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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03190642
Recruitment Status : Recruiting
First Posted : June 19, 2017
Last Update Posted : June 21, 2018
Sponsor:
Collaborator:
Nova Scotia Health Authority
Information provided by (Responsible Party):
Jean Charles Doucet, Nova Scotia Health Authority

Brief 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.


Condition or disease Intervention/treatment Phase
Post-operative Edema Steroid Use Drug: Methylprednisolone Phase 4

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Prospective Evaluation of Perioperative Steroid Dosing on Postsurgical Edema in Orthognathic Surgery
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : December 31, 2019


Arm Intervention/treatment
Active Comparator: 1000mg methylprednisolone group
Evaluating effects of 1000mg of methylpresdnisolone administered immediately preoperatively and its effects on swelling.
Drug: Methylprednisolone
Administration of 1000mg vs 125mg methylprednisolone preoperatively in orthognathic surgery.
Other Name: Solumedrol

Active Comparator: 125mg methylprednisolone group
Evaluating effects of 125mg of methylpresdnisolone administered immediately preoperatively and its effects on swelling.
Drug: Methylprednisolone
Administration of 1000mg vs 125mg methylprednisolone preoperatively in orthognathic surgery.
Other Name: Solumedrol




Primary Outcome Measures :
  1. Post-operative edema [ Time Frame: Post-operative period- post-op day 1 until braces off or until 100 weeks post-operatively, whichever comes first ]
    Measurement of post-operative edema using 3D facial scanner


Secondary Outcome Measures :
  1. Patient perceived swelling [ Time Frame: Post-operative day 2 ]
    Measurement of post-operative patient perceived swelling via survey

  2. Post-operative pain [ Time Frame: Post-operative day 2 ]
    Measurement of post-operative pain via survey

  3. Post-operative sleep [ Time Frame: Post-operative day 2 ]
    Measurement of post-operative sleep via survey

  4. Post-operative nausea [ Time Frame: Post-operative day 2 ]
    Measurement of post-operative nausea via survey

  5. Length of hospital stay [ Time Frame: Until discharge from hospital or post-operative day 100, which ever comes first ]
    Measurement of length of post-operative hospital stay

  6. Rate of post-operative infection [ Time Frame: Post-operative period- post-op day 1 until braces off or until 100 weeks post-operatively, which ever comes first ]
    Measurement of post-operative infections



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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03190642


Contacts
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Contact: Matthew B Fay, DDS, BSc 902-473-2070 mfay@ualberta.ca
Contact: Jean-Charles Doucet, DMD, MSc, MD 902-473-2070 jc.doucet@dal.ca

Locations
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Canada, Nova Scotia
QE II Health Sciences Center Recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Contact: Jean-Charles Doucet, DDS, MD    902-473-2070    jcdoucet@gmail.com   
Contact: Matthew Fay, BSc, DDS    902-473-2070    mfay@ualberta.ca   
Sponsors and Collaborators
Jean Charles Doucet
Nova Scotia Health Authority

Publications:

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Responsible Party: Jean Charles Doucet, Principal Investigator, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT03190642    
Other Study ID Numbers: OMFSTEROIDS
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: NO IPD will be shared with researchers outside of the study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jean Charles Doucet, Nova Scotia Health Authority:
Orthognathic Surgery
Swelling
Additional relevant MeSH terms:
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Edema
Signs and Symptoms
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents