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

NCT ID: NCT04716439

Last Updated: 2021-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-28

Study Completion Date

2021-10-31

Brief Summary

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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

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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)

Conditions

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Spine Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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magnesium sulfate effect on IONM reading in spine surgery

one group receives magnesium other do not

Spine Surgery

Intervention Type PROCEDURE

spine decompression and fixation

Interventions

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Spine Surgery

spine decompression and fixation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adult Patients Undergoing Spine Surgery

Exclusion Criteria

1. Renal Impairment
2. Liver Cell failure
3. Heart Block
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Khalid University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Essam M. Manaa (MD)

Assistant Professor & Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ESSAM M MANAA, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor and Consultant, Anesthesia Department, Faculty of Medicine, KKUH, KSU, Riyadh, Saudi Arabia

Locations

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Anesthesia Department, Faculty of Medicine, King Khalid University Hospital, King Saud University

Riyadh, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

Central Contacts

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ESSAM M MANAA, MD

Role: CONTACT

+966509870124

Other Identifiers

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E-20-4965

Identifier Type: -

Identifier Source: org_study_id

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