Neuromuscular BlockPhase 4NCT02778945
Neuromuscular Blockade for Optimising Surgical Conditions During Spinal Surgery
A Phase 4 study testing Rocuronium 0.9 mg/kg and Rocuronium 0.6 mg/kg in people with Neuromuscular Block and Orthopedic Disorder of Spine, run by The Catholic University of Korea at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Neuromuscular Block, Orthopedic Disorder of Spine, Muscle Weakness
- What is being tested?
- Rocuronium 0.9 mg/kg and Rocuronium 0.6 mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2016to 1 May 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yeouido St. Mary's Hospital
Seoul, 07345
Jin Young Chon, M.D., Ph.D., 82-2-3779-1268, anestha@catholic.ac.kr
Jin Young Chon, M.D., Ph.D.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Rocuronium 0.9 mg/kg, Rocuronium 0.6 mg/kg
- Keywords
- spinal surgery, sugammadex, deep neuromuscular block, shear wave elastography, neuromuscular monitoring
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocuronium 0.9 mg/kgDrug
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.
Rocuronium 0.6 mg/kgDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Rocuronium 0.6 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperative
Secondary outcomes (2)
back muscle stiffness ( 1. Shear Wave Ultrasound Elastography(SWE) )
- 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.
Measured: Intraoperative
back muscle stiffness (2.Mechanical Tension Weighing Scale (MTWS) of mechanical dynamometer)
- 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.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study start1 Sep 2016
- Primary completion28 Mar 2019
- Study completion1 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chon Jin Young, The Catholic University of Korea
- Investigators
- Jin Young Chon, M.D., Ph.D., Study chair, Department of Anesthesiology and pain medicine, Yeouido St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778945
- Sponsor's protocol ID
- ANESTHA-NMB1
- Status last verified
- Mar 2019
- First submitted
- 22 Apr 2016
- Last updated
- 1 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 15195042Brouwer 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.
PubMed 25614151Li 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.
PubMed 23887680Carron 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.
PubMed 25500396Eichel 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.
PubMed 11697394Mergeay 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.
PubMed 26103736Simons 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.
PubMed 9539669Buchmann 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.
PubMed 23689350de 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.
PubMed 25474337van 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.
PubMed 20462598Oliva-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.
PubMed 24928641Hamzat TK. Physical characteristics as predictors of quadriceps muscle isometric strength: a pilot study. Afr J Med Med Sci. 2001 Sep;30(3):179-81.
PubMed 14510124Bercoff 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.
PubMed 15139541Brandenburg 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.
PubMed 25792582Lacourpaille 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.
PubMed 25187068
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Versus Moderate Neuromuscular Blockade for Optimising Surgical Conditions Include Patient Benefits During Spinal Surgery: A Randomized Controlled Double Blinded Clinical Study
- ClinicalTrials.gov ID
- NCT02778945
- Acronym / sponsor ID
- ANESTHA-NMB1
- Keywords
- spinal surgery, sugammadex, deep neuromuscular block, shear wave elastography, neuromuscular monitoring
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 28 Mar 2019 (actual)
- Study completion
- 1 May 2019 (estimated)
- First posted
- 20 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group D (Deep NMB group) | Experimental | Drug: Rocuronium 0.9 mg/kgNeuromuscular 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 | Drug: Rocuronium 0.6 mg/kgUse 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 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rocuronium 0.9 mg/kgNeuromuscular 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 | Group D (Deep NMB group) |
| Rocuronium 0.6 mg/kgNeuromuscular 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 | Group I (Intermediate NMB group) |
Primary outcome
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.
2 secondary outcomes
back muscle stiffness ( 1. Shear Wave Ultrasound Elastography(SWE) )
Time frame: Intraoperative
back muscle stiffness (2.Mechanical Tension Weighing Scale (MTWS) of mechanical dynamometer)
Time frame: Intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2019.
- Background: PubMed 15195042Fryer 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.
- Background: PubMed 25614151Brouwer 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.
- Background: PubMed 23887680Li 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.
- Background: PubMed 25500396Carron 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.
- Background: PubMed 11697394Eichel 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.
- Background: PubMed 26103736Mergeay 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.
- Background: PubMed 9539669Simons 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.
- Background: PubMed 23689350Buchmann 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.
- Background: PubMed 25474337de 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.
- Background: PubMed 20462598van 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.
- Background: PubMed 24928641Oliva-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.
- Background: PubMed 14510124Hamzat TK. Physical characteristics as predictors of quadriceps muscle isometric strength: a pilot study. Afr J Med Med Sci. 2001 Sep;30(3):179-81.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin Young Chon, M.D., Ph.D. study chair
Department of Anesthesiology and pain medicine, Yeouido St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rocuronium 0.9 mg/kg and Rocuronium 0.6 mg/kg in people with Neuromuscular Block and Orthopedic Disorder of Spine, run by The Catholic University of Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin Young Chon, M.D., Ph.D. (82-2-3779-1268, anestha@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the operation time (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02778945, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2019.