Spine Surgery
Conditions
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)
Interventions
PROCEDURESpine Surgery
spine decompression and fixation
Sponsors
King Khalid University Hospital
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Adult Patients Undergoing Spine Surgery
Exclusion criteria
1. Renal Impairment 2. Liver Cell failure 3. Heart Block
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Morphine Consumption | Over 24 hours postoperative | Total morphine consumed over 24 hours in mg |
| Blood Pressure | 1- baseline 2-during surgery 3-immediately after surgery 4- every one hour postoperative till 24 hours | Systolic, Diastolic and Mean (mmHg) |
| Heart Rate | 1- baseline 2-during surgery 3-immediately after surgery 4- every one hour postoperative till 24 hours | beats/min |
| Pain Score | Over 24 hours postoperative | 11 Visual Analogue Scale (VAS) with 10 is the worst and 0 is the least |
Countries
Saudi Arabia
Contacts
Primary ContactESSAM M MANAA, MD
Outcome results
None listed