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

NCT06398275 | Unknown Phase 2

• 1 other identifier: 520-03/24-01/14
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Remimazolam; Emergence Delirium; Rhinoplasty

Keywords

Remimazolam

Outcome Measures

Primary Outcomes (1)

• Richmond agitation sedation scale

  Immediately after extubation and every five minutes after that for half hour

Study Arms (2)

1

EXPERIMENTAL

Drug: Remimazolam 20 MG Injection [Byfavo]

2

PLACEBO COMPARATOR

Drug: NaCl 0.9%

Interventions

Remimazolam 20 MG Injection [Byfavo] DRUG

Remimazolam 0.1 mg/kg intravenous injection

1

NaCl 0.9% DRUG

NaCl 0.9% 0.04 mL/kg

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital of Split: lead

Study Sites (1)

UH Split

Split, Croatia

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Interventions

remimazolam; Injections; Sodium Chloride

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Grgur Prižmić

CONTACT

+385994213808; gregorio.prizmic@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 3, 2024
• Study Start: March 6, 2024
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 3, 2024

Record last verified: 2024-01

Locations

CR (1)