Back to resultsAnesthetic Optimization in Pediatric LeFort Surgeries
Primary Purpose
Le Fort, Pain, Postoperative
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standardized Anesthetic Course from Premedication to Induction
Sponsored by
About this trial
This is an interventional prevention trial for Le Fort
Eligibility Criteria
Inclusion Criteria:
- Undergoing Le Fort osteotomy at Johns Hopkins Hospital
- Age >= 14 years
Exclusion Criteria:
- Contraindications to standardized anesthetic protocol (intervention arm)
Sites / Locations
- Johns Hopkins HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Standardized Protocol
Provider Choice Protocol
Arm Description
Premed Acetaminophen PO 15mg/kg Scopolamine patch + PO/IV Midazolam as needed Induction Lidocaine (1.5 mg/kg), propofol (1-3 mg/kg), and rocuronium (0.6mg/kg) Fentanyl 100 mcg bolus Dexmedetomidine 0.3 mcg/kg bolus Nasotracheal intubation (NTI) Dexamethasone 4-8mg q4-6 hours Tranexamic acid 30mg/kg bolus Ancef 30 mg/kg bolus Room Bolus line 4 Channel/pump infusion line w/: Maintenance IVFs/Carrier, Dexmedetomidine, TXA, Precedex or Phenylephrine Maintenance Sevo/isoflurane at 0.5-0.7 MAC with rocuronium boluses as needed Dexmedetomidine 0.3- 0.5 mcg/kg/hour Fentanyl 50 mcg boluses TXA 15 mg/kg/hr Phenylephrine 0.2-1 mcg/kg/min as needed Emergence Stop dexmedetomidine before emergence Re-dose acetaminophen 15 mg/kg IV Toradol 0.5 mg/kg Zofran 0.15 mg/kg Reverse with sugammadex OGT placement, extubate awake
Patients will be managed with provider-specific protocols, which may vary.
Outcomes
Primary Outcome Measures
Postoperative pain
The degree (as ranked on a scale from 1-10) and duration of postoperative pain, including necessity of postoperative analgesia
Secondary Outcome Measures
Length of stay
Length of inpatient stay (in days)
Critical care utilization
Utilization, and, where appropriate, length of use of the following: ICU, ventilatory support, intubation
Full Information
NCT ID
NCT05260320
First Posted
February 2, 2022
Last Updated
October 5, 2023
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT05260320
Brief Title
Anesthetic Optimization in Pediatric LeFort Surgeries
Official Title
Anesthetic Optimization in Pediatric LeFort Surgeries
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will propose and evaluate a standardized LeFort osteotomy anesthetic protocol for pediatric patients at Johns Hopkins Hospital via a randomized controlled trial. 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 via a randomized controlled trial. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Le Fort, Pain, Postoperative
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized to one of two study arms: intervention (standardized protocol) or control (no standardized protocol)
Masking
ParticipantOutcomes Assessor
Masking Description
The investigator, surgeon, and anesthesiologists will be aware of study arm (in order to properly implement the intervention). The patient and postoperative care teams (who will asses for postoperative pain and necessity of additional interventions) will be blinded.
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standardized Protocol
Arm Type
Experimental
Arm Description
Premed
Acetaminophen PO 15mg/kg
Scopolamine patch + PO/IV Midazolam as needed
Induction
Lidocaine (1.5 mg/kg), propofol (1-3 mg/kg), and rocuronium (0.6mg/kg)
Fentanyl 100 mcg bolus
Dexmedetomidine 0.3 mcg/kg bolus
Nasotracheal intubation (NTI)
Dexamethasone 4-8mg q4-6 hours
Tranexamic acid 30mg/kg bolus
Ancef 30 mg/kg bolus
Room
Bolus line
4 Channel/pump infusion line w/: Maintenance IVFs/Carrier, Dexmedetomidine, TXA, Precedex or Phenylephrine
Maintenance
Sevo/isoflurane at 0.5-0.7 MAC with rocuronium boluses as needed
Dexmedetomidine 0.3- 0.5 mcg/kg/hour
Fentanyl 50 mcg boluses
TXA 15 mg/kg/hr
Phenylephrine 0.2-1 mcg/kg/min as needed
Emergence
Stop dexmedetomidine before emergence
Re-dose acetaminophen 15 mg/kg IV
Toradol 0.5 mg/kg
Zofran 0.15 mg/kg
Reverse with sugammadex
OGT placement, extubate awake
Arm Title
Provider Choice Protocol
Arm Type
No Intervention
Arm Description
Patients will be managed with provider-specific protocols, which may vary.
Intervention Type
Other
Intervention Name(s)
Standardized Anesthetic Course from Premedication to Induction
Intervention Description
See information in intervention group description
Primary Outcome Measure Information:
Title
Postoperative pain
Description
The degree (as ranked on a scale from 1-10) and duration of postoperative pain, including necessity of postoperative analgesia
Time Frame
From hospital admission (on day of surgery) to discharge, which is expected to last 2-7 days though may be up to 30 days
Secondary Outcome Measure Information:
Title
Length of stay
Description
Length of inpatient stay (in days)
Time Frame
From hospital admission (on day of surgery) to discharge, which is expected to last 2-7 days though may be up to 30 days
Title
Critical care utilization
Description
Utilization, and, where appropriate, length of use of the following: ICU, ventilatory support, intubation
Time Frame
From hospital admission (on day of surgery) to discharge, which is expected to last 2-7 days though may be up to 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Undergoing Le Fort osteotomy at Johns Hopkins Hospital
Age >= 14 years
Exclusion Criteria:
Contraindications to standardized anesthetic protocol (intervention arm)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robin Yang, MD, DDS
Phone
443-997-9466
Email
ryang14@jhmi.edu
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robin Yang, MD, DDS
Phone
443-997-9466
Email
ryang14@jhmi.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD will be shared with those conducting research data collection and analysis, and IPD that underlie results in a publication will be published.
IPD Sharing Time Frame
Data will become available to the study team upon collection and will be deleted after publication
IPD Sharing Access Criteria
IPD access will be granted to those researchers making significant contributions to data collection or analysis, at the discretion of the principal investigator
Citations:
PubMed Identifier
13376109
Citation
SADOVE MS. Anesthetic management for maxillofacial surgery. Ill Med J. 1956 Nov;110(5):227-31. No abstract available.
Results Reference
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PubMed Identifier
34046286
Citation
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.
Results Reference
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PubMed Identifier
31073483
Citation
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.
Results Reference
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PubMed Identifier
31645264
Citation
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.
Results Reference
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PubMed Identifier
32346234
Citation
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.
Results Reference
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PubMed Identifier
14704568
Citation
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.
Results Reference
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PubMed Identifier
26303951
Citation
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.
Results Reference
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PubMed Identifier
29446987
Citation
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.
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Citation
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.
Results Reference
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Anesthetic Optimization in Pediatric LeFort Surgeries
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