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Assessment 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
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
February 4, 2015
Last Updated
February 10, 2015
Sponsor
Federal University of Minas Gerais
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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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