Deep Neuromuscular Blockade in Strabismus Surgery

Seoul National University

Status: Enrolling

Conditions: Strabismus

Treatments: Other: moderate to deep neuromuscular blockade; Other: shallow to minimal neuromuscular blockade

Study type: Interventional

Funder types: Other

Identifiers

NCT05882643

H-2303-079-1412

Details and patient eligibility

About

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.

Enrollment: 204 estimated patients

Sex: All

Ages: 3 to 18 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

204 participants in 2 patient groups

block group

Experimental group

Description:

* 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)

Treatment:

Other: moderate to deep neuromuscular blockade

control group

Active Comparator group

Description:

* 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)

Treatment:

Other: shallow to minimal neuromuscular blockade