Comparison Of Deep Versus Moderate Neuromuscular Blockade on Intra-Operative Blood Loss During Spinal Surgery
Primary Purpose
Spine Fracture
Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Rocuronium
nerve stimulator
Sponsored by
About this trial
This is an interventional health services research trial for Spine Fracture focused on measuring spine, surgery, anesthesia, blood loss
Eligibility Criteria
Inclusion Criteria:
- Age 18- 65 years.
- American Society of Anesthesiologists physical status classification (ASA) I - III
- Patients scheduled for posterior lumbar interbody fusion (2-level or 3-level).
Exclusion Criteria:
- Urgent or emergency case or re-operation.
- 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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
deep neuromuscular blockade
moderate neuromuscular blockade
Arm Description
Outcomes
Primary Outcome Measures
Volume of surgical bleeding.
Volume of surgical bleeding will be recorded before surgical field lavage, and again at the end of surgery, by measuring the total volume of blood collected in the suction bottle minus the lavage fluid volume used for wound irrigation.
Secondary Outcome Measures
surgeon's satisfaction with the operating conditions
The score for the surgeon's satisfaction (lowest, 1; highest, 5) with the surgical conditions will be assessed at the end of surgery. Extremely poor (Score 1) indicated that the surgeon is unable to work because of an inability to obtain a visible field due to inadequate muscle relaxation; poor (Score 2) indicated that there is a visible field, but the surgeon is severely hampered by inadequate muscle relaxation; acceptable (Score 3) indicated that there is a wide visible field and acceptable muscle relaxation; good (Score 4) indicated a wide working field with adequate muscle relaxation; excellent (Score 5) indicated a wide visible working field without any muscle rigidity.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05294926
Brief Title
Comparison Of Deep Versus Moderate Neuromuscular Blockade on Intra-Operative Blood Loss During Spinal Surgery
Official Title
Comparison Of Deep Versus Moderate Neuromuscular Blockade on Intra-Operative Blood Loss During Spinal Surgery, Randomized Double Blinded Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2022 (Anticipated)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
March 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Reduction of intra-operative blood loss
Detailed Description
Spine surgery is usually performed using a posterior approach with the patient in the prone position, but on the other hand this position causes venous engorgement in the back and increases bleeding with the risk of interruption of surgery and increases the need for blood transfusion. The prone position also produces undesirable haemodynamic changes resulting from compression of large vessels and decreased venous return to the heart.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spine Fracture
Keywords
spine, surgery, anesthesia, blood loss
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
randomized double blinded clinical trial
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
deep neuromuscular blockade
Arm Type
Active Comparator
Arm Title
moderate neuromuscular blockade
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Rocuronium
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
nerve stimulator
Intervention Description
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.
Primary Outcome Measure Information:
Title
Volume of surgical bleeding.
Description
Volume of surgical bleeding will be recorded before surgical field lavage, and again at the end of surgery, by measuring the total volume of blood collected in the suction bottle minus the lavage fluid volume used for wound irrigation.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
surgeon's satisfaction with the operating conditions
Description
The score for the surgeon's satisfaction (lowest, 1; highest, 5) with the surgical conditions will be assessed at the end of surgery. Extremely poor (Score 1) indicated that the surgeon is unable to work because of an inability to obtain a visible field due to inadequate muscle relaxation; poor (Score 2) indicated that there is a visible field, but the surgeon is severely hampered by inadequate muscle relaxation; acceptable (Score 3) indicated that there is a wide visible field and acceptable muscle relaxation; good (Score 4) indicated a wide working field with adequate muscle relaxation; excellent (Score 5) indicated a wide visible working field without any muscle rigidity.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18- 65 years.
American Society of Anesthesiologists physical status classification (ASA) I - III
Patients scheduled for posterior lumbar interbody fusion (2-level or 3-level).
Exclusion Criteria:
Urgent or emergency case or re-operation.
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Refaat Shaaban Abd El-aal, Dr
Phone
+201140541916
Email
mohamed.20134278@med.au.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Abdel-Moneim Bakr Eid, Professor
Organizational Affiliation
1.2
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ola Mahmoud Wahba Gnedy, Professor
Organizational Affiliation
1.1, 2.2, 3.4
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Shimaa Abbas Hassan, Dr
Organizational Affiliation
1.3, 2.1
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
2063971
Citation
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.
Results Reference
background
PubMed Identifier
8882241
Citation
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.
Results Reference
background
PubMed Identifier
1763593
Citation
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.
Results Reference
background
PubMed Identifier
18211991
Citation
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.
Results Reference
background
PubMed Identifier
24809482
Citation
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.
Results Reference
background
PubMed Identifier
24240315
Citation
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.
Results Reference
background
PubMed Identifier
25684372
Citation
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.
Results Reference
background
PubMed Identifier
26945393
Citation
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.
Results Reference
background
PubMed Identifier
31860601
Citation
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.
Results Reference
background
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Comparison Of Deep Versus Moderate Neuromuscular Blockade on Intra-Operative Blood Loss During Spinal Surgery
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