Emergence From AnesthesiaPhase 3NCT07443163
Comparison Between Total Intravenous Anesthesia With Magnesium Sulphate Versus Total Intravenous Anesthesia With Dexmedetomidine in Patients Undergoing Lumbar Spine Surgeries
A Phase 3 study testing Dexmedetomidine (Precedex®) and magnesium sulfate in people with Emergence From Anesthesia, run by Cairo University.
Trial summary
Although total intravenous anesthesia (TIVA) provides advantages such as accelerated recuperation and diminished postoperative nausea, it also has constraints, such as the potential for hemodynamic instability and inadequate analgesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Emergence From Anesthesia
- What is being tested?
- Dexmedetomidine (Precedex®) and magnesium sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to Oct 2026
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I, II.
- Scheduled for elective spine surgery up to two levels under general anesthesia
Who cannot join
- History of preoperative neuromuscular disease, hepatic impairment [defined as a known diagnosis of liver cirrhosis, hepatitis with elevated liver enzymes (>2 times upper standard limit), or Child-Pugh score B or C], renal impairment [defined as chronic kidney disease with an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m² or history of dialysis], endocrinal disorders [including uncontrolled diabetes mellitus (HbA1c >8.5%), thyroid dysfunction (untreated hypo/hyperthyroidism), or adrenal insufficiency], hematological disorder [such as anemia (Hb <10 g/dL), coagulopathies (INR >1.5, platelet count <100,000/mm³), or bleeding diathesis] or cardiovascular dysfunction [defined as history of ischemic heart disease, arrhythmias requiring treatment, heart failure (NYHA class II or higher), or uncontrolled hypertension (SBP >160 mmHg or DBP >100 mmHg)].
- Any degree of heart block.
- Known allergy to the study drugs.
- Scoliosis surgery.
- Cervical spine surgeries.
- Surgeries with an anticipated duration of more than 4 hours.
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- Receiving magnesium supplementation.
- Any Preoperative Disturbed consciousness level or cognitive dysfunction.
- Drugs known to have a significant interaction with NMDAs.
- Chronic use of opioids and current treatment with a β-blocker or calcium channel blocker.
About this study
Official title: Comparison Between Total Intravenous Anesthesia With Magnesium Sulphate Versus Total Intravenous Anesthesia With Dexmedetomidine in Patients Undergoing Lumbar Spine Surgeries on Extubation Time: A Randomized Double-Blinded Comparative Study
Although total intravenous anesthesia (TIVA) provides advantages such as accelerated recuperation and diminished postoperative nausea, it also has constraints, such as the potential for hemodynamic instability and inadequate analgesia. TIVA is less suitable for major surgeries, particularly those involving the spine, when used alone, due to these limitations, as they necessitate substantial muscle relaxation and pain management.
A non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor, magnesium sulfate (MgSO4), exhibits antinociceptive properties. The infusion of Magnesium during general anesthesia has been shown to decrease the need for anesthesia and the consumption of postoperative analgesics in numerous clinical studies. MgSO4, when utilized as an adjunct to TIVA, has been demonstrated to decrease the duration of extubation, facilitate earlier emergence from anesthesia, and facilitate intraoperative neurophysiological monitoring (IOM) during spine surgery.
Read more
Dexmedetomidine is a selective α2-adrenoreceptor agonist whose sedative effects are predominantly mediated by its action on α-2 adrenergic receptors in the brain and spinal cord. It delivers efficient sedation without the pronounced respiratory depression that is frequently observed with other sedatives. Dexmedetomidine induces a profound sense of tranquility and alleviates anxiety by selectively targeting specific receptors in the central nervous system, in addition to offering analgesic advantages. Dexmedetomidine has been employed in the surgical intensive care unit to expedite the extubation process. Dexmedetomidine is now being utilized more frequently as an adjuvant for propofol-based TIVA in procedures that necessitateintraoperative neurophysiological monitoring.
There is a paucity of literature comparing TIVA with magnesium sulphate and TIVA with dexmedetomidine in spine surgeries.
- Conditions
- Emergence From Anesthesia
- Being tested
- Dexmedetomidine (Precedex®), magnesium sulfate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine (Precedex®)Drug
Patients will receive a dexmedetomidine loading dose of 1 µg/kg before induction over a period of 15 min and maintenance of 0.5 µg/kg/h throughout the surgery
magnesium sulfateDrug
Patients will receive a magnesium sulfate loading dose of 50 mg/kg before induction over a period of 15 min and maintenance at 15 mg/kg/h throughout the surgery
| Study group | Role | What they receive |
|---|---|---|
| Group D | Active comparator | Not described Receives: Drug: Dexmedetomidine (Precedex®) |
| Group M | Active comparator | Not described Receives: Drug: magnesium sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation time
Time from stoppage of TIVA infusion till extubation of the endotracheal tube
Measured: Up to 2 hours after surgery
Secondary outcomes (5)
Time to the first request for the rescue analgesia
time from the end of surgery to the first dose of morphine administrated
Measured: Up to 24 hours after surgery
Total morphine consumption
Measured: 24 hours postoperative
Ramsay Sedation score
1, anxious or restless or both; 2, cooperative, oriented, relaxed; 3, responding to commands; 4, brisk response to stimulus; 5, sluggish response to stimulus; 6, no response to stimulus
Measured: 24 hours postoperative
Degree of patient satisfaction
Will be assessed on a 5-point Likert scale (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied
Measured: 24 hours postoperative
Incidence of adverse events
Measured: 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 posted2 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence From AnesthesiaStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AbdElKhalik Mahmoud Shaban, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443163
- Sponsor's protocol ID
- MD-313-2025
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Total Intravenous Anesthesia With Magnesium Sulphate Versus Total Intravenous Anesthesia With Dexmedetomidine in Patients Undergoing Lumbar Spine Surgeries on Extubation Time: A Randomized Double-Blinded Comparative Study
- ClinicalTrials.gov ID
- NCT07443163
- Acronym / sponsor ID
- MD-313-2025
- Conditions
- Emergence From Anesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 2 Mar 2026 (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.
Although total intravenous anesthesia (TIVA) provides advantages such as accelerated recuperation and diminished postoperative nausea, it also has constraints, such as the potential for hemodynamic instability and inadequate analgesia. TIVA is less suitable for major surgeries, particularly those involving the spine, when used alone, due to these limitations, as they necessitate substantial muscle relaxation and pain management.
A non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor, magnesium sulfate (MgSO4), exhibits antinociceptive properties. The infusion of Magnesium during general anesthesia has been shown to decrease the need for anesthesia and the consumption of postoperative analgesics in numerous clinical studies. MgSO4, when utilized as an adjunct to TIVA, has been demonstrated to decrease the duration of extubation, facilitate earlier emergence from anesthesia, and facilitate intraoperative neurophysiological monitoring (IOM) during spine surgery.
Dexmedetomidine is a selective α2-adrenoreceptor agonist whose sedative effects are predominantly mediated by its action on α-2 adrenergic receptors in the brain and spinal cord. It delivers efficient sedation without the pronounced respiratory depression that is frequently observed with other sedatives. Dexmedetomidine induces a profound sense of tranquility and alleviates anxiety by selectively targeting specific receptors in the central nervous system, in addition to offering analgesic advantages. Dexmedetomidine has been employed in the surgical intensive care unit to expedite the extubation process. Dexmedetomidine is now being utilized more frequently as an adjuvant for propofol-based TIVA in procedures that necessitateintraoperative neurophysiological monitoring.
There is a paucity of literature comparing TIVA with magnesium sulphate and TIVA with dexmedetomidine in spine surgeries.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group D | Active comparator | Drug: Dexmedetomidine (Precedex®) |
| Group M | Active comparator | Drug: magnesium sulfate |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status I, II.
- Scheduled for elective spine surgery up to two levels under general anesthesia
Key exclusion criteria (10 listed)
- History of preoperative neuromuscular disease, hepatic impairment [defined as a known diagnosis of liver cirrhosis, hepatitis with elevated liver enzymes (>2 times upper standard limit), or Child-Pugh score B or C], renal impairment [defined as chronic kidney disease with an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m² or history of dialysis], endocrinal disorders [including uncontrolled diabetes mellitus (HbA1c >8.5%), thyroid dysfunction (untreated hypo/hyperthyroidism), or adrenal insufficiency], hematological disorder [such as anemia (Hb <10 g/dL), coagulopathies (INR >1.5, platelet count <100,000/mm³), or bleeding diathesis] or cardiovascular dysfunction [defined as history of ischemic heart disease, arrhythmias requiring treatment, heart failure (NYHA class II or higher), or uncontrolled hypertension (SBP >160 mmHg or DBP >100 mmHg)].
- Any degree of heart block.
- Known allergy to the study drugs.
- Scoliosis surgery.
- Cervical spine surgeries.
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 |
|---|---|---|
| Dexmedetomidine (Precedex®)Patients will receive a dexmedetomidine loading dose of 1 µg/kg before induction over a period of 15 min and maintenance of 0.5 µg/kg/h throughout the surgery | Drug | Group D |
| magnesium sulfatePatients will receive a magnesium sulfate loading dose of 50 mg/kg before induction over a period of 15 min and maintenance at 15 mg/kg/h throughout the surgery | Drug | Group M |
Primary outcome
Extubation time
Time frame: Up to 2 hours after surgery
Time from stoppage of TIVA infusion till extubation of the endotracheal tube
5 secondary outcomes
Time to the first request for the rescue analgesia
Time frame: Up to 24 hours after surgery
Total morphine consumption
Time frame: 24 hours postoperative
Ramsay Sedation score
Time frame: 24 hours postoperative
Degree of patient satisfaction
Time frame: 24 hours postoperative
Incidence of adverse events
Time frame: 24 hours postoperative
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 2 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine (Precedex®) and magnesium sulfate in people with Emergence From Anesthesia, run by Cairo 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 2 inclusion and 10 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 2 Mar 2026. 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extubation time (time frame: Up to 2 hours 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 2 Mar 2026.