Remimazolam for Emergence Delirium Prevention in Patients... | NCT06398275

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

NCT06398275

Sponsor

University Hospital of Split

Status

Unknown status

Last Update Posted

May 3, 2024Actual

Enrollment

80Estimated

Phase

Phase 2

Conditions

Remimazolam
Emergence Delirium
Rhinoplasty

Interventions

Remimazolam 20 MG Injection [Byfavo]
NaCl 0.9%

Countries

Croatia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 6, 2024Actual

Primary Completion Date

Sep 2024Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

Apr 29, 2024

First Submission Date that Met QC Criteria

May 2, 2024

First Posted Date

May 3, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 2, 2024

Last Update Posted Date

May 3, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: Remimazolam 20 MG Injection [Byfavo]
2	Placebo Comparator		Drug: NaCl 0.9%

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Remimazolam 20 MG Injection [Byfavo]	Drug	Remimazolam 0.1 mg/kg intravenous injection	1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Grgur Prižmić	Contact	+385994213808		gregorio.prizmic@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UH Split	Recruiting	Split			Croatia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41892844	Derived	Prizmic G, Peris F, Jozeljic Pesic M, Mitar AM, Bego A, Perkovic SP, Stojanovic Stipic S. Remimazolam Bolus Prevents Emergence Agitation After Rhinologic Surgery: A Randomized, Triple-Blind, Controlled Trial. Med Sci (Basel). 2026 Mar 10;14(1):129. doi: 10.3390/medsci14010129.

ID	Term
D003693	Delirium
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations

ID	Term
C522201	remimazolam
D007267	Injections
D012965	Sodium Chloride

ID	Term
D004333	Drug Administration Routes
D004358	Drug Therapy
D013812	Therapeutics
D002712	Chlorides