NCT05260320|Recruiting
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Sponsor study identifier
interventional
50
1 country
1
Study Start
May 2, 2025
Actual (reported)Primary Completion
February 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2, 2022
Actual (reported)March 2, 2022
Actual (reported)May 2, 2025
Actual (reported)February 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Postoperative pain
The degree (as ranked on a scale from 1-10) and duration of postoperative pain, including necessity of postoperative analgesia
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 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
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
Preop considerations 1\. Ensure CBC, PT, PTT, type and cross are available, if not obtain with preop IV access Premed 1. Acetaminophen PO 15mg/kg 2. Scopolamine patch as indicated 3. Midazolam as indicated PO or IV Induction 1. Standard induction with 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) - surgical team will suture to nasal septum 5. Place an additional PIV, ideally large gauge for volume resuscitation (18g or 16g) 6. Dexamethasone 4-8mg q4-6 hours per surgical request 7. Tranexamic acid 30mg/kg bolus (over 15 minutes) 8. Ancef 30 mg/kg bolus Monitors /Access 1. Standard ASA monitors 2. Avoid placing nasal or oral temperature probe as this interferes with surgical exposure 3. PIV x 2 is sufficient, have at least one large gauge PIV for volume resuscitation 4. Arterial catheter not necessary but place as needed, especially if patient is medically compl
See information in intervention group description
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Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
SADOVE MS. Anesthetic management for maxillofacial surgery. Ill Med J. 1956 Nov;110(5):227-31. No abstract available.
Lucin Yagual TA, Vivanco Murillo SM, Espinoza Daquilema NV, Mariscal Garcia RS, Dick Paredes DF. Smooth Extubation Techniques in Pediatric Patients After LeFort I Osteotomy. Cureus. 2021 Apr 24;13(4):e14659. doi: 10.7759/cureus.14659.
Krishna SG, Bryant JF, Tobias JD. Management of the Difficult Airway in the Pediatric Patient. J Pediatr Intensive Care. 2018 Sep;7(3):115-125. doi: 10.1055/s-0038-1624576. Epub 2018 Jan 28.
Robin Yang, MD, DDS
Johns Hopkins University
First Submitted
February 2, 2022
First Posted
March 2, 2022
Study Start
May 2, 2025
Actual (reported)Primary Completion
February 2027
Gastrectomy at Low Pressure Trial - (GALPT)
Contact the study team to confirm eligibility.
Gleizal A, Di Rocco F, Chauvel-Picard J. Indications of Lefort osteotomies for facial deformities induced by craniosynostosis. Neurochirurgie. 2019 Nov;65(5):279-285. doi: 10.1016/j.neuchi.2019.10.002. Epub 2019 Oct 16. No abstract available.
Tewari A, Singh G, Mishra M, Gaur A, Mallan D. Comparative Evaluation of Hypotensive and Normotensive Anesthesia on LeFort I Osteotomies: A Randomized, Double-Blind, Prospective Clinical Study. J Maxillofac Oral Surg. 2020 Jun;19(2):240-245. doi: 10.1007/s12663-019-01325-7. Epub 2020 Jan 17.
Wong GB, Nargozian C, Padwa BL. Anesthetic concerns of external maxillary distraction osteogenesis. J Craniofac Surg. 2004 Jan;15(1):78-81. doi: 10.1097/00001665-200401000-00022.
Posnick JC, Choi E, Chavda A. Operative Time, Airway Management, Need for Blood Transfusions, and In-Hospital Stay for Bimaxillary, Intranasal, and Osseous Genioplasty Surgery: Current Clinical Practices. J Oral Maxillofac Surg. 2016 Mar;74(3):590-600. doi: 10.1016/j.joms.2015.07.026. Epub 2015 Aug 5.
Lopez MM, Zech D, Linton JL, Blackwell SJ. Dexmedetomidine Decreases Postoperative Pain and Narcotic Use in Children Undergoing Alveolar Bone Graft Surgery. Cleft Palate Craniofac J. 2018 May;55(5):688-691. doi: 10.1177/1055665618754949. Epub 2018 Feb 15.
Precious DS, McFadden LR, Fitch SJ. Orthognathic surgery for children. Analysis of 88 consecutive cases. Int J Oral Surg. 1985 Dec;14(6):466-71. doi: 10.1016/s0300-9785(85)80051-x.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 20, 2026
Record last verified: 2026-05
IPD will be shared with those conducting research data collection and analysis, and IPD that underlie results in a publication will be published.
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Source: ClinicalTrials.gov.
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