Assessment of Hematologic Parameters Before and After Bimaxillary Orthognathic Surgery

NCT02364765 | Completed

• 1 other identifier: 0267.0.203.000-10
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Blood Loss

Keywords

Maxillofacial Orthognathic Surgery; Hemoglobin; Red Blood Cells; Hematocrit; Blood Platelets; Body Weight; Operative Time; Age Groups; Gender

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Orthognatic surgery

OTHER

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.

Drug: Remifentanil

Interventions

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

Also known as: Ultiva

Orthognatic surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All consecutive patients listed for elective bimaxillary osteotomies for orthognathic correction by one surgical team, and admitted from August 2010 until June 2012.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (1)

Department of Oral and Maxillofacial Surgery - Baleia Hospital

Belo Horizonte, Minas Gerais, 30285-000, Brazil

Location

Related Publications (1)

• 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.

  PMID: 26280080 DERIVED

MeSH Terms

Conditions

Blood Loss, Surgical; Body Weight; Coitus

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications; Signs and Symptoms; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Antônio LN Custódio, DDS MSc PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 4, 2015
• First Posted: February 18, 2015
• Study Start: August 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: February 18, 2015

Record last verified: 2015-02

Locations

BR (1)