Prospective Evaluation of Perioperative Steroid Dosing on Postsurgical Edema in Orthognathic Surgery

• Status: Completed
• Trial end date: 2019-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The current standard of care at the Oral and Maxillofacial Department at the CDHA is the use of one gram of methylprednisolone administered intravenously prior to orthognathic surgery. This is largely based on the work of Habal. The administration of one gram of methylprednisolone can be concerning for the anesthesiologist since this is an unusually large dose of steroid in comparison to use in other surgical specialties. As with most medications, the chances of steroid-related complications increase with increasing doses of steroids.

The researchers are proposing a prospective, double-blind randomized control trial to determine if a smaller dose of methylprednisolone (125mg) can be used safely and effectively instead of one gram of methylprednisolone.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Jean Charles Doucet
• Collaborator: Nova Scotia Health Authority
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• All patients age 14 and over undergoing orthognathic surgery at the Atlantic Centre of Oral and Maxillofacial Surgery in Halifax, Nova Scotia will be included in our study. The clinic is located in the Victoria General Hospital in Halifax, Nova Scotia. Orthognathic surgery includes any combination of Lefort 1, Bilateral Sagittal Split Osteotomy (BSSO) and functional genioplasty procedures.

Exclusion Criteria:

• Patients with pertinent medical history that precludes the use of high-dose steroids will be excluded from our study. This includes:

• Known hypersensitivity to steroids

• Type 1 diabetic patients who may have a severe elevation of blood sugars with steroid use.

• Systemic fungal infections

• Arrested tuberculosis

• Herpes simplex keratitis

• Acute psychoses

• Cushing's syndrome

• Peptic ulcer disease

• Pregnant patients and patients with current infections will be excluded Breast feeding mother