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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04716439
• Other study ID #: E-20-4965
• Status: Not yet recruiting
• Start date: February 2021
• Est. completion date: October 2021

Study information

• Verified date: January 2021
• Source: King Khalid University Hospital
• Contact: ESSAM M MANAA, MD
• Phone: +966509870124
• Email: e_manaa[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: October 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

Inclusion Criteria:

• Adult Patients Undergoing Spine Surgery

Exclusion Criteria:

1. Renal Impairment

2. Liver Cell failure

3. Heart Block

Related Conditions & MeSH terms

• Spine Surgery

Intervention

Procedure:
• Spine Surgery
spine decompression and fixation

Locations

Country	Name	City	State
Saudi Arabia	Anesthesia Department, Faculty of Medicine, King Khalid University Hospital, King Saud University	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
King Khalid University Hospital

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

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