Comparison Of Deep Versus Moderate Neuromuscular Blockade on Intra-Operative Blood Loss During Spinal Surgery
NCT ID: NCT05294926
Last Updated: 2022-03-24
Study Results
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Basic Information
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UNKNOWN
EARLY_PHASE1
88 participants
INTERVENTIONAL
2022-04-01
2023-03-30
Brief Summary
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Detailed Description
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Deep neuromuscular blockade has been shown to improve surgical conditions compared with moderate neuromuscular blockade in various surgical procedures specially different laparoscopic procedures to optimize surgical field conditions. In spine surgery, although many other factors such as the body habitus of the patient and the surgical equipment are important, an improvement in surgical field conditions can be achieved through reducing muscle tension in the back, and also reducing intra-abdominal and thoracic pressure. This goal may be attainable by using deep neuromuscular blockade. Better operating conditions offer the surgeon easier access to the surgical field with less damage. However, the effect of deep neuromuscular blockade on surgical bleeding in spinal surgery in the prone position has been yet under evaluation.
The investigators hypothesise that deep, compared with moderate, neuromuscular blockade would cause less surgical bleeding in spinal surgery in the prone position. The investigators aim to evaluate the effects and superiority of deep neuromuscular blockade on surgical bleeding in patients undergoing posterior lumbar interbody fusion surgery in the prone position.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
TRIPLE
Study Groups
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deep neuromuscular blockade
Rocuronium
After applying standard monitoring of pulse oximetry, ECG, noninvasive blood pressure, general anesthesia will be induced with fentanyl 1 µg/kg and propofol 2-3 mg/kg and Rocuronium 0.6 mg/kg will be administered for muscle relaxation after loss of consciousness, under the guidance of neuromuscular blockade monitoring. Tracheal intubation will be performed at a train-of-four count of 0. After that end-tidal carbon dioxide and temperature will be continuously monitored during the procedure. Mechanical ventilation will be instituted with o2:air of 4 L/min, tidal volume of 6-8 ml/kg and respiratory rate appropriate to achieving end-tidal carbon dioxide of 30-35 mmHg. no positive end-expiratory pressure; and inspiratory/expiratory ratio 1: 2. The patient's position will then be changed from supine to prone. Ephedrine 4 mg (if mean arterial pressure \< 60 mmHg and heart rate \< 40 bpm), or atropine 0.5 to 1.0 mg (if heart rate \< 40 bpm) are used to prevent hypotension or bradycardia
nerve stimulator
Neuromuscular blockade monitoring will be established and continuously monitored after induction using the Train Of Four (TOF) at the adductor pollicis muscle on the opposite hand and wrist to radial artery cannulation. Two surface electrocardiography electrodes will be placed on cleaned skin overlying the ulnar nerve, with one electrode positioned on the ulnar side of the flexor carpi radialis tendon and the other positioned 3cm proximal to the first. The transducer is then positioned with the flat side against the thumb. Supramaximal stimuli will be applied after autonomic calibration of acceleromyograph after an initial tetanic stimulus. After confirming a train-of-four ratio of 95 to 105%, neuromuscular blockade monitoring will start. The train-of-four mode of supramaximal stimulation (0.2 ms duration, frequency 2 Hz, two s duration) will be applied at 15 s intervals, which last until the end of anaesthesia.
moderate neuromuscular blockade
Rocuronium
After applying standard monitoring of pulse oximetry, ECG, noninvasive blood pressure, general anesthesia will be induced with fentanyl 1 µg/kg and propofol 2-3 mg/kg and Rocuronium 0.6 mg/kg will be administered for muscle relaxation after loss of consciousness, under the guidance of neuromuscular blockade monitoring. Tracheal intubation will be performed at a train-of-four count of 0. After that end-tidal carbon dioxide and temperature will be continuously monitored during the procedure. Mechanical ventilation will be instituted with o2:air of 4 L/min, tidal volume of 6-8 ml/kg and respiratory rate appropriate to achieving end-tidal carbon dioxide of 30-35 mmHg. no positive end-expiratory pressure; and inspiratory/expiratory ratio 1: 2. The patient's position will then be changed from supine to prone. Ephedrine 4 mg (if mean arterial pressure \< 60 mmHg and heart rate \< 40 bpm), or atropine 0.5 to 1.0 mg (if heart rate \< 40 bpm) are used to prevent hypotension or bradycardia
nerve stimulator
Neuromuscular blockade monitoring will be established and continuously monitored after induction using the Train Of Four (TOF) at the adductor pollicis muscle on the opposite hand and wrist to radial artery cannulation. Two surface electrocardiography electrodes will be placed on cleaned skin overlying the ulnar nerve, with one electrode positioned on the ulnar side of the flexor carpi radialis tendon and the other positioned 3cm proximal to the first. The transducer is then positioned with the flat side against the thumb. Supramaximal stimuli will be applied after autonomic calibration of acceleromyograph after an initial tetanic stimulus. After confirming a train-of-four ratio of 95 to 105%, neuromuscular blockade monitoring will start. The train-of-four mode of supramaximal stimulation (0.2 ms duration, frequency 2 Hz, two s duration) will be applied at 15 s intervals, which last until the end of anaesthesia.
Interventions
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Rocuronium
After applying standard monitoring of pulse oximetry, ECG, noninvasive blood pressure, general anesthesia will be induced with fentanyl 1 µg/kg and propofol 2-3 mg/kg and Rocuronium 0.6 mg/kg will be administered for muscle relaxation after loss of consciousness, under the guidance of neuromuscular blockade monitoring. Tracheal intubation will be performed at a train-of-four count of 0. After that end-tidal carbon dioxide and temperature will be continuously monitored during the procedure. Mechanical ventilation will be instituted with o2:air of 4 L/min, tidal volume of 6-8 ml/kg and respiratory rate appropriate to achieving end-tidal carbon dioxide of 30-35 mmHg. no positive end-expiratory pressure; and inspiratory/expiratory ratio 1: 2. The patient's position will then be changed from supine to prone. Ephedrine 4 mg (if mean arterial pressure \< 60 mmHg and heart rate \< 40 bpm), or atropine 0.5 to 1.0 mg (if heart rate \< 40 bpm) are used to prevent hypotension or bradycardia
nerve stimulator
Neuromuscular blockade monitoring will be established and continuously monitored after induction using the Train Of Four (TOF) at the adductor pollicis muscle on the opposite hand and wrist to radial artery cannulation. Two surface electrocardiography electrodes will be placed on cleaned skin overlying the ulnar nerve, with one electrode positioned on the ulnar side of the flexor carpi radialis tendon and the other positioned 3cm proximal to the first. The transducer is then positioned with the flat side against the thumb. Supramaximal stimuli will be applied after autonomic calibration of acceleromyograph after an initial tetanic stimulus. After confirming a train-of-four ratio of 95 to 105%, neuromuscular blockade monitoring will start. The train-of-four mode of supramaximal stimulation (0.2 ms duration, frequency 2 Hz, two s duration) will be applied at 15 s intervals, which last until the end of anaesthesia.
Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologists physical status classification (ASA) I - III
* Patients scheduled for posterior lumbar interbody fusion (2-level or 3-level).
Exclusion Criteria
* History of pre-operative anticoagulant medication or an indication for peri-operative anticoagulant medication.
* ASA classification more than III.
* Age less than 16 years.
* Reduced left and right ventricular function (ejection fraction \<40%).
* Previous respiratory disease or a diagnosed neuromuscular disorder.
* Pre-operative dysrhythmia.
* Allergy to neuromuscular blocking agents.
* Family history of malignant hyperthermia.
* Decreased renal function (serum creatinine level more than twice the normal range, urine output \<0.5 ml kg/h, glomerular filtration ratio \<60 ml/ h).
18 Years
65 Years
ALL
Yes
Sponsors
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Assiut University
OTHER
Responsible Party
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Mohamed Refaat Shaaban Abd El-aal
Principal Investigator
Principal Investigators
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Mohamed Abdel-Moneim Bakr Eid, Professor
Role: STUDY_CHAIR
1.2
Ola Mahmoud Wahba Gnedy, Professor
Role: STUDY_DIRECTOR
1.1, 2.2, 3.4
Shimaa Abbas Hassan, Dr
Role: STUDY_DIRECTOR
1.3, 2.1
Central Contacts
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References
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Hatada T, Kusunoki M, Sakiyama T, Sakanoue Y, Yamamura T, Okutani R, Kono K, Ishida H, Utsunomiya J. Hemodynamics in the prone jackknife position during surgery. Am J Surg. 1991 Jul;162(1):55-8. doi: 10.1016/0002-9610(91)90202-o.
Wadsworth R, Anderton JM, Vohra A. The effect of four different surgical prone positions on cardiovascular parameters in healthy volunteers. Anaesthesia. 1996 Sep;51(9):819-22. doi: 10.1111/j.1365-2044.1996.tb12608.x.
Yokoyama M, Ueda W, Hirakawa M, Yamamoto H. Hemodynamic effect of the prone position during anesthesia. Acta Anaesthesiol Scand. 1991 Nov;35(8):741-4. doi: 10.1111/j.1399-6576.1991.tb03382.x.
Edgcombe H, Carter K, Yarrow S. Anaesthesia in the prone position. Br J Anaesth. 2008 Feb;100(2):165-83. doi: 10.1093/bja/aem380.
Dubois PE, Putz L, Jamart J, Marotta ML, Gourdin M, Donnez O. Deep neuromuscular block improves surgical conditions during laparoscopic hysterectomy: a randomised controlled trial. Eur J Anaesthesiol. 2014 Aug;31(8):430-6. doi: 10.1097/EJA.0000000000000094.
Martini CH, Boon M, Bevers RF, Aarts LP, Dahan A. Evaluation of surgical conditions during laparoscopic surgery in patients with moderate vs deep neuromuscular block. Br J Anaesth. 2014 Mar;112(3):498-505. doi: 10.1093/bja/aet377. Epub 2013 Nov 15.
Van Wijk RM, Watts RW, Ledowski T, Trochsler M, Moran JL, Arenas GW. Deep neuromuscular block reduces intra-abdominal pressure requirements during laparoscopic cholecystectomy: a prospective observational study. Acta Anaesthesiol Scand. 2015 Apr;59(4):434-40. doi: 10.1111/aas.12491. Epub 2015 Feb 13.
Kim MH, Lee KY, Lee KY, Min BS, Yoo YC. Maintaining Optimal Surgical Conditions With Low Insufflation Pressures is Possible With Deep Neuromuscular Blockade During Laparoscopic Colorectal Surgery: A Prospective, Randomized, Double-Blind, Parallel-Group Clinical Trial. Medicine (Baltimore). 2016 Mar;95(9):e2920. doi: 10.1097/MD.0000000000002920.
Kang WS, Oh CS, Rhee KY, Kang MH, Kim TH, Lee SH, Kim SH. Deep neuromuscular blockade during spinal surgery reduces intra-operative blood loss: A randomised clinical trial. Eur J Anaesthesiol. 2020 Mar;37(3):187-195. doi: 10.1097/EJA.0000000000001135.
Other Identifiers
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spine surgery anesthesia
Identifier Type: -
Identifier Source: org_study_id
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