Surgical ProceduresNCT01130610
Pre-anesthetic Evaluation and Cost Reduction
An observational study of Surgical Procedures and Anesthesia, run by Santa Casa de Misericórdia de Belo Horizonte at 1 site in Brazil.
Trial summary
Study conducted in large Brazilian hospital, with the main objective of evaluating the impact of pre-anesthetic in reducing costs related to the preoperative preparation of patients admitted to undergo surgery or diagnostic procedures under anesthesia. Read more about this study
- Who is it for?
- Ages 1 year to 90 years
- Conditions the study is for
- Surgical Procedures, Anesthesia
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2009to Nov 2009
- Phase
- Observational
- 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 1 year to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients admitted to the institution to undergo elective surgery or diagnostic procedures with anesthesia.
Who may be able to join
- patients over the age of one year and admitted for surgery or diagnostic procedures under anesthesia
- patient did not undergo pre-anesthetic evaluation prior to admission to hospital
Who cannot join
- Emergency surgery
- Major surgery with hospitalization on a date prior to the operation
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte, Minas Gerais, 30150-221
About this study
Official title: Pre-anesthetic Evaluation and Cost Reduction Perioperative
Study conducted in large Brazilian hospital, with the main objective of evaluating the impact of pre-anesthetic in reducing costs related to the preoperative preparation of patients admitted to undergo surgery or diagnostic procedures under anesthesia.
Read the detailed description
The pre-anesthetic evaluation is essential in the care of surgical patients. Among its benefits stands the reduction of costs related to preoperative preparation. However, most studies evaluating costs was performed in hospitals abroad, whose reality does not always apply to our environment. The aim of this study is to compare the costs of preoperative evaluation performed by the surgeon (conventional tillage), with the cost of preparation performed by the anesthesiologist (pre-anesthetic evaluation). Two hundred patients scheduled for surgical or diagnostic procedures under anesthesia form included in the study. After admission patients were assessed by physician anesthesiologists. In Form 1 (conventional tillage), it was noted tests or specialist consultations made in the preoperative period. In Form 2 (pre-anesthetic evaluation) was noted comorbidities, physical examination and complementary examinations given in accordance with the guidelines adopted by the Anesthesiology Department of the institution. Form data were compared with a data form 2. Besides the costs, we compared the number of tests considered unnecessary and disagreements in the classification of physical status according to the American Society Anesthesiology (ASA).
- Conditions
- Surgical Procedures, Anesthesia
- Keywords
- preoperative period, preoperative care, anesthesia, program evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2010 (estimated)
- Study startSep 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Surgical ProceduresStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santa Casa de Misericórdia de Belo Horizonte
- Sponsor type
- University, hospital or other
- Investigators
- Issa Márcia, graduate, Study director, Santa Casa de Misericórdia de Belo HorizonteMagda Fernandes, Master, Principal investigator, Santa Casa de Misericórdia de Belo Horizonte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01130610
- Sponsor's protocol ID
- CEP 089/2009
- Status last verified
- May 2010
- First submitted
- 24 May 2010
- Last updated
- 26 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Power LM, Thackray NM. Reduction of preoperative investigations with the introduction of an anaesthetist-led preoperative assessment clinic. Anaesth Intensive Care. 1999 Oct;27(5):481-8. doi: 10.1177/0310057X9902700508.
PubMed 10520388Fischer SP. Development and effectiveness of an anesthesia preoperative evaluation clinic in a teaching hospital. Anesthesiology. 1996 Jul;85(1):196-206. doi: 10.1097/00000542-199607000-00025. No abstract available.
PubMed 8694365Pasternak LR. Preoperative laboratory testing: general issues and considerations. Anesthesiol Clin North Am. 2004 Mar;22(1):13-25. doi: 10.1016/S0889-8537(03)00115-9.
PubMed 15109688
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-anesthetic Evaluation and Cost Reduction Perioperative
- ClinicalTrials.gov ID
- NCT01130610
- Acronym / sponsor ID
- CEP 089/2009
- Conditions
- Surgical Procedures, Anesthesia
- Keywords
- preoperative period, preoperative care, anesthesia, program evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Santa Casa de Misericórdia de Belo HorizonteUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 26 May 2010 (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.
Study conducted in large Brazilian hospital, with the main objective of evaluating the impact of pre-anesthetic in reducing costs related to the preoperative preparation of patients admitted to undergo surgery or diagnostic procedures under anesthesia.
Detailed description
The pre-anesthetic evaluation is essential in the care of surgical patients. Among its benefits stands the reduction of costs related to preoperative preparation. However, most studies evaluating costs was performed in hospitals abroad, whose reality does not always apply to our environment. The aim of this study is to compare the costs of preoperative evaluation performed by the surgeon (conventional tillage), with the cost of preparation performed by the anesthesiologist (pre-anesthetic evaluation). Two hundred patients scheduled for surgical or diagnostic procedures under anesthesia form included in the study. After admission patients were assessed by physician anesthesiologists. In Form 1 (conventional tillage), it was noted tests or specialist consultations made in the preoperative period. In Form 2 (pre-anesthetic evaluation) was noted comorbidities, physical examination and complementary examinations given in accordance with the guidelines adopted by the Anesthesiology Department of the institution. Form data were compared with a data form 2. Besides the costs, we compared the number of tests considered unnecessary and disagreements in the classification of physical status according to the American Society Anesthesiology (ASA).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients admitted to the institution to undergo elective surgery or diagnostic procedures with anesthesia.
Key inclusion criteria (2 listed)
- patients over the age of one year and admitted for surgery or diagnostic procedures under anesthesia
- patient did not undergo pre-anesthetic evaluation prior to admission to hospital
Key exclusion criteria (2 listed)
- Emergency surgery
- Major surgery with hospitalization on a date prior to the operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 26 May 2010.
- Results publication: PubMed 10520388Power LM, Thackray NM. Reduction of preoperative investigations with the introduction of an anaesthetist-led preoperative assessment clinic. Anaesth Intensive Care. 1999 Oct;27(5):481-8. doi: 10.1177/0310057X9902700508.
- Results publication: PubMed 8694365Fischer SP. Development and effectiveness of an anesthesia preoperative evaluation clinic in a teaching hospital. Anesthesiology. 1996 Jul;85(1):196-206. doi: 10.1097/00000542-199607000-00025. No abstract available.
- Results publication: PubMed 15109688Pasternak LR. Preoperative laboratory testing: general issues and considerations. Anesthesiol Clin North Am. 2004 Mar;22(1):13-25. doi: 10.1016/S0889-8537(03)00115-9.
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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.
Issa Márcia, graduate study director
Santa Casa de Misericórdia de Belo Horizonte
Magda Fernandes, Master principal investigator
Santa Casa de Misericórdia de Belo Horizonte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Procedures and Anesthesia, run by Santa Casa de Misericórdia de Belo Horizonte 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 2 inclusion and 2 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 26 May 2010. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01130610, which also lists 3 linked publications.
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 26 May 2010.