Neuromuscular Blockade for Optimising Surgical Conditions During Spinal Surgery

Muscle Weakness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02778945
• Other study ID #: ANESTHA-NMB1
• Status: Recruiting
• Phase: Phase 4
• Start date: September 1, 2016
• Est. completion date: May 1, 2019

Study information

• Verified date: March 2019
• Source: The Catholic University of Korea
• Contact: Jin Young Chon, M.D., Ph.D.
• Phone: 82-2-3779-1268
• Email: anestha[@]catholic.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 1, 2019
• Est. primary completion date: March 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Muscle Weakness
• Musculoskeletal Diseases
• Neuromuscular Block
• Orthopedic Disorder of Spine
• Paresis
• Spinal Diseases

Intervention

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.
• 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

Locations

Country	Name	City	State
Korea, Republic of	Yeouido St. Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (18)

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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. — View Citation

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. — View Citation

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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. — View Citation

de Paula Simola RÁ, 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. — View Citation

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Fryer G, Morris T, Gibbons P. Paraspinal muscles and intervertebral dysfunction: part two. J Manipulative Physiol Ther. 2004 Jun;27(5):348-57. Review. — View Citation

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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. — View Citation

Lacourpaille L, Hug F, Guével A, Péréon 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. — View Citation

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. — View Citation

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. Review. — View Citation

Oliva-Pascual-Vaca Á, Heredia-Rizo AM, Barbosa-Romero A, Oliva-Pascual-Vaca J, Rodríguez-Blanco C, Tejero-García 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. — View Citation

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* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	post-anesthetic care unit stay	time duration during post-anesthetic care unit stay	1 hour after operation
Other	transfer rate to intensive care unit		1 hour after operation
Other	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
Other	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
Other	total hospital cost	calculated in KRW	4 weeks after operation
Other	surgical condition	evaluate surgical conditions using a Visual Analogue Scale(VAS score) asked to surgeon and anesthesiologist, respectively.	Intraoperative
Other	intraoperative ventilation parameters (1. lung compliance)	lung compliance is measured by anesthetic machine ( GE Avance)	Intraoperative
Other	intraoperative ventilation parameters (2. peak airway pressure)	peak pressure is measured by anesthetic machine ( GE Avance)	Intraoperative
Primary	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
Secondary	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.	Intraoperative
Secondary	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