Deep Neuromuscular Blockade in Strabismus Surgery

Strabismus Clinical Trial

Official title:

The Effect of the Deep Neuromuscular Block on the Refraction and the Oculocardiac Reflex During Strabismus Surgery in Pediatric Patients - a Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05882643
• Other study ID #: H-2303-079-1412
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: April 2024
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 204
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Strabismus

Intervention

Other:
• 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)
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of grade 2 or greater oculocardiac reflex (induced)	> 20% reduction in heart rate induced by intentional manipulation of the inferior rectus muscle	During induced oculocardiac reflex test by ophthalmologists
Secondary	The incidence of grade 1 oculocardiac reflex (induced)	< 20% reduction in heart rate induced by intentional manipulation of the inferior rectus muscle	During induced oculocardiac reflex test by ophthalmologists
Secondary	The incidence of grade 2 or greater oculocardiac reflex (during strabismus surgery)	> 20% reduction in heart rate during strabismus surgery	During general anesthesia for strabismus surgery (within 2 hour)
Secondary	The incidence of grade 1 greater oculocardiac reflex (during strabismus surgery)	< 20% reduction in heart rate during strabismus surgery	During general anesthesia for strabismus surgery (usually within 2 hour)
Secondary	Number of times Rescue IV Atropine has been used for oculocardiac reflex	Number of times Rescue IV Atropine has been used (0.02mg/kg) for oculocardiac reflex	During general anesthesia for strabismus surgery (within 2 hour)
Secondary	The incidence of hypotension	The incidence of hypotension, defined as a drop to 20% or more of baseline mean blood pressure	During general anesthesia for strabismus surgery (within 2 hour)
Secondary	Postoperative nausea/vomiting	Presence of postoperative nausea/vomiting as assessed in the recovery room	From extubation to post-anesthesia care unit stay (within 1 hour)