CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 180 enrolled
Drug / intervention
Methylprednisolonedrug
Likely dose
Methylprednisolone 1000mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03190642
NCT03190642Phase 4Completed

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

Jean Charles Doucet·interventional·Posted Jun 19, 2017·Updated Aug 3, 2021

In Brief

A Phase 4 clinical trial evaluating Methylprednisolone for Post-operative Edema and Steroid Use. Completed, enrolled 180 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedJun 19, 2017
Enrollment StartJan 1, 2018
Primary CompletionJul 1, 2019
Study CompletionDec 31, 2019
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 9.0 years ago

Interventions

Methylprednisolonedrug

Administration of 1000mg vs 125mg methylprednisolone preoperatively in orthognathic surgery.