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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Spine Fracture focused on measuring spine, surgery, anesthesia, blood loss

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    December 10, 2021
    Last Updated
    March 22, 2022
    Sponsor
    Assiut University
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    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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