Adding Dexmedetomidine to Mannitol to Attenuate the Increase of Intracranial Pressure

Cairo University (CU)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Dexmedetomidine

Treatments: Drug: Mannitol (20%); Drug: Dexmedetomidine with Mannitol

Study type: Interventional

Funder types: Other

Identifiers

NCT07064720

MS-50-2024

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Group (D)

Experimental group

Description:

Dexmedetomidine with Mannitol

Treatment:

Drug: Dexmedetomidine with Mannitol

Group (M)

Experimental group

Description:

Mannitol only

Treatment:

Drug: Mannitol (20%)