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Completed

NCT Number: NCT02364765

Assessment of Hematologic Parameters Before and After Bimaxillary Orthognathic Surgery

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.

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Key information

Conditions

Surgical Blood Loss Behavior Blood Loss, Surgical Body Weight Coitus Hemorrhage Intraoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Sexual Behavior Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Oral and Maxillofacial Surgery - Baleia Hospital

Belo Horizonte, Minas Gerais, 30285-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remifentanil

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

Other names: Ultiva

Primary outcomes

  1. Change in hematologic parameters

    Time frame: From immediately before the surgery until 24 h after operation

    Hemoglobin (g/dL), red blood cells (cells/mcL), hematocrit (volume %), platelet (cells/mcL)

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 18, 2015
Registry last updated
Feb 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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