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Effect of TIVA With Magnesium Sulfate on IONM in Patients Undergoing Spine Surgery

K

King Khalid University Hospital

Status

Unknown

Conditions

Spine Surgery

Treatments

Procedure: Spine Surgery

Study type

Observational

Funder types

Other

Identifiers

NCT04716439
E-20-4965

Details and patient eligibility

About

Anesthesia for neurosurgery requires balancing deep and effective anesthesia as well as postoperative analgesia versus the risks of delayed recovery and postoperative respiratory depression. This randomized placebo-controlled, double-blind study was designed to evaluate the effect of magnesium sulfate on the total anesthetic and analgesic consumption using the clinical parameters in addition to the effect on IONM reading.

Full description

Objectives:

  1. Decrease anesthetic consumption
  2. Decrease use of muscle relaxants
  3. Decrease analgesic consumption
  4. Excellent recovery

Patients & Methods:

  • 2 groups (total 50) Randomized Controlled Double Blind (RCDB) Study
  • Propofol + remifentanil + saline (Control = C group)
  • Propofol + remifentanil + Mgso4 (Magnesium = M group)
  • Adult Spine decompression and fixation After getting the Institutional Review Board (IRB) approval, This randomized controlled double blind study includes 2 groups of patients (each group 25) will be enrolled in the study. All patients undergo spine decompression and fixation surgery

Induction:

All patients in the study will receive iv fentanyl 2 mic/kg + propofol 2mg/kg and endotracheal intubation will be facilitated with rocuronium 0.60 mg/ kg. Then anesthesia will be maintained using total intravenous anesthesia with propofol (6-9 mg/kg/hr) + remifentanil (0.03-0.05 mic / kg/ min) Group 1 (C group) : Receive 10 mg/kg /hr 0.9% Normal Saline Group 2 (M group) : Receive 10 mg/kg/hr Magnesium Sulfate

Monitoring:

  1. IONM
  2. train-of-four (TOF)
  3. bispectral index (BIS)

Measurements:

  1. IO Anesthetic Consumption
  2. IO Hemodynamics
  3. somatosensory evoked potential (SSEP), motor evoked potential (MEP), TOF, BIS Readings
  4. PO visual analogue scale (VAS) (24hours)
  5. PO Morphine Consumption (24hours)

Enrollment

50 estimated patients

Sex

All

Ages

30 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult Patients Undergoing Spine Surgery

Exclusion criteria

  1. Renal Impairment
  2. Liver Cell failure
  3. Heart Block

Trial design

50 participants in 1 patient group

magnesium sulfate effect on IONM reading in spine surgery
Description:
one group receives magnesium other do not
Treatment:
Procedure: Spine Surgery

Trial contacts and locations

1

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Central trial contact

ESSAM M MANAA, MD

Data sourced from clinicaltrials.gov

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