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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Spine Surgery
• Intervention / Treatment: Procedure: Spine Surgery

Detailed 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)

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: ESSAM M MANAA, MD; Phone Number: +966509870124; Email: e_manaa@yahoo.com

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia
    • Anesthesia Department, Faculty of Medicine, King Khalid University Hospital, King Saud University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult ASA 1OR 2

Description

Inclusion Criteria:

• Adult Patients Undergoing Spine Surgery

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
magnesium sulfate effect on IONM reading in spine surgery; one group receives magnesium other do not	Procedure: Spine Surgery; spine decompression and fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IONM Reading	Reading the effect on the intraoperative neuromonitoring either motor or sensory evoked potential	1- baseline 2-during surgery 3-immediately after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure	Systolic, Diastolic and Mean (mmHg)	1- baseline 2-during surgery 3-immediately after surgery 4- every one hour postoperative till 24 hours
Heart Rate	beats/min	1- baseline 2-during surgery 3-immediately after surgery 4- every one hour postoperative till 24 hours
Morphine Consumption	Total morphine consumed over 24 hours in mg	Over 24 hours postoperative
Pain Score	11 Visual Analogue Scale (VAS) with 10 is the worst and 0 is the least	Over 24 hours postoperative

Collaborators and Investigators

• Sponsor: King Khalid University Hospital
• Investigators: Principal Investigator: ESSAM M MANAA, MD, Assistant Professor and Consultant, Anesthesia Department, Faculty of Medicine, KKUH, KSU, Riyadh, Saudi Arabia

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2021
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: January 11, 2021
• First Submitted That Met QC Criteria: January 15, 2021
• First Posted (Actual): January 20, 2021

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 19, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: E-20-4965

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No