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

Spine Surgery Clinical Trial

Official title: Effect of Total Intravenous Anesthesia (TIVA) With Magnesium Sulfate on Intra-Operative Neuromonitoring (IONM) in Patients Undergoing Spine Surgery

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial 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) ;

Related Conditions & MeSH terms

• Spine Surgery

• NCT number: NCT04716439
• Study type: Observational [Patient Registry]
• Source: King Khalid University Hospital
• Contact: ESSAM M MANAA, MD
• Phone: +966509870124
• Email: e_manaa@yahoo.com
• Status: Not yet recruiting
• Start date: February 2021
• Completion date: October 2021