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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.
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.
All clinical parameters will be collected within 48 hours after surgery except the total hospital costs of the patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| post-anesthetic care unit stay | time duration during post-anesthetic care unit stay | 1 hour after operation |
| transfer rate to intensive care unit | 1 hour after operation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Jin Young Chon, M.D., Ph.D. | Department of Anesthesiology and pain medicine, Yeouido St. Mary's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yeouido St. Mary's Hospital | Recruiting | Seoul | 07345 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15195042 | Background | Fryer G, Morris T, Gibbons P. Paraspinal muscles and intervertebral dysfunction: part two. J Manipulative Physiol Ther. 2004 Jun;27(5):348-57. doi: 10.1016/j.jmpt.2004.04.008. | |
| 25614151 | Background | Brouwer PA, Brand R, van den Akker-van Marle ME, Jacobs WC, Schenk B, van den Berg-Huijsmans AA, Koes BW, van Buchem MA, Arts MP, Peul WC. Percutaneous laser disc decompression versus conventional microdiscectomy in sciatica: a randomized controlled trial. Spine J. 2015 May 1;15(5):857-65. doi: 10.1016/j.spinee.2015.01.020. Epub 2015 Jan 20. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 24, 2019 | |
| Reset | Sep 5, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 24, 2019 | Sep 5, 2019 |
| ID | Term |
|---|---|
| D018908 | Muscle Weakness |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
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Not provided
| ID | Term |
|---|---|
| D000077123 | Rocuronium |
| ID | Term |
|---|---|
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| 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 |
|
| Intraoperative |
| 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. | Intraoperative |
| post-op pain score | 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) | 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 | calculated in KRW | 4 weeks after operation |
| surgical condition | evaluate surgical conditions using a Visual Analogue Scale(VAS score) asked to surgeon and anesthesiologist, respectively. | Intraoperative |
| intraoperative ventilation parameters (1. lung compliance) | lung compliance is measured by anesthetic machine ( GE Avance) | Intraoperative |
| intraoperative ventilation parameters (2. peak airway pressure) | peak pressure is measured by anesthetic machine ( GE Avance) | Intraoperative |
| 23887680 | Background | Li YL, Liu YL, Xu CM, Lv XH, Wan ZH. The effects of neuromuscular blockade on operating conditions during general anesthesia for spinal surgery. J Neurosurg Anesthesiol. 2014 Jan;26(1):45-9. doi: 10.1097/ANA.0b013e31829f3805. |
| 25500396 | Background | Carron M. Respiratory benefits of deep neuromuscular block during laparoscopic surgery in a patient with end-stage lung disease. Br J Anaesth. 2015 Jan;114(1):158-9. doi: 10.1093/bja/aeu419. No abstract available. |
| 11697394 | Background | Eichel L, Batzold P, Erturk E. Operator experience and adequate anesthesia improve treatment outcome with third-generation lithotripters. J Endourol. 2001 Sep;15(7):671-3. doi: 10.1089/08927790152596217. |
| 26103736 | Background | Mergeay M, Verster A, Van Aken D, Vercauteren M. Regional versus general anesthesia for spine surgery. A comprehensive review. Acta Anaesthesiol Belg. 2015;66(1):1-9. |
| 9539669 | Background | Simons GD, Mense S. Understanding and measurement of muscle tone as related to clinical muscle pain. Pain. 1998 Mar;75(1):1-17. doi: 10.1016/S0304-3959(97)00102-4. |
| 23689350 | Background | Buchmann J, Neustadt B, Buchmann-Barthel K, Rudolph S, Klauer T, Reis O, Smolenski U, Buchmann H, Wagner KF, Haessler F. Objective measurement of tissue tension in myofascial trigger point areas before and during the administration of anesthesia with complete blocking of neuromuscular transmission. Clin J Pain. 2014 Mar;30(3):191-8. doi: 10.1097/AJP.0b013e3182971866. |
| 25474337 | Background | de Paula Simola RA, Harms N, Raeder C, Kellmann M, Meyer T, Pfeiffer M, Ferrauti A. Assessment of neuromuscular function after different strength training protocols using tensiomyography. J Strength Cond Res. 2015 May;29(5):1339-48. doi: 10.1519/JSC.0000000000000768. |
| 20462598 | Background | van Ramshorst GH, Salih M, Hop WC, van Waes OJ, Kleinrensink GJ, Goossens RH, Lange JF. Noninvasive assessment of intra-abdominal pressure by measurement of abdominal wall tension. J Surg Res. 2011 Nov;171(1):240-4. doi: 10.1016/j.jss.2010.02.007. Epub 2010 Mar 5. |
| 24928641 | Background | Oliva-Pascual-Vaca A, Heredia-Rizo AM, Barbosa-Romero A, Oliva-Pascual-Vaca J, Rodriguez-Blanco C, Tejero-Garcia S. Assessment of paraspinal muscle hardness in subjects with a mild single scoliosis curve: a preliminary myotonometer study. J Manipulative Physiol Ther. 2014 Jun;37(5):326-33. doi: 10.1016/j.jmpt.2014.03.001. |
| 14510124 | Background | Hamzat TK. Physical characteristics as predictors of quadriceps muscle isometric strength: a pilot study. Afr J Med Med Sci. 2001 Sep;30(3):179-81. |
| 15139541 | Background | Bercoff J, Tanter M, Fink M. Supersonic shear imaging: a new technique for soft tissue elasticity mapping. IEEE Trans Ultrason Ferroelectr Freq Control. 2004 Apr;51(4):396-409. doi: 10.1109/tuffc.2004.1295425. |
| 25792582 | Background | Brandenburg JE, Eby SF, Song P, Zhao H, Landry BW, Kingsley-Berg S, Bamlet WR, Chen S, Sieck GC, An KN. Feasibility and reliability of quantifying passive muscle stiffness in young children by using shear wave ultrasound elastography. J Ultrasound Med. 2015 Apr;34(4):663-70. doi: 10.7863/ultra.34.4.663. |
| 25187068 | Background | Lacourpaille L, Hug F, Guevel A, Pereon Y, Magot A, Hogrel JY, Nordez A. Non-invasive assessment of muscle stiffness in patients with Duchenne muscular dystrophy. Muscle Nerve. 2015 Feb;51(2):284-6. doi: 10.1002/mus.24445. Epub 2014 Dec 23. |
| 17635389 | Background | Fuchs-Buder T, Claudius C, Skovgaard LT, Eriksson LI, Mirakhur RK, Viby-Mogensen J; 8th International Neuromuscular Meeting. Good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents II: the Stockholm revision. Acta Anaesthesiol Scand. 2007 Aug;51(7):789-808. doi: 10.1111/j.1399-6576.2007.01352.x. |
| 14652123 | Background | Baykara N, Sahin T, Alpar R, Solak M, Toker K. Evaluation of intense neuromuscular blockade caused by rocuronium using posttetanic count in male and female patients. J Clin Anesth. 2003 Sep;15(6):446-50. doi: 10.1016/s0952-8180(03)00110-7. |
| 16910475 | Background | Takagi S, Ozaki M, Iwasaki H, Hatano Y, Takeda J. [Effects of sevoflurane and propofol on neuromuscular blocking action of Org 9426 (rocuronium bromide) infused continuously in Japanese patients]. Masui. 2006 Aug;55(8):963-70. Japanese. |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D011083 |
| Polycyclic Compounds |