Effect of Magnesium Sulfate Bolus on Intraoperative Neuromonitoring

NCT04938765 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 5210244
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Magnesium Sulfate(MgSo4) is increasingly being used as part of the multimodal pain regimen in the perioperative period. The intraoperative neurophysiological monitoring (IONM) is utilized in complex spine and cranial surgeries to assess the functional integrity of the neural pathways. The effect of Magnesium sulfate on IONM has not been studied. This is a prospective, double blind, randomized placebo controlled trial to study the effect of Magnesium sulfate bolus on the amplitude and latency of somatosensory(SSEPs) and motor evoked potentials(MEPs) in patients undergoing surgery requiring IONM.

Conditions

Magnesium Sulfate; Intraoperative Neurophysiological Monitoring

Keywords

multimodal analgesia

Outcome Measures

Primary Outcomes (1)

• Change in the amplitude of SSEPs.

  Baseline SSEP recording is done before the administration of MgSo4 or placebo and will be compared with the SSEPs measured at 0,10 and 30 minutes following the end of the bolus dose of MgSO4 or normal saline. Any change in the amplitude will be analyzed. For SSEPs, 50% reduction in amplitude will be considered as significant change.

  Up to 30 minutes after the end of bolus dose of MgSO4 or Normal saline.

Secondary Outcomes (2)

• Change in the latency of SSEP compared to baseline.

  Up to 30 minutes after the end of bolus dose of MgSO4 or Normal saline.

• Change in the amplitude of MEPs.

  Up to 30 minutes after the end of bolus dose of MgSO4 or Normal saline.

Study Arms (2)

Magnesium sulfate arm

EXPERIMENTAL

MgSo4 diluted to 20% will be administered at 40 mg/kg dosed to ideal body weight over 10min to the study arm followed by 10mg/kg/hr infusion.

Drug: Magnesium sulfate

Normal Saline

PLACEBO COMPARATOR

20 ml of normal saline bolus will be administered to the control group over 10 mins.

Drug: Normal Saline

Interventions

Magnesium sulfate DRUG

Effect of 40mg/kg Magnesium sulfate bolus dosed to ideal body weight on intraoperative neuromonitoring

Magnesium sulfate arm

Normal Saline DRUG

20 ml of normal saline bolus will be administered to the control group over 10 mins.

Normal Saline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 to 80 years
• Belonging to American Society of Anesthesiologists physical status (ASA) I, II
• Undergoing elective spine or cranial surgery where intraoperative neuromonitoring including short latency somatosensory evoked potentials (SSEP or SEP) and transcranial electrical muscle motor evoked potentials recording from muscles (TceMEP or TcMEP or mMEP or MEP) is planned.

You may not qualify if:

• Magnesium use within the last 2 days, either intravenous or oral supplements.
• Patients with known electrolyte imbalances (Sodium \<135 or \>145 mmol/L OR Potassium \< 3.5 or \> 5.0 mmol/L, Magnesium \>1.2 mmol/L.
• Severe cardiac or cardiac conduction disorders.
• Severe pulmonary disease.
• Patients with significant neuromuscular disorders or preexisting motor or sensory deficits other than focal upper limb neuropathy or focal cervical radiculopathy or mild cervical myelopathy.
• Severe Renal disease - serum creatinine of \> 2 mg/dl.
• Pregnant or breastfeeding patients.
• Unable to obtain adequate baseline SSEPs and MEPs.

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma linda University Medical Center

Loma Linda, California, 92354, United States

RECRUITING

Related Publications (19)

• Albrecht E, Kirkham KR, Liu SS, Brull R. Peri-operative intravenous administration of magnesium sulphate and postoperative pain: a meta-analysis. Anaesthesia. 2013 Jan;68(1):79-90. doi: 10.1111/j.1365-2044.2012.07335.x. Epub 2012 Nov 1.

  PMID: 23121612 BACKGROUND

• De Oliveira GS Jr, Castro-Alves LJ, Khan JH, McCarthy RJ. Perioperative systemic magnesium to minimize postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2013 Jul;119(1):178-90. doi: 10.1097/ALN.0b013e318297630d.

  PMID: 23669270 BACKGROUND

• Guo BL, Lin Y, Hu W, Zhen CX, Bao-Cheng Z, Wu HH, Kaye AD, Duan JH, Qu Y. Effects of Systemic Magnesium on Post-operative Analgesia: Is the Current Evidence Strong Enough? Pain Physician. 2015 Sep-Oct;18(5):405-18.

  PMID: 26431120 BACKGROUND

• Arumugam, S. , S. M. Lau, C. and Chamberlain, R. (2016) Perioperative Adjunct Magnesium Decreases Postoperative Opioid Requirements-A Meta-Analysis. International Journal of Clinical Medicine, 7, 297-308. doi: 10.4236/ijcm.2016.75032.

  BACKGROUND

• Dehkordy ME, Tavanaei R, Younesi E, Khorasanizade S, Farsani HA, Oraee-Yazdani S. Effects of perioperative magnesium sulfate infusion on intraoperative blood loss and postoperative analgesia in patients undergoing posterior lumbar spinal fusion surgery: A randomized controlled trial. Clin Neurol Neurosurg. 2020 Sep;196:105983. doi: 10.1016/j.clineuro.2020.105983. Epub 2020 Jun 2.

  PMID: 32521394 BACKGROUND

• Kizilcik N, Koner O. Magnesium Sulfate Reduced Opioid Consumption in Obese Patients Undergoing Sleeve Gastrectomy: a Prospective, Randomized Clinical Trial. Obes Surg. 2018 Sep;28(9):2783-2788. doi: 10.1007/s11695-018-3243-7.

  PMID: 29754384 BACKGROUND

• Shin HJ, Kim EY, Na HS, Kim TK, Kim MH, Do SH. Magnesium sulphate attenuates acute postoperative pain and increased pain intensity after surgical injury in staged bilateral total knee arthroplasty: a randomized, double-blinded, placebo-controlled trial. Br J Anaesth. 2016 Oct;117(4):497-503. doi: 10.1093/bja/aew227. Epub 2016 Oct 17.

  PMID: 28077538 BACKGROUND

• Ballesteros-Flores CG, Garrido-Aguirre E, Carrillo-Esper R, et al. Hypomagnesemia in the perioperative period. Current concepts. Rev Mex Anest. 2013;36(2):114-118.

  BACKGROUND

• Whittaker JD, Downes F, Becker H, Garnham A, Wall M. Influence of Perioperative Serum Magnesium for Cardiac and Noncardiac Morbidity and Mortality Following Emergency Peripheral Vascular Surgery. J Cardiothorac Vasc Anesth. 2019 Feb;33(2):474-479. doi: 10.1053/j.jvca.2018.05.042. Epub 2018 May 28.

  PMID: 30045811 BACKGROUND

• Herroeder S, Schonherr ME, De Hert SG, Hollmann MW. Magnesium--essentials for anesthesiologists. Anesthesiology. 2011 Apr;114(4):971-93. doi: 10.1097/ALN.0b013e318210483d.

  PMID: 21364460 BACKGROUND

• Hicks MA, Tyagi A. Magnesium Sulfate. [Updated 2020 May 8]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2021 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK554553/

  BACKGROUND

• Okusanya BO, Oladapo OT, Long Q, Lumbiganon P, Carroli G, Qureshi Z, Duley L, Souza JP, Gulmezoglu AM. Clinical pharmacokinetic properties of magnesium sulphate in women with pre-eclampsia and eclampsia. BJOG. 2016 Feb;123(3):356-66. doi: 10.1111/1471-0528.13753. Epub 2015 Nov 24.

  PMID: 26599617 BACKGROUND

• Yanni DS, Ulkatan S, Deletis V, Barrenechea IJ, Sen C, Perin NI. Utility of neurophysiological monitoring using dorsal column mapping in intramedullary spinal cord surgery. J Neurosurg Spine. 2010 Jun;12(6):623-8. doi: 10.3171/2010.1.SPINE09112.

  PMID: 20515347 BACKGROUND

• Huang ZF, Chen L, Yang JF, Deng YL, Sui WY, Yang JL. Multimodality Intraoperative Neuromonitoring in Severe Thoracic Deformity Posterior Vertebral Column Resection Correction. World Neurosurg. 2019 Jul;127:e416-e426. doi: 10.1016/j.wneu.2019.03.140. Epub 2019 Apr 11.

  PMID: 30981802 BACKGROUND

• Minahan RE. Intraoperative neuromonitoring. Neurologist. 2002 Jul;8(4):209-26. doi: 10.1097/00127893-200207000-00001.

  PMID: 12803681 BACKGROUND

• Cofano F, Zenga F, Mammi M, Altieri R, Marengo N, Ajello M, Pacca P, Melcarne A, Junemann C, Ducati A, Garbossa D. Intraoperative neurophysiological monitoring during spinal surgery: technical review in open and minimally invasive approaches. Neurosurg Rev. 2019 Jun;42(2):297-307. doi: 10.1007/s10143-017-0939-4. Epub 2018 Jan 8.

  PMID: 29313181 BACKGROUND

• Sloan TB, Heyer EJ. Anesthesia for intraoperative neurophysiologic monitoring of the spinal cord. J Clin Neurophysiol. 2002 Oct;19(5):430-43. doi: 10.1097/00004691-200210000-00006.

  PMID: 12477988 BACKGROUND

• Nunes RR, Bersot CDA, Garritano JG. Intraoperative neurophysiological monitoring in neuroanesthesia. Curr Opin Anaesthesiol. 2018 Oct;31(5):532-538. doi: 10.1097/ACO.0000000000000645.

  PMID: 30020157 BACKGROUND

• Santonocito C, Noto A, Crimi C, Sanfilippo F. Remifentanil-induced postoperative hyperalgesia: current perspectives on mechanisms and therapeutic strategies. Local Reg Anesth. 2018 Apr 9;11:15-23. doi: 10.2147/LRA.S143618. eCollection 2018.

  PMID: 29670398 BACKGROUND

MeSH Terms

Interventions

Magnesium Sulfate; Saline Solution

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Rashmi Vandse, MD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rashmi Vandse, MD

CONTACT

9095584000; rvandse@llu.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Study drug or the placebo will be administered after inducing general anesthesia hence patient will be masked. study drug or the placebo will be administered by the anesthesia team and this will not be disclosed to the neuro monitoring team who sits far away from the anesthesia workstation.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective double blind randomized clinical trial

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: June 24, 2021
• Study Start: March 18, 2022
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)