Deep Neuromuscular Blockade in Strabismus Surgery

NCT ID: NCT05882643

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-28

Study Completion Date

2026-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine if inducing a moderate or greater neuromuscular block (TOF count 0-3) when performing a neuromuscular block in pediatric patients aged 3 to 18 years undergoing strabismus surgery under general anesthesia can reduce the incidence of the oculocardiac reflex.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Strabismus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

block group

* Maintaining moderate to deep neuromuscular blockade during an intraoperative period (Train-of-four 0-3, post-tetanic count \> 1)
* Rocuronium (intravenous, 1.0 mg/kg)

Group Type EXPERIMENTAL

moderate to deep neuromuscular blockade

Intervention Type OTHER

* Maintaining moderate to deep neuromuscular blockade during an intraoperative period (Train-of-four 0-3 count, post-tetanic count \> 1)
* Rocuronium (intravenous, 1.0 mg/kg at induction period)

control group

* Maintaining shallow to minimal neuromuscular blockade during an intraoperative period (Train-of-four 4, post-tetanic count \< 0.9)
* Rocuronium (intravenous, 0.3 mg/kg)

Group Type ACTIVE_COMPARATOR

shallow to minimal neuromuscular blockade

Intervention Type OTHER

* Maintaining shallow to minimal neuromuscular blockade during an intraoperative period (Train-of-four 4, post-tetanic count \< 0.9)
* Rocuronium (intravenous, 0.3 mg/kg at induction period)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

moderate to deep neuromuscular blockade

* Maintaining moderate to deep neuromuscular blockade during an intraoperative period (Train-of-four 0-3 count, post-tetanic count \> 1)
* Rocuronium (intravenous, 1.0 mg/kg at induction period)

Intervention Type OTHER

shallow to minimal neuromuscular blockade

* Maintaining shallow to minimal neuromuscular blockade during an intraoperative period (Train-of-four 4, post-tetanic count \< 0.9)
* Rocuronium (intravenous, 0.3 mg/kg at induction period)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Pediatric patients between the ages of 3 and 18 who are American Society of Anesthesiologists physical classification (ASA) I, II, or III scheduled for strabismus surgery under general anesthesia.

Exclusion Criteria

* Patients with underlying cardiovascular disease
* Patients with preoperative electrocardiograms showing conduction disturbances
* Patients with neuromuscular disease
* Any other patient who, in the opinion of the investigator, is not a good candidate for the study.
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Young-Eun Jang

Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Young-Eun Jang, MD, PhD

Role: primary

82-2-2072-3650

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H-2303-079-1412

Identifier Type: -

Identifier Source: org_study_id