Assessment of Hematologic Parameters Before and After Bimaxillary Orthognathic Surgery

Surgical Blood Loss Clinical Trial

Official title:

Assessment of Changes of Hematological Parameters and Need for Blood Transfusion in Bimaxillary Orthognathic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02364765
• Other study ID #: 0267.0.203.000-10
• Status: Completed
• Phase: N/A
• First received: February 4, 2015
• Last updated: February 10, 2015
• Start date: August 2010
• Est. completion date: June 2012

Study information

• Verified date: February 2015
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Surgical Blood Loss

Intervention

Drug:
• Remifentanil
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

Locations

Country	Name	City	State
Brazil	Department of Oral and Maxillofacial Surgery - Baleia Hospital	Belo Horizonte	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hematologic parameters	Hemoglobin (g/dL), red blood cells (cells/mcL), hematocrit (volume %), platelet (cells/mcL)	From immediately before the surgery until 24 h after operation	No