Cerebral Desaturation EventsPhase 3mg/dex/rSO2NCT06848595
Mg Sulfate Versus Dexmedetomidine on Cerebral Oxygen Saturation
A Phase 3 study testing spine surgery, Magnesium sulfate and Dexmedetomidine in people with Cerebral Desaturation Events and Spine Surgeries, run by Tanta University.
Trial summary
This study is to evaluate the effects of dexmedetomidine and magnesium sulfate on cerebral oxygen saturation in patients undergoing spine surgeries as adjuvant to general anesthesia guided by cerebral oximetry. The main aims to are Incidence of cerebral desaturation events and duration of cerebral desaturation events. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Cerebral Desaturation Events, Spine Surgeries
- What is being tested?
- spine surgery, Magnesium sulfate and Dexmedetomidine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 23 Feb 2025to 31 Jan 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age from 21 to 60 years old.
- either gender.
- American Society of Anesthesiologists (ASA) physical status I and II.
Who cannot join
- Patient refusal to participate in research.
- History of preoperative neuromuscular disease.
- Patients with preexisting cerebral pathology (such as previous episodes of cerebral ischemia or stroke).
- History of psychiatric illness.
- History of orthostatic hypotension, myocardial infarction, uncontrolled hypertension or documented carotid stenosis.
- Coagulopathy disorder.
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- Patients receiving magnesium supplementation.
- Chronic use of opioids.
- Current treatment with a β-blocker or calcium channel blocker.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Dexmedetomidine Versus Magnesium Sulfate on Cerebral Oxygen Saturation During Spine Surgery: a Prospective Randomized Controlled Study
This study is to evaluate the effects of dexmedetomidine and magnesium sulfate on cerebral oxygen saturation in patients undergoing spine surgeries as adjuvant to general anesthesia guided by cerebral oximetry. The main aims to are Incidence of cerebral desaturation events and duration of cerebral desaturation events.
- Conditions
- Cerebral Desaturation Events, Spine Surgeries
- Being tested
- spine surgery, Magnesium sulfate, Dexmedetomidine, Normal Saline (0.9% NaCl)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spine surgeryProcedure or surgery
spine surgery in prone position
Magnesium sulfateDrug
Patients will receive loading dose of 40 mg/kg of magnesium sulfate diluted in 50 ml of 0.9% saline IVI will be given in 10 min before anesthesia induction then continuous infusion of 10 mg/kg/hour during the surgery.
DexmedetomidineDrug
Patients will receive loading dose of 1 mcg/kg dexmedetomidine diluted in 50 ml of saline 0.9% IVI will be given in 10 min before anesthesia induction then continuous infusion of 0.5 mcg/kg/hour during the surgery.
Normal Saline (0.9% NaCl)Drug
Patients will receive the same volume of normal saline.
| Study group | Role | What they receive |
|---|---|---|
| MgSO4 | Active comparator | loading dose of 40 mg/kg of magnesium sulfate diluted in 50 ml of 0.9% saline IVI will be given in 10 min before anesthesia induction then continuous infusion of 10 mg/kg/hour during the surgery. Receives: Procedure: spine surgery; Drug: Magnesium sulfate |
| dex. | Active comparator | Patients will receive loading dose of 1 mcg/kg dexmedetomidine diluted in 50 ml of saline 0.9% IVI will be given in 10 min before anesthesia induction then continuous infusion of 0.5 mcg/kg/hour during the surgery. Receives: Procedure: spine surgery; Drug: Dexmedetomidine |
| control | Placebo comparator | Patients will receive the same volume of normal saline. Receives: Procedure: spine surgery; Drug: Normal Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of cerebral desaturation events.
Measured: intraoperative
Secondary outcomes (3)
Duration of cerebral desaturation events
Measured: intraoperative
change in heart rate in beats
Measured: intraoperative
change in blood pressure in mmHg
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start23 Feb 2025 (estimated)
- Primary completion20 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Desaturation EventsStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Elsayed, Tanta University
- Investigators
- Ahmed Said Elgebaly, professor, Study director, Tanta UniversityShimaa Farouk Abdelkader, professor, Study director, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848595
- Sponsor's protocol ID
- 36265MD317/11/24
- Acronym
- mg/dex/rSO2
- Status last verified
- Feb 2025
- First submitted
- 21 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dexmedetomidine Versus Magnesium Sulfate on Cerebral Oxygen Saturation During Spine Surgery: a Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06848595
- Acronym / sponsor ID
- mg/dex/rSO2 / 36265MD317/11/24
- Conditions
- Cerebral Desaturation Events, Spine Surgeries
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 23 Feb 2025 (estimated)
- Primary completion
- 20 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 27 Feb 2025 (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.
This study is to evaluate the effects of dexmedetomidine and magnesium sulfate on cerebral oxygen saturation in patients undergoing spine surgeries as adjuvant to general anesthesia guided by cerebral oximetry. The main aims to are Incidence of cerebral desaturation events and duration of cerebral desaturation events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MgSO4 | Active comparator | Procedure: spine surgery, Drug: Magnesium sulfateloading dose of 40 mg/kg of magnesium sulfate diluted in 50 ml of 0.9% saline IVI will be given in 10 min before anesthesia induction then continuous infusion of 10 mg/kg/hour during the surgery. |
| dex. | Active comparator | Procedure: spine surgery, Drug: DexmedetomidinePatients will receive loading dose of 1 mcg/kg dexmedetomidine diluted in 50 ml of saline 0.9% IVI will be given in 10 min before anesthesia induction then continuous infusion of 0.5 mcg/kg/hour during the surgery. |
| control | Placebo comparator | Procedure: spine surgery, Drug: Normal Saline (0.9% NaCl)Patients will receive the same volume of normal saline. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age from 21 to 60 years old.
- either gender.
- American Society of Anesthesiologists (ASA) physical status I and II.
Key exclusion criteria (9 listed)
- Patient refusal to participate in research.
- History of preoperative neuromuscular disease.
- Patients with preexisting cerebral pathology (such as previous episodes of cerebral ischemia or stroke).
- History of psychiatric illness.
- History of orthostatic hypotension, myocardial infarction, uncontrolled hypertension or documented carotid stenosis.
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 surgery in prone position | Procedure or surgery | MgSO4, control, dex. |
| Magnesium sulfatePatients will receive loading dose of 40 mg/kg of magnesium sulfate diluted in 50 ml of 0.9% saline IVI will be given in 10 min before anesthesia induction then continuous infusion of 10 mg/kg/hour during the surgery. | Drug | MgSO4 |
| DexmedetomidinePatients will receive loading dose of 1 mcg/kg dexmedetomidine diluted in 50 ml of saline 0.9% IVI will be given in 10 min before anesthesia induction then continuous infusion of 0.5 mcg/kg/hour during the surgery. | Drug | dex. |
| Normal Saline (0.9% NaCl)Patients will receive the same volume of normal saline. | Drug | control |
Primary outcome
Incidence of cerebral desaturation events.
Time frame: intraoperative
3 secondary outcomes
Duration of cerebral desaturation events
Time frame: intraoperative
change in heart rate in beats
Time frame: intraoperative
change in blood pressure in mmHg
Time frame: Intraoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Individual participant dataSharing planned: No
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.
Ahmed Said Elgebaly, professor study director
Tanta University
Shimaa Farouk Abdelkader, professor study director
Tanta University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing spine surgery, Magnesium sulfate and Dexmedetomidine in people with Cerebral Desaturation Events and Spine Surgeries, run by Tanta University.
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 3 inclusion and 9 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: opening soon, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ibrahim Elsayed Elnefiawy, assisstant lectuerer (00201001515007, aborazan171@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of cerebral desaturation events. (time frame: intraoperative). 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 27 Feb 2025.