Surgical Blood LossNCT02364765

Assessment of Hematologic Parameters Before and After Bimaxillary Orthognathic Surgery

A study testing Remifentanil in people with Surgical Blood Loss, run by Federal University of Minas Gerais at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Surgical Blood Loss
What is being tested?: Remifentanil
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 1 siteBrazil
Study dates: Aug 2010to Jun 2012
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Department of Oral and Maxillofacial Surgery - Baleia Hospital
Belo Horizonte, Minas Gerais, 30285-000

Other trials in Brazil

About this study

Official title: Assessment of Changes of Hematological Parameters and Need for Blood Transfusion in 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.

Read the 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.

Conditions: Surgical Blood Loss
Being tested: Remifentanil
Keywords: Maxillofacial Orthognathic Surgery, Hemoglobin, Red Blood Cells, Hematocrit, Blood Platelets, Body Weight, Operative Time, Age Groups, Gender
Medical subject headings: Blood Loss, Surgical, Body Weight, Coitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RemifentanilDrug
Also called Ultiva
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

Study groups in NCT02364765
Study group	Role	What they receive
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. Receives: Drug: Remifentanil

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2010Jun 2012

First posted18 Feb 2015 (estimated)
Study startAug 2010
Primary completionJun 2012
Study completionJun 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Surgical Blood LossStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02364765
Sponsor's protocol ID: 0267.0.203.000-10
Status last verified: Feb 2015
First submitted: 4 Feb 2015
Last updated: 18 Feb 2015
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 26280080

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Surgical Blood Loss trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Changes of Hematological Parameters and Need for Blood Transfusion in Bimaxillary Orthognathic Surgery
ClinicalTrials.gov ID: NCT02364765
Acronym / sponsor ID: 0267.0.203.000-10
Conditions: Surgical Blood Loss
Keywords: Maxillofacial Orthognathic Surgery, Hemoglobin, Red Blood Cells, Hematocrit, Blood Platelets, Body Weight, Operative Time, Age Groups
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: Federal University of Minas GeraisUniversity, hospital or other
Study start: Aug 2010
Primary completion: Jun 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 18 Feb 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Orthognatic surgery	Other	Drug: RemifentanilElective 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RemifentanilAlso: UltivaElective 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	Orthognatic surgery

Primary outcome

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)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2015.
Derived from this study: PubMed 26280080Chrcanovic 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.

Related trials for Surgical Blood Loss

Not yet recruitingObservational study
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Cardiac Surgical Procedures, Blood Transfusion
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Cardiac Surgery, Cardiopulmonary Bypass
Recruiting
Prospective, Multicenter, Randomized Controlled Phase III Trial of Biological Mesh for Alimentary Tract Reconstruction in Digestive Surgery
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Antônio LN Custódio, DDS MSc PhD principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Remifentanil in people with Surgical Blood Loss, run by Federal University of Minas Gerais at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in hematologic parameters (time frame: From immediately before the surgery until 24 h after operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02364765, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2015.