Deep Neuromuscular Blockade in Strabismus Surgery
- Conditions
- Strabismus
- Interventions
- Other: moderate to deep neuromuscular blockadeOther: shallow to minimal neuromuscular blockade
- Registration Number
- NCT05882643
- Lead Sponsor
- Seoul National University Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 204
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description block group moderate to deep neuromuscular blockade * 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) control group 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)
- Primary Outcome Measures
Name Time Method The incidence of grade 2 or greater oculocardiac reflex (induced, during strabismus surgery) During induced oculocardiac reflex test by ophthalmologists \> 20% reduction in heart rate induced by intentional manipulation of the extraocular rectus muscle
- Secondary Outcome Measures
Name Time Method The incidence of grade 1 oculocardiac reflex (induced, during strabismus surgery) During induced oculocardiac reflex test by ophthalmologists \< 20% reduction in heart rate induced by intentional manipulation of the extraocular rectus muscle
Number of times Rescue IV Atropine has been used for oculocardiac reflex During general anesthesia for strabismus surgery (within 2 hour) Number of times Rescue IV Atropine has been used (0.02mg/kg) for oculocardiac reflex
Results from a refraction test before strabismus surgery Before strabismus surgery (within 12 month) Results from a refraction test before strabismus surgery measured at outpatient clinic
The incidence of grade 2 or greater oculocardiac reflex (during strabismus surgery) During general anesthesia for strabismus surgery (within 2 hour) \> 20% reduction in heart rate during strabismus surgery
Postoperative nausea/vomiting From extubation to post-anesthesia care unit stay (within 1 hour) Presence of postoperative nausea/vomiting as assessed in the recovery room
The incidence of grade 1 greater oculocardiac reflex (during strabismus surgery) During general anesthesia for strabismus surgery (usually within 2 hour) \< 20% reduction in heart rate during strabismus surgery
Results from a refraction test at strabismus surgery During general anesthesia for strabismus surgery (within 2 hour) Results from a refraction test during strabismus surgery
The incidence of hypotension During general anesthesia for strabismus surgery (within 2 hour) The incidence of hypotension, defined as a drop to 20% or more of baseline mean blood pressure
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of