Remimazolam for Emergence Delirium Prevention in Children... | NCT07704437

Studies
Remimazolam for Emergence Delirium Prevention in Children Undergoing Tonsillectomy

NCT07704437

Sponsor

University Hospital of Split

Status

Completed

Last Update Posted

Jul 15, 2026Actual

Enrollment

110Actual

Phase

Phase 1

Conditions

Remimazolam
Tonsillectomy
Emergence Delirium

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

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2024Actual

Primary Completion Date

Jul 15, 2025Actual

Completion Date

May 5, 2026Actual

First Submitted Date

Jul 7, 2026

First Submission Date that Met QC Criteria

Jul 14, 2026

First Posted Date

Jul 15, 2026Actual

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

Jul 14, 2026

Last Update Posted Date

Jul 15, 2026Actual

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 study is to confirm the effectiveness of remimazolam in preventing delirium during emergence from anesthesia in children who will undergo elective procedures of tonsillectomy, adenotonsillectomy or adenoidectomy, aged 3-12 years, American Society of Anesthesiologists (ASA) physical status I. Children will be anesthetized with balanced anesthesia, maintained with sevoflurane and will be randomized in two groups. The first group will receive remimazolam before anesthesia, while the second will receive normal saline, both intravenously.

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

Detailed Description

The aim of this study is to confirm the effectiveness of remimazolam in preventing delirium during emergence from anesthesia in children who will undergo elective procedures of tonsillectomy, adenotonsillectomy or adenoidectomy, aged 3-12 years, ASA classification I. Children will be anesthetized with balanced anesthesia, maintained with sevoflurane and will be randomized in two groups. The first group will receive remimazolam before anesthesia, while the second will receive normal saline, both intravenously.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Remimazolam	Experimental		Drug: Remimazolam 20 MG Injection [Byfavo]
NaCl 0,9 %	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	Remimazolam

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PAED (pediatric anesthesia emergence delirium scale)	The PAED scale consists of 5 criteria that are scored using a 5-point scale. A score greater than 10 (or greater than 12) represents emergence delirium.	Perioperative - immediately after extubation and 3 times after that every 10 minutes

Secondary Outcomes

Measure	Description	Time Frame
FLACC ( Face, Legs, Activity, Cry, Consolability scale for assessing pain)	The scale is scored from 0 to 10, where 0 represents no pain and higher scores indicate greater pain.	Perioperative - immediately after extubation and 3 times after that every 10 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

American Society of Anesthesiologists (ASA) physical status I
Children undergoing scheduled tonsillectomy/adenoidectomy or combined procedure

Exclusion Criteria:

American Society of Anesthesiologists (ASA) physical status > 1
Known hypersensitivity to remimazolam or other benzodiazepines

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Filip Peris	University Hospital of Split	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
UH Split		Split	Split-Dalmatia County	21000	Croatia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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

ID	Term
C522201	remimazolam
D007267	Injections

ID	Term
D004333	Drug Administration Routes
D004358	Drug Therapy
D013812	Therapeutics