Remimazolam for Emergence Delirium Prevention in Patients Undergoing Rhinoseptoplasty, FESS or Septoplasty
NCT ID: NCT06398275
Last Updated: 2024-05-03
Study Results
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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RECRUITING
PHASE2
80 participants
INTERVENTIONAL
2024-03-06
2024-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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1
Remimazolam 20 MG Injection [Byfavo]
Remimazolam 0.1 mg/kg intravenous injection
2
NaCl 0.9%
NaCl 0.9% 0.04 mL/kg
Interventions
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Remimazolam 20 MG Injection [Byfavo]
Remimazolam 0.1 mg/kg intravenous injection
NaCl 0.9%
NaCl 0.9% 0.04 mL/kg
Eligibility Criteria
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Inclusion Criteria
* ASA I or II
Exclusion Criteria
* patients treated with psychiatric medication (in the time of operation or 6 months prior to operation)
18 Years
65 Years
ALL
No
Sponsors
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University Hospital of Split
OTHER
Responsible Party
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Grgur Prižmić
MD
Locations
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UH Split
Split, , Croatia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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520-03/24-01/14
Identifier Type: -
Identifier Source: org_study_id
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