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

May 2, 2024 updated by: Grgur Prižmić, University Hospital of Split

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Remimazolam 20 MG Injection [Byfavo]
Remimazolam 0.1 mg/kg intravenous injection
Placebo Comparator: 2
Drug: NaCl 0.9%
NaCl 0.9% 0.04 mL/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Richmond agitation sedation scale
Time Frame: Immediately after extubation and every five minutes after that for half hour
Immediately after extubation and every five minutes after that for half hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Split

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

April 29, 2024

First Submitted That Met QC Criteria

May 2, 2024

First Posted (Actual)

May 3, 2024

Study Record Updates

Last Update Posted (Actual)

May 3, 2024

Last Update Submitted That Met QC Criteria

May 2, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 520-03/24-01/14

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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