Spine SurgeryNCT04716439
Effect of TIVA With Magnesium Sulfate on IONM in Patients Undergoing Spine Surgery
An observational study of Spine Surgery, run by King Khalid University Hospital at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Spine Surgery
- What is being tested?
- Spine Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Feb 2021to Oct 2021
- How long will I take part?
- 8 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adult ASA 1OR 2
Who may be able to join
- Adult Patients Undergoing Spine Surgery
Who cannot join
- Renal Impairment
- Liver Cell failure
- Heart Block
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Anesthesia Department, Faculty of Medicine, King Khalid University Hospital, King Saud University
Riyadh
About this study
Official title: Effect of Total Intravenous Anesthesia (TIVA) With Magnesium Sulfate on Intra-Operative Neuromonitoring (IONM) in Patients Undergoing Spine Surgery
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.
Read the detailed description
Objectives:
- Decrease anesthetic consumption
- Decrease use of muscle relaxants
- Decrease analgesic consumption
- 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:
- IONM
- train-of-four (TOF)
- bispectral index (BIS)
Measurements:
- IO Anesthetic Consumption
- IO Hemodynamics
- somatosensory evoked potential (SSEP), motor evoked potential (MEP), TOF, BIS Readings
- PO visual analogue scale (VAS) (24hours)
- PO Morphine Consumption (24hours)
- Conditions
- Spine Surgery
- Being tested
- Spine Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spine SurgeryProcedure or surgery
spine decompression and fixation
| Study group | Role | What they receive |
|---|---|---|
| magnesium sulfate effect on IONM reading in spine surgery | one group receives magnesium other do not Receives: Procedure: Spine Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
IONM Reading
Reading the effect on the intraoperative neuromonitoring either motor or sensory evoked potential
Measured: 1- baseline 2-during surgery 3-immediately after surgery
Secondary outcomes (4)
Blood Pressure
Systolic, Diastolic and Mean (mmHg)
Measured: 1- baseline 2-during surgery 3-immediately after surgery 4- every one hour postoperative till 24 hours
Heart Rate
beats/min
Measured: 1- baseline 2-during surgery 3-immediately after surgery 4- every one hour postoperative till 24 hours
Morphine Consumption
Total morphine consumed over 24 hours in mg
Measured: Over 24 hours postoperative
Pain Score
11 Visual Analogue Scale (VAS) with 10 is the worst and 0 is the least
Measured: Over 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study startFeb 2021 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
- Target duration
- 8 Months
Sponsor and investigators
- Lead sponsor
- King Khalid University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Essam M. Manaa (MD), King Khalid University Hospital
- Investigators
- ESSAM M MANAA, MD, Principal investigator, Assistant Professor and Consultant, Anesthesia Department, Faculty of Medicine, KKUH, KSU, Riyadh, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04716439
- Sponsor's protocol ID
- E-20-4965
- Status last verified
- Jan 2021
- First submitted
- 11 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Total Intravenous Anesthesia (TIVA) With Magnesium Sulfate on Intra-Operative Neuromonitoring (IONM) in Patients Undergoing Spine Surgery
- ClinicalTrials.gov ID
- NCT04716439
- Acronym / sponsor ID
- E-20-4965
- Conditions
- Spine Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- King Khalid University HospitalUniversity, hospital or other
- Study start
- Feb 2021 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Decrease anesthetic consumption
- Decrease use of muscle relaxants
- Decrease analgesic consumption
- 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:
- IONM
- train-of-four (TOF)
- bispectral index (BIS)
Measurements:
- IO Anesthetic Consumption
- IO Hemodynamics
- somatosensory evoked potential (SSEP), motor evoked potential (MEP), TOF, BIS Readings
- PO visual analogue scale (VAS) (24hours)
- PO Morphine Consumption (24hours)
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 8 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| magnesium sulfate effect on IONM reading in spine surgery | – | Procedure: Spine Surgeryone group receives magnesium other do not |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adult ASA 1OR 2
Key inclusion criteria (1 listed)
- Adult Patients Undergoing Spine Surgery
Key exclusion criteria (3 listed)
- Renal Impairment
- Liver Cell failure
- Heart Block
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spine Surgeryspine decompression and fixation | Procedure or surgery | magnesium sulfate effect on IONM reading in spine surgery |
Primary outcome
IONM Reading
Time frame: 1- baseline 2-during surgery 3-immediately after surgery
Reading the effect on the intraoperative neuromonitoring either motor or sensory evoked potential
4 secondary outcomes
Blood Pressure
Time frame: 1- baseline 2-during surgery 3-immediately after surgery 4- every one hour postoperative till 24 hours
Heart Rate
Time frame: 1- baseline 2-during surgery 3-immediately after surgery 4- every one hour postoperative till 24 hours
Morphine Consumption
Time frame: Over 24 hours postoperative
Pain Score
Time frame: Over 24 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for Spine Surgery
Not yet recruiting
Adding Different Doses of Dexmedetomidine to Bupivecaine in Erector Spinae Plane Block
Postoperative Pain in Lumbar Spine Surgery
Recruiting
Lumbar Paravertebral Block vs Erector Spinae Plane Block in Elderly Patients Undergoing Lumbar Spine Surgery
Spine Disease
Recruiting
FIBERGRAFT Aeridyan Posterolateral Fusion Study
Degenerative Spine Disease
RecruitingPhase 4
Perioperative Rectal Methadone in Spine Surgery
Spinal Surgery, Post-operative Care
Not yet recruiting
MALMOS Technique for Selected Subaxial Cervical Spine Fractures
Cervical Spine Fractures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ESSAM M MANAA, MD principal investigator
Assistant Professor and Consultant, Anesthesia Department, Faculty of Medicine, KKUH, KSU, Riyadh, Saudi Arabia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spine Surgery, run by King Khalid University Hospital at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ESSAM M MANAA, MD (+966509870124, e_manaa@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IONM Reading (time frame: 1- baseline 2-during surgery 3-immediately after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.