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This study aims to investigate the impact of varying degrees of neuromuscular blockade on postoperative pain in pediatric patients aged over 2 months to under 7 years undergoing laparoscopic surgery under general anesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| moderate neuromuscular blockade | Active Comparator |
| |
| deep neuromuscular blockade | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rocuronium 0.2 mg/kg/hr continuous infusion | Drug | To maintain Train-of-four count 1 to 3 during surgery: Administration of continuous infusion of rocuronium at a rate of 0.2 mg/kg/hr to achieve and sustain moderate neuromuscular blockade. |
| Measure | Description | Time Frame |
|---|---|---|
| ANIm (Analgesia Nociception Index) Value | 30 minutes after arrival in the recovery room |
| Measure | Description | Time Frame |
|---|---|---|
| FLACC Pain Scale | 30 minutes after arrival in the recovery room | |
| Pediatric Anesthesia Emergence Delirium Scale | 30 minutes after arrival in the recovery room | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Assistant | Contact | 82-2-2072-3664 | snuh.pedane@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SNUCH | Recruiting | Seoul | Seoul | South Korea |
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| ID | Term |
|---|---|
| D000077123 | Rocuronium |
| ID | Term |
|---|---|
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| rocuronium 0.6 mg/kg/hr continuous infusion | Drug | To maintain Train-of-four count 0 during surgery: Administration of continuous infusion of rocuronium at a rate of 0.6 mg/kg/hr to achieve and sustain deep neuromuscular blockade. |
|
| Time to Extubation |
| From end of surgery to extubation (in minutes, assessed up to 1 hour) |
| Recovery Room Length of Stay | Duration of stay in the recovery room (in minutes, assessed up to 2 hours) |
| Remifentanil Consumption During Anesthesia | mcg/kg/min | During surgery ( assessed up to 5 hours) |
| Change in Pain Score (FLACC Pain Scale) | Every 6 hours up to 24 hours post-surgery |
| Maximum Pain Score (FLACC Pain Scale) within 24 Hours | Within 24 hours post-surgery |
| Total Narcotic/Non-Narcotic Analgesic Consumption per Body Weight | Within 24 hours post-surgery |
| Peak Intraabdominal Pressure During Surgery | During surgery (assessed up to 5 hours) |
| Peak Inspiratory Pressure During Surgery | During surgery (assessed up to 5 hours) |
| Leiden Surgical Rating Scale | During surgery (assessed up to 5 hours) |
| Events During Recovery (Agitation, Stridor, Desaturation < 95%, Nausea, Vomiting, Bradycardia, Oxygen Requirement) | During recovery room stay (assessed up to 2 hours) |
| Any complications Occurring Before Discharge | Up to discharge (assessed up to 1 month) |
| D011083 |
| Polycyclic Compounds |