Back to resultsAssessment of Hematologic Parameters Before and After Bimaxillary Orthognathic Surgery
Primary Purpose
Surgical Blood Loss
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Remifentanil
Sponsored by
About this trial
This is an interventional treatment trial for Surgical Blood Loss focused on measuring Maxillofacial Orthognathic Surgery, Hemoglobin, Red Blood Cells, Hematocrit, Blood Platelets, Body Weight, Operative Time, Age Groups, Gender
Eligibility Criteria
Inclusion Criteria:
- All consecutive patients listed for elective bimaxillary osteotomies for orthognathic correction by one surgical team, and admitted from August 2010 until June 2012.
Exclusion Criteria:
- Patients who were having single maxillary osteotomies, Le Fort II and III osteotomies, those with general contraindications for extensive surgical intervention, syndromic patients, those with cleft palate, and those with general diseases or hematological disorders.
Sites / Locations
- Department of Oral and Maxillofacial Surgery - Baleia Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Orthognatic surgery
Arm Description
Elective bimaxillary orthognathic surgery consisting of a unsegmented LeFort I osteotomy combined with a bilateral sagittal split osteotomy, under the influence of mean remifentanil administration of 0.3 mg/kg/hour.
Outcomes
Primary Outcome Measures
Change in hematologic parameters
Hemoglobin (g/dL), red blood cells (cells/mcL), hematocrit (volume %), platelet (cells/mcL)
Secondary Outcome Measures
Full Information
NCT ID
NCT02364765
First Posted
February 4, 2015
Last Updated
February 10, 2015
Sponsor
Federal University of Minas Gerais
1. Study Identification
Unique Protocol Identification Number
NCT02364765
Brief Title
Assessment of Hematologic Parameters Before and After Bimaxillary Orthognathic Surgery
Official Title
Assessment of Changes of Hematological Parameters and Need for Blood Transfusion in Bimaxillary Orthognathic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the present study was to compare some hematologic parameters and operation time in patients who underwent esthetic bimaxillary surgery under hypotensive anesthesia.
Detailed Description
Patients who underwent bimaxillary surgery were prospectively evaluated. Patients were divided into groups based on the surgical procedure and sex (predictor variables). Hemoglobin, red blood cells, hematocrit, and platelet were the primary outcome variables, operation time was the secondary outcome variable, and the patients' age and weight were the other variables.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Blood Loss
Keywords
Maxillofacial Orthognathic Surgery, Hemoglobin, Red Blood Cells, Hematocrit, Blood Platelets, Body Weight, Operative Time, Age Groups, Gender
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Orthognatic surgery
Arm Type
Other
Arm Description
Elective bimaxillary orthognathic surgery consisting of a unsegmented LeFort I osteotomy combined with a bilateral sagittal split osteotomy, under the influence of mean remifentanil administration of 0.3 mg/kg/hour.
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Other Intervention Name(s)
Ultiva
Intervention Description
Elective bimaxillary orthognathic surgery consisting of a unsegmented LeFort I osteotomy combined with a bilateral sagittal split osteotomy, under the influence of mean remifentanil administration of 0.3 mg/kg/hour
Primary Outcome Measure Information:
Title
Change in hematologic parameters
Description
Hemoglobin (g/dL), red blood cells (cells/mcL), hematocrit (volume %), platelet (cells/mcL)
Time Frame
From immediately before the surgery until 24 h after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All consecutive patients listed for elective bimaxillary osteotomies for orthognathic correction by one surgical team, and admitted from August 2010 until June 2012.
Exclusion Criteria:
Patients who were having single maxillary osteotomies, Le Fort II and III osteotomies, those with general contraindications for extensive surgical intervention, syndromic patients, those with cleft palate, and those with general diseases or hematological disorders.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antônio LN Custódio, DDS MSc PhD
Organizational Affiliation
Department of Morphology, Institute of Biological Sciences, Federal University of Minas Gerais
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Oral and Maxillofacial Surgery - Baleia Hospital
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30285-000
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
26280080
Citation
Chrcanovic BR, Toledo GL, Amaral MB, Custodio AL. Assessment of hematologic parameters before and after bimaxillary orthognathic surgery. Oral Maxillofac Surg. 2016 Mar;20(1):35-43. doi: 10.1007/s10006-015-0525-2. Epub 2015 Aug 18.
Results Reference
derived
Learn more about this trial
Assessment of Hematologic Parameters Before and After Bimaxillary Orthognathic Surgery
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