Adding Dexmedetomidine to Mannitol to Attenuate the Incre... | NCT07064720

Studies
Adding Dexmedetomidine to Mannitol to Attenuate the Increase of Intracranial Pressure

NCT07064720

Sponsor

Cairo University

Status

Completed

Last Update Posted

Jan 21, 2026Actual

Enrollment

60Actual

Phase

Phase 2Phase 3

Conditions

Dexmedetomidine

Interventions

Dexmedetomidine with Mannitol
Mannitol (20%)

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 12, 2024Actual

Primary Completion Date

Dec 22, 2025Actual

Completion Date

Jan 15, 2026Actual

First Submitted Date

Jul 6, 2025

First Submission Date that Met QC Criteria

Jul 6, 2025

First Posted Date

Jul 15, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 17, 2026

Last Update Posted Date

Jan 21, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Amr Samir Wahdan, Assistant Professor of anesthesia, SICU & and pain management, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group (D)	Experimental	Dexmedetomidine with Mannitol	Drug: Dexmedetomidine with Mannitol
Group (M)	Experimental	Mannitol only	Drug: Mannitol (20%)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexmedetomidine with Mannitol	Drug	receive 1 mcg/kg of dexmedetomidine added to 0.4 mcg/kg of mannitol	Group (D)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
optic nerve sheath diameter		90 minutes

Secondary Outcomes

Measure	Description	Time Frame
Postoperative neurologic complications		24 HOURS
Postoperative cardiac complications		24 hours
Duration of hospital stay

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA I-II Patients scheduled for elective robot-assisted laparoscopic prostatectomy

Exclusion Criteria:

• ASA physical status > II
- Cardiac patients
- Cerebrovascular disease
- Glaucoma
- Hepatic failure
- Renal failure
- 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
facility of medicine Cairo university		Cairo		12613	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020927	Dexmedetomidine
D008353	Mannitol

Ancestor Terms

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided