Assessment of Hematologic Parameters Before and After Bimaxillary Orthognathic Surgery

NCT ID: NCT02364765

Last Updated: 2015-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-06-30

Brief Summary

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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

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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.

Conditions

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Surgical Blood Loss

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Orthognatic surgery

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.

Group Type OTHER

Remifentanil

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Ultiva

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Federal University of Minas Gerais

OTHER

Sponsor Role lead

Responsible Party

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Antônio Luís Neto Custódio

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antônio LN Custódio, DDS MSc PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Morphology, Institute of Biological Sciences, Federal University of Minas Gerais

Locations

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Department of Oral and Maxillofacial Surgery - Baleia Hospital

Belo Horizonte, Minas Gerais, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 26280080 (View on PubMed)

Other Identifiers

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0267.0.203.000-10

Identifier Type: -

Identifier Source: org_study_id

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