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

NCT05294926 | Unknown Early Phase 1

• 1 other identifier: spine surgery anesthesia
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

Brief Summary

Reduction of intra-operative blood loss

Conditions

Spine Fracture

Keywords

spine; surgery; anesthesia; blood loss

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline

Secondary Outcomes (1)

• surgeon's satisfaction with the operating conditions

  Baseline

Study Arms (2)

deep neuromuscular blockade

ACTIVE COMPARATOR

Drug: Rocuronium; Device: nerve stimulator

moderate neuromuscular blockade

ACTIVE COMPARATOR

Drug: Rocuronium; Device: nerve stimulator

Interventions

Rocuronium DRUG

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

deep neuromuscular blockade; moderate neuromuscular blockade

nerve stimulator DEVICE

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.

deep neuromuscular blockade; moderate neuromuscular blockade

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Assiut University: lead

Related Publications (9)

• 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.

  PMID: 2063971 BACKGROUND

• 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.

  PMID: 8882241 BACKGROUND

• 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.

  PMID: 1763593 BACKGROUND

• 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.

  PMID: 18211991 BACKGROUND

• 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.

  PMID: 24809482 BACKGROUND

• 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.

  PMID: 24240315 BACKGROUND

• 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.

  PMID: 25684372 BACKGROUND

• 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.

  PMID: 26945393 BACKGROUND

• 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.

  PMID: 31860601 BACKGROUND

MeSH Terms

Conditions

Spinal Fractures; Hemorrhage

Interventions

Rocuronium

Condition Hierarchy (Ancestors)

Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Mohamed Abdel-Moneim Bakr Eid, Professor

  1.2

  STUDY CHAIR

• Ola Mahmoud Wahba Gnedy, Professor

  1.1, 2.2, 3.4

  STUDY DIRECTOR

• Shimaa Abbas Hassan, Dr

  1.3, 2.1

  STUDY DIRECTOR

Central Study Contacts

Mohamed Refaat Shaaban Abd El-aal, Dr

CONTACT

+201140541916; mohamed.20134278@med.au.edu.eg

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized double blinded clinical trial

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: March 24, 2022
• Study Start: April 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: March 30, 2023
• Last Updated: March 24, 2022

Record last verified: 2022-03