Anesthetic Optimization in Pediatric LeFort Surgeries

Not Applicable

Not yet recruiting

• Conditions: Pain, Postoperative; Le Fort
• Interventions: Other: Standardized Anesthetic Course from Premedication to Induction

• Registration Number: NCT05260320
• Lead Sponsor: Johns Hopkins University

Brief Summary

This study will propose and evaluate a standardized LeFort osteotomy anesthetic protocol for pediatric patients at Johns Hopkins Hospital. There are two cohorts to this study: a prospective cohort who will receive the study anesthesia protocol and a historical cohort that received standard of care. The investigators hope this will help to minimize unnecessary postoperative pain management, inpatient stay, and long-term morbidity and mortality in these patients.

Detailed Description

This study will propose and evaluate a standardized LeFort osteotomy anesthetic protocol for pediatric patients at Johns Hopkins Hospital. There are two cohorts to this study: a prospective cohort who will receive the study anesthesia protocol and a historical cohort that received standard of care. The investigators hypothesize that implementation of this standardized protocol will show improved surgical outcomes among these patients as compared to current (discretionary) treatment. This study aims to optimize the anesthetic management of these patients in order to minimize postoperative pain management, inpatient stay, and long-term morbidity and mortality in these complex patients.

Study Timeline

• Study First Submitted: 2022-02-02
• Study First Submitted QC: 2022-02-18
• Study First Posted: 2022-03-02
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10
• Study Start: 2025-02-01
• Primary Completion: 2027-02
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Undergoing Le Fort osteotomy at Johns Hopkins Hospital
• Age >= 14 years

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Exclusion Criteria

• Contraindications to standardized anesthetic protocol (intervention arm)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Standardized Protocol	Standardized Anesthetic Course from Premedication to Induction	Premed 1. Acetaminophen PO 15mg/kg 2. Scopolamine patch + PO/IV Midazolam as needed Induction 1. Lidocaine (1.5 mg/kg), propofol (1-3 mg/kg), and rocuronium (0.6mg/kg) 2. Fentanyl 100 mcg bolus 3. Dexmedetomidine 0.3 mcg/kg bolus 4. Nasotracheal intubation (NTI) 5. Dexamethasone 4-8mg q4-6 hours 6. Tranexamic acid 30mg/kg bolus 7. Ancef 30 mg/kg bolus Room 1. Bolus line 2. 4 Channel/pump infusion line w/: Maintenance IVFs/Carrier, Dexmedetomidine, TXA, Precedex or Phenylephrine Maintenance 1. Sevo/isoflurane at 0.5-0.7 MAC with rocuronium boluses as needed 2. Dexmedetomidine 0.3- 0.5 mcg/kg/hour 3. Fentanyl 50 mcg boluses 4. TXA 15 mg/kg/hr 5. Phenylephrine 0.2-1 mcg/kg/min as needed Emergence 1. Stop dexmedetomidine before emergence 2. Re-dose acetaminophen 15 mg/kg IV 3. Toradol 0.5 mg/kg 4. Zofran 0.15 mg/kg 5. Reverse with sugammadex 6. OGT placement, extubate awake

Primary Outcome Measures

Name	Time	Method
Postoperative pain	From hospital admission (on day of surgery) to discharge, which is expected to last 2-7 days though may be up to 30 days	The degree (as ranked on a scale from 1-10) and duration of postoperative pain, including necessity of postoperative analgesia

Secondary Outcome Measures

Name	Time	Method
Length of stay	From hospital admission (on day of surgery) to discharge, which is expected to last 2-7 days though may be up to 30 days	Length of inpatient stay (in days)
Critical care utilization	From hospital admission (on day of surgery) to discharge, which is expected to last 2-7 days though may be up to 30 days	Utilization, and, where appropriate, length of use of the following: ICU, ventilatory support, intubation, blood products

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States