Anesthetic Optimization in Pediatric LeFort Surgeries

Sponsor
Johns Hopkins University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05260320
Collaborator
(none)
50
1
2
24
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Standardized Anesthetic Course from Premedication to Induction
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patients will be randomized to one of two study arms: intervention (standardized protocol) or control (no standardized protocol)Patients will be randomized to one of two study arms: intervention (standardized protocol) or control (no standardized protocol)
Masking:
Double (Participant, Outcomes 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.
Primary Purpose:
Prevention
Official Title:
Anesthetic Optimization in Pediatric LeFort Surgeries
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Standardized Protocol

Patients will have the following operative anesthetic course: Premed Acetaminophen PO 15mg/kg Scopolamine patch + PO/IV Midazolam as needed Induction Standard: lidocaine (1.5 mg/kg), propofol (1-3 mg/kg), rocuronium (0.6mg/kg) Sufentanil 1 mcg/kg bolus Nasotracheal intubation Dexamethasone 4-8mg q4-6 hours Tranexamic acid (TXA) 30mg/kg bolus Ancef 30 mg/kg bolus Room Bolus line 4 Channel/pump infusion line with: Maintenance IVFs/Carrier, Sufentantil, TXA, Precedex or Phenylephrine Maintenance Sevo/isoflurane at 0.5-0.7 MAC with rocuronium boluses as needed Sufenantil 0.3 mcg/kg/hr, titrate as needed TXA 15 mg/kg/hr Phenylephrine 0.2-1 mcg/kg/min as needed Emergence Stop sufentanil 1 hr before closing, start dexmedetomidine 0.5 mcg/kg/hr Re-dose acetaminophen 15 mg/kg IV Toradol 0.5 mg/kg Zofran 0.15 mg/kg Reverse with sugammadex OGT placement, extubate awake

Other: Standardized Anesthetic Course from Premedication to Induction
See information in intervention group description

No Intervention: Provider Choice Protocol

Patients will be managed with provider-specific protocols, which may vary.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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)

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Undergoing Le Fort osteotomy at Johns Hopkins Hospital

  • Age >= 14 years

Exclusion Criteria:
  • Contraindications to standardized anesthetic protocol (intervention arm)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Johns Hopkins Hospital Baltimore Maryland United States 21287

Sponsors and Collaborators

  • Johns Hopkins University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT05260320
Other Study ID Numbers:
  • IRB00316335
First Posted:
Mar 2, 2022
Last Update Posted:
Aug 18, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 18, 2022