DexmedetomidinePhase 2/3NCT07064720
Adding Dexmedetomidine to Mannitol to Attenuate the Increase of Intracranial Pressure
A Phase 2/3 study testing Dexmedetomidine with Mannitol and Mannitol (20%) in people with Dexmedetomidine, run by Cairo University at 1 site in Egypt.
Trial summary
Dexmedetomidine is a potent alpha-2 adrenergic receptor agonist. In addition, dexmedetomidine-induced stimulation of the postsynaptic alpha-2 adrenergic receptor on the cerebral blood vessels can cause cerebral vasoconstriction and decrease cerebral blood flow Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Dexmedetomidine
- What is being tested?
- Dexmedetomidine with Mannitol and Mannitol (20%)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jul 2024to 15 Jan 2026
- Phase
- Phase 2/3
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-II Patients scheduled for elective robot-assisted laparoscopic prostatectomy
Who cannot join
- • ASA physical status > II
- Cardiac patients
- Cerebrovascular disease
- Glaucoma
- Hepatic failure
- Renal failure
Show all 10Show fewer
- History of anaphylactic reaction to dexmedetomidine or mannitol
- Hemodynamic instability
- Cannot measure ONSD for example due to ophthalmological problems.
- Any cause of preoperative increase in ICP for example intracranial space occupying lesions.
Trial locations and contacts
1 site in 1 country.
About this study
Dexmedetomidine is a potent alpha-2 adrenergic receptor agonist. In addition, dexmedetomidine-induced stimulation of the postsynaptic alpha-2 adrenergic receptor on the cerebral blood vessels can cause cerebral vasoconstriction and decrease cerebral blood flow
- Conditions
- Dexmedetomidine
- Being tested
- Dexmedetomidine with Mannitol, Mannitol (20%)
- Keywords
- dexmedetomidine, mannitol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine with MannitolDrug
receive 1 mcg/kg of dexmedetomidine added to 0.4 mcg/kg of mannitol
Mannitol (20%)Drug
receive 0.5 g/kg of mannitol
| Study group | Role | What they receive |
|---|---|---|
| Group (D) | Experimental | Dexmedetomidine with Mannitol Receives: Drug: Dexmedetomidine with Mannitol |
| Group (M) | Experimental | Mannitol only Receives: Drug: Mannitol (20%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
optic nerve sheath diameter
Measured: 90 minutes
Secondary outcomes (3)
Postoperative neurologic complications
Measured: 24 HOURS
Postoperative cardiac complications
Measured: 24 hours
Duration of hospital stay
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start12 Jul 2024
- Primary completion22 Dec 2025
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DexmedetomidineStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Samir Wahdan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07064720
- Sponsor's protocol ID
- MS-50-2024
- Status last verified
- Jan 2026
- First submitted
- 6 Jul 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adding Dexmedetomidine to Mannitol to Attenuate the Increase of Intracranial Pressure
- ClinicalTrials.gov ID
- NCT07064720
- Acronym / sponsor ID
- MS-50-2024
- Conditions
- Dexmedetomidine
- Keywords
- dexmedetomidine, mannitol
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Jul 2024 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 15 Jul 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.
Dexmedetomidine is a potent alpha-2 adrenergic receptor agonist. In addition, dexmedetomidine-induced stimulation of the postsynaptic alpha-2 adrenergic receptor on the cerebral blood vessels can cause cerebral vasoconstriction and decrease cerebral blood flow
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (D) | Experimental | Drug: Dexmedetomidine with MannitolDexmedetomidine with Mannitol |
| Group (M) | Experimental | Drug: Mannitol (20%)Mannitol only |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA I-II Patients scheduled for elective robot-assisted laparoscopic prostatectomy
Key exclusion criteria (10 listed)
- • ASA physical status > II
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 with Mannitolreceive 1 mcg/kg of dexmedetomidine added to 0.4 mcg/kg of mannitol | Drug | Group (D) |
| Mannitol (20%)receive 0.5 g/kg of mannitol | Drug | Group (M) |
Primary outcome
optic nerve sheath diameter
Time frame: 90 minutes
3 secondary outcomes
Postoperative neurologic complications
Time frame: 24 HOURS
Postoperative cardiac complications
Time frame: 24 hours
Duration of hospital stay
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Dexmedetomidine
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Not yet recruiting
Adding Different Doses of Dexmedetomidine to Bupivecaine in Erector Spinae Plane Block
Postoperative Pain in Lumbar Spine Surgery
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
Recruiting
Three Variants of the PENG Block With and Without Perineural Adjuvants in Older Adults
Hip Osteoarthritis
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dexmedetomidine with Mannitol and Mannitol (20%) in people with Dexmedetomidine, run by Cairo University at 1 site in Egypt.
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 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: finished, as of the sponsor's last update on 21 Jan 2026. 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 Egypt. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
optic nerve sheath diameter (time frame: 90 minutes). 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 21 Jan 2026.