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Comparison Of Deep Versus Moderate Neuromuscular Blockade on Intra-Operative Blood Loss During Spinal Surgery

A

Assiut University

Status and phase

Unknown
Early Phase 1

Conditions

Spine Fracture

Treatments

Drug: Rocuronium
Device: nerve stimulator

Study type

Interventional

Funder types

Other

Identifiers

NCT05294926
spine surgery anesthesia

Details and patient eligibility

About

Reduction of intra-operative blood loss

Full 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.

Enrollment

88 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts 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).

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

88 participants in 2 patient groups

deep neuromuscular blockade
Active Comparator group
Treatment:
Device: nerve stimulator
Drug: Rocuronium
moderate neuromuscular blockade
Active Comparator group
Treatment:
Device: nerve stimulator
Drug: Rocuronium

Trial contacts and locations

0

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Central trial contact

Mohamed Refaat Shaaban Abd El-aal, Dr

Data sourced from clinicaltrials.gov

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