Effect of Remimazolam and Sevoflurane Anesthesia on Recov... | NCT06053489

Studies
Effect of Remimazolam and Sevoflurane Anesthesia on Recovery in Pediatric Patients

NCT06053489

Sponsor

Pusan National University Yangsan Hospital

Status

Completed

Last Update Posted

Nov 1, 2024Actual

Enrollment

146Actual

Phase

Not provided

Conditions

Ophthalmic Abnormalities
Pediatric Disorder

Interventions

general anesthesia with remimazolam

Countries

South Korea

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

Oct 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

Jul 31, 2023Actual

Primary Completion Date

Aug 31, 2024Actual

Completion Date

Aug 31, 2024Actual

First Submitted Date

Sep 9, 2023

First Submission Date that Met QC Criteria

Sep 22, 2023

First Posted Date

Sep 25, 2023Actual

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

Oct 30, 2024

Last Update Posted Date

Nov 1, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kim Hee Young, Assistant professor for fund, Pusan National University Yangsan HospitalPrincipal Investigator

Lead Sponsor

Pusan National University Yangsan HospitalOTHER

Collaborators

Not provided

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 most commonly used anesthetic for general anesthesia in pediatric patients is sevoflurane, an inhalation anesthetic. However, the incidence of emergence agitation after sevoflurane anesthesia in pediatric patients is high, with reports of up to 67%. Remimazolam (Byfavo Inj., Hana Pharm Col, Ltd., Seoul, Korea) has a short context-sensitive half-life of 7.5 minutes, and the time it takes from the end of anesthesia until the patient wakes up is predictable. According to a study by Yang X et al., administering a small amount of remimazolam (0.2 mg/kg) intravenously at the end of general anesthesia using sevoflurane reduced the incidence of emergence agitation. However, very few studies have evaluated the use of remimazolam in general anesthesia in pediatric patients.

Detailed Description

The most commonly used anesthetic for general anesthesia in pediatric patients is sevoflurane, an inhalation anesthetic. It has the advantage of being able to induce anesthesia without securing an intravenous route and causing less irritation to the airway. However, the incidence of emergence agitation after sevoflurane anesthesia in pediatric patients is high, with reports of up to 67%. Emergence agitation can cause physical damage to the patient, workload in the recovery room, and dissatisfaction of the caregiver.
Remimazolam (Byfavo Inj., Hana Pharm Col, Ltd., Seoul, Korea) is a benzodiazepine drug used for inducing and maintaining general anesthesia and for sedation during procedures. When remimazolam is used as a general anesthetic, it has the advantage of being metabolized quickly by enzymes in the liver compared to propofol, has a short context-sensitive half-life of 7.5 minutes, and can be reversed with flumazenil. Therefore, during general anesthesia using remimazolam, the time it takes from the end of anesthesia until the patient wakes up is predictable. According to a study by Yang X et al., administering a small amount of remimazolam (0.2 mg/kg) intravenously at the end of general anesthesia using sevoflurane reduced the incidence of emergence agitation.
However, very few studies have evaluated the use of remimazolam in general anesthesia in pediatric patients and its effect on endotracheal extubation time after anesthesia in operating room, emergence agitation, pain, and discharge time in the postanesthesia care unit (PACU).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

146Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
general anesthesia with remimazolam	Other	general anesthesia with remimazolam in pediatric patients undergoing ophthalmic surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to extubation	Time to extubation after the end of general anesthesia	Immediate after the end of general anesthesia

Secondary Outcomes

Measure	Description	Time Frame
Time for post-anesthesia recovery	Time taken until the patient can leave the PACU. The post-anesthesia recovery score (modified Aldrete score) is used for assessment of patient's activity, respiration, blood pressure, consciousness, and peripheral oxygen saturation. A score 9 points or more is required for discharge from the PACU.	From the time of immediate after entering the PACU until until achieving post-anesthesia recovery score of 9 or more, assessed up to 4 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients aged between 3 and 18 years old who underwent ophthalmic surgery under general anesthesia
When anesthesia was induced and maintained with remimazolam, or anesthesia was induced with propofol and maintained with sevoflurane.

Exclusion Criteria:

- none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Patients aged between 3 and 18 years old who underwent ophthalmic surgery under general anesthesia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hee Young Kim, MD, PhD	Pusan National University Yangsan Hospital, Yangsan, South Korea	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pusan National University Yangsan Hospital		Yangsan			South Korea

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

Intervention Browse Module

MeSH Terms

ID	Term
D000768	Anesthesia, General
C522201	remimazolam

Ancestor Terms

ID	Term
D000758	Anesthesia
D000760	Anesthesia and Analgesia

Browse Leaves

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Browse Branches

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