Clinical trial NCT05294926: 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
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Spine Fracture
Keywords: spine
surgery
anesthesia
blood loss
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized double blinded clinical trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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).

Primary outcomes:
measure: Volume of surgical bleeding.
timeFrame: Baseline
Secondary outcomes:
measure: surgeon's satisfaction with the operating conditions
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: 1.2
name: Mohamed Abdel-Moneim Bakr Eid, Professor
role: STUDY_CHAIR
affiliation: 1.1, 2.2, 3.4
name: Ola Mahmoud Wahba Gnedy, Professor
role: STUDY_DIRECTOR
affiliation: 1.3, 2.1
name: Shimaa Abbas Hassan, Dr
role: STUDY_DIRECTOR
References:
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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.
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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.
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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.
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.
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.