Clinical trial NCT04716439: Effect of TIVA With Magnesium Sulfate on IONM in Patients Undergoing Spine Surgery
Official title: Effect of Total Intravenous Anesthesia (TIVA) With Magnesium Sulfate on Intra-Operative Neuromonitoring (IONM) in Patients Undergoing Spine Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spine Surgery
Lead sponsor: King Khalid University Hospital
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adult ASA 1OR 2

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)

Eligibility criteria: Inclusion Criteria:

* Adult Patients Undergoing Spine Surgery

Exclusion Criteria:

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

Primary outcomes:
measure: IONM Reading
timeFrame: 1- baseline 2-during surgery 3-immediately after surgery
Secondary outcomes:
measure: Blood Pressure
timeFrame: 1- baseline 2-during surgery 3-immediately after surgery 4- every one hour postoperative till 24 hours
measure: Heart Rate
timeFrame: 1- baseline 2-during surgery 3-immediately after surgery 4- every one hour postoperative till 24 hours
measure: Morphine Consumption
timeFrame: Over 24 hours postoperative
measure: Pain Score
timeFrame: Over 24 hours postoperative
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Anesthesia Department, Faculty of Medicine, King Khalid University Hospital, King Saud University
Study officials:
affiliation: Assistant Professor and Consultant, Anesthesia Department, Faculty of Medicine, KKUH, KSU, Riyadh, Saudi Arabia
name: ESSAM M MANAA, MD
role: PRINCIPAL_INVESTIGATOR
References: