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

• Conditions: Spine Surgery

• Registration Number: NCT04716439
• Lead Sponsor: King Khalid University Hospital

Brief 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.

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 Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-01-11
• Study First Submitted QC: 2021-01-15
• Last Update Submitted: 2021-01-19
• Study First Posted: 2021-01-20
• Last Update Posted: 2021-01-22
• Study Start: 2021-02
• Primary Completion: 2021-09
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Adult Patients Undergoing Spine Surgery

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IONM Reading	1- baseline 2-during surgery 3-immediately after surgery	Reading the effect on the intraoperative neuromonitoring either motor or sensory evoked potential

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Anesthesia Department, Faculty of Medicine, King Khalid University Hospital, King Saud University; 🇸🇦 Riyadh, Saudi Arabia