Adding Dexmedetomidine to Mannitol to Attenuate the Increase of Intracranial Pressure

NCT ID: NCT07064720

Last Updated: 2026-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-12

Study Completion Date

2026-01-15

Brief Summary

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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

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Conditions

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Dexmedetomidine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group (D)

Dexmedetomidine with Mannitol

Group Type EXPERIMENTAL

Dexmedetomidine with Mannitol

Intervention Type DRUG

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

Group (M)

Mannitol only

Group Type EXPERIMENTAL

Mannitol (20%)

Intervention Type DRUG

receive 0.5 g/kg of mannitol

Interventions

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Dexmedetomidine with Mannitol

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

Intervention Type DRUG

Mannitol (20%)

receive 0.5 g/kg of mannitol

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Amr Samir Wahdan

Assistant Professor of anesthesia, SICU & and pain management

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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facility of medicine Cairo university

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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MS-50-2024

Identifier Type: -

Identifier Source: org_study_id

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