Remimazolam for Emergence Delirium Prevention in Patients Undergoing Rhinoseptoplasty, FESS or Septoplasty

Last updated: May 2, 2024
Sponsor: University Hospital of Split
Overall Status: Active - Recruiting

Phase

2

Condition

Dementia

Treatment

Remimazolam 20 MG Injection [Byfavo]

NaCl 0.9%

Clinical Study ID

NCT06398275
520-03/24-01/14
  • Ages 18-65
  • All Genders

Study Summary

The aim of this research is to confirm the effectiveness of remimazolam in preventing delirium during recovery from anesthesia in adult patients who have undergone one of the rhinological surgeries (septoplasty, rhinoseptoplasty or functional endoscopic sinus surgery).

Patients aged 18-65, ASA classification I-II will be anesthetized with balanced anesthesia maintained with sevoflurane and will be randomized into two groups. The first group will receive remimazolam before anesthesia, while the second will receive normal saline solution.

The main outcome of the study will be the presence/absence of delirium during anesthesia recovery, while the secondary outcome will be the postoperative pain level, the length of stay in the recovery room, the presence of unwanted events in the recovery room, and the presence of postoperative mood changes.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients scheduled for rhinoplasty, rhinoseptoplasty or FESS
  • ASA I or II

Exclusion

Exclusion Criteria:

  • pregnancy
  • patients treated with psychiatric medication (in the time of operation or 6 monthsprior to operation)

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Remimazolam 20 MG Injection [Byfavo]
Phase: 2
Study Start date:
March 06, 2024
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • UH Split

    Split,
    Croatia

    Active - Recruiting

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