Assessment of Hematologic Parameters Before and After Bimaxillary Orthognathic Surgery

Not Applicable

Completed

• Conditions: Surgical Blood Loss
• Interventions: Drug: Remifentanil

• Registration Number: NCT02364765
• Lead Sponsor: Federal University of Minas Gerais

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.

Detailed 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.

Study Timeline

• Study Start: 2010-08
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2015-02
• Study First Submitted: 2015-02-04
• Study First Submitted QC: 2015-02-10
• Last Update Submitted: 2015-02-10
• Study First Posted: 2015-02-18
• Last Update Posted: 2015-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Orthognatic surgery	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.

Primary Outcome Measures

Name	Time	Method
Change in hematologic parameters	From immediately before the surgery until 24 h after operation	Hemoglobin (g/dL), red blood cells (cells/mcL), hematocrit (volume %), platelet (cells/mcL)

Trial Locations

Locations (1)

Department of Oral and Maxillofacial Surgery - Baleia Hospital; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil