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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02364765
Other study ID # 0267.0.203.000-10
Secondary ID
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


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
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