeding - occasional suctioning required but not threatened the operative field, 3 - Slight-bleeding - frequent suctioning of blood was required that threatens the operative field a few seconds after suctioning, 4 - Moderate bleeding - frequent suctioning of blood was required which threatens the operative field directly after suctioning, 5 - Sever bleeding - continuous suctioning of blood was required which severely threatened the operative field make the surgery not possible).
3. The muscle tone of each patient scaled by surgeons (1: muscle tone is good, suitable for surgery; 2: muscle tone is moderate, but do not affect the operation; 3: muscle tone is hard, making the operation difficult.).
* Three time-points of assessment of the muscle tone: ① At the placement of back muscle retractor for opening the operating site after the skin and subcutaneous incision, ② At the screw insertion through the pedicle of spine during surgery, ③ At the other period (overall muscle tone).
4. Mean value of pressure of back muscle retractor placed in the operating site (recorded every 15 minutes): measured by the pressure probe placed between the retractor and the back muscle.
5. Overall satisfaction of surgeons for the surgical condition will be assessed by the surgeons who perform surgery using numerical rating scale (NRS; 1-10) after surgery.
6. Recovery profiles including eye opening time, extubation time and sedation score (the Observer's Assessment of Alertness/ Sedation (OAA/S) score; awake, 5 to unresponsive, 1) every 10 min for 1 hour at postanesthesia care unit (PACU).
7. Postoperative adverse events
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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deep neuromuscular blockade
This arm will be given sufficient dose of rocuronium. In this Arm group, rocuronium will be administered to maintain deep neuromuscular blockade \[NMB\] (train-of-four \[TOF\] count 0, post-tetanic count \[PTC\] of 1-2 twitches) until the end of surgery and the reversal of NMB will be performed by sugammadex 4 mg/kg at the end of surgery'.
sufficient dose of rocuronium
restricted neuromuscular blockade
This arm will not be given sufficient dose of rocuronium. In this Arm group, sugammadex will be administered according to the prescribing indications (4 mg/kg for deep neuromuscular blockade \[NMB\] state or 2 mg/kg for moderate NMB or less) to reverse the NMB 10 min after position change (sugammadex 10 min after position change \[a prone position\]). Thereafter, muscle relaxants will not be injected any more throughout the surgery except the following situations: If the patients show any body movement during surgery or if surgeons express any complaint about muscle tone (the muscle tone: grade 3), rescue rocuronium 5 mg will be administered and the number of body movements and rescue rocuronium administration (dose) will be recorded.
sugammadex 10 min after position change
Interventions
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sufficient dose of rocuronium
sugammadex 10 min after position change
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Present medication known to interfere with neuromuscular blockade
* Diseases affecting neuromuscular transmission
* History of hypersensitivity on rocuronium or sugammadex
* Emergent spinal surgery
* Spinal surgeries which have lesions more than 3 spinal levels
* Spinal surgeries which have duration less than 1 hour
* Spinal surgeries which are not performed under prone position
* Spinal surgeries which are not performed under total intravenous anesthesia (TIVA).
* Patients who will have hemodynamic instability (mean blood pressure increase or fall of \> 30% from baseline lasting for more than 5 min) during surgery
* Patients who will have blood loss \> 1 L during surgery
* MEP monitored spinal surgeries
18 Years
75 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Korea University Guro Hospital
OTHER
Responsible Party
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Byung Gun Lim
Associate Professor
Principal Investigators
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Byung Gun Lim, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Korea University Guro Hospital
Locations
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Korea University Guro Hospital
Seoul, , South Korea
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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KUGH15297-002
Identifier Type: -
Identifier Source: org_study_id