NCT07064720

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2024

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 12, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 15, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2025

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2026

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

1.4 years

First QC Date

July 6, 2025

Last Update Submit

January 17, 2026

Conditions

Dexmedetomidine

Keywords

dexmedetomidinemannitol

Outcome Measures

Primary Outcomes (1)

  • optic nerve sheath diameter

    90 minutes

Secondary Outcomes (3)

  • Postoperative neurologic complications

    24 HOURS

  • Postoperative cardiac complications

    24 hours

  • Duration of hospital stay

    30 days

Study Arms (2)

Group (D)

EXPERIMENTAL

Dexmedetomidine with Mannitol

Drug: Dexmedetomidine with Mannitol

Group (M)

EXPERIMENTAL

Mannitol only

Drug: Mannitol (20%)

Interventions

Dexmedetomidine with MannitolDRUG

receive 1 mcg/kg of dexmedetomidine added to 0.4 mcg/kg of mannitol

Group (D)
Mannitol (20%)DRUG

receive 0.5 g/kg of mannitol

Group (M)

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

facility of medicine Cairo university

Cairo, 12613, Egypt

Location

MeSH Terms

Interventions

DexmedetomidineMannitol

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsSugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of anesthesia, SICU & and pain management

Study Record Dates

First Submitted

July 6, 2025

First Posted

July 15, 2025

Study Start

July 12, 2024

Primary Completion

December 22, 2025

Study Completion

January 15, 2026

Last Updated

January 21, 2026

Record last verified: 2026-01

Locations

EG(1)