AnesthesiaNCT02820922
Anesthesia for Emergency Orthopedic Surgery
An observational study of Anesthesia, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this retrospective study is to evaluate the preferred anaesthesia techniques in our clinic for emergency orthopedic surgery at a 1 year period. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anesthesia
- What is being tested?
- Orthopedic
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2016to Jun 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients of all age groups who administered for orthopedic emergency surgery
Who may be able to join
- all patients who had orthopedic emergency surgery
Who cannot join
- involvement of incomplete data collection
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sakarya University Research and Training Hospital
Sakarya, 54100
Havva Sayhan, assist prof, +905056621021, hsayhan@gmail.com
Ali F Erdem, prof, +90 264 8884051, alifuaterdem@gmail.com
About this study
Official title: Anesthetic Techniques for Emergency Orthopedic Surgery
The aim of this retrospective study is to evaluate the preferred anaesthesia techniques in our clinic for emergency orthopedic surgery at a 1 year period.
Read the detailed description
This retrospective study included patients of all ages who have undergone emergency orthopedic surgery between January 2015 and December 2015 after approval of the research ethics committee. Medical record forms and electronic medical record system of the hospital were used in the analysis of medical data with regard to age, sex, ASA score, anaesthesia technique, comorbidities, surgery diagnosis, length of surgery, complications and admission to intensive care unit after surgery.
- Conditions
- Anesthesia
- Being tested
- Orthopedic
- Keywords
- Emergency orthopedic surgery, anesthesia, general anesthesia, regional anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrthopedicProcedure or surgery
Also called regional anesthesia, sedation, general anesthesia
anesthesia techniques with regard to age, sex, ASA score, anaesthesia technique, comorbidities, surgery diagnosis, length of surgery, complications and admission to intensive care unit after surgery
| Study group | Role | What they receive |
|---|---|---|
| Orthopedic emergency surgery | Patients of all ages who have undergone emergency orthopedic surgery The analysis of medical data with regard to age, sex, the American Society of Anesthesiologists (ASA) score, anaesthesia technique, comorbidities, surgery diagnosis, length of surgery, complications and admission to intensive care unit after surgery Receives: Procedure: Orthopedic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with preferred anesthesia technique for orthopedic emergency surgery assessed by Statistical Package for the Social Sciences (SPSS) v22.0
Statistical assessment would be carried out with regard to anesthesia technique. Outcome measures the number of patients with demographic data arrive at orthopedic emergency service. Results will be helpful on preferred anesthesia technique at orthopedic emergency surgery in our clinic.
Measured: 1 year
Secondary outcomes (2)
Assessment of ages and anesthesia technique relation on orthopedic emergency surgery by SPSS v22.0
Age is a factor that make changes relevant to anesthesia. The study analyze the influence of age on anesthesia technique at orthopedic emergency surgery.
Measured: 3 months
Assessment of orthopedic surgery type and anesthesia relation on orthopedic emergency surgery by SPSS v22.0
Statistical evaluation of orthopedic surgery type relevant to anesthesia. The study analyze the influence of surgery type on preferred anesthesia technique at our hospital.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startMar 2016
- Primary completionFeb 2017 (estimated)
- Study completionJun 2017 (estimated)
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 AnesthesiaStudies 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
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Havva Sayhan, Sakarya University
- Investigators
- Ali F Erdem, Prof, Study chair, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820922
- Sponsor's protocol ID
- Sakarya University
- Status last verified
- Jun 2016
- First submitted
- 24 Jun 2016
- Last updated
- 1 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Clark L, Robinson M, Varbanova M. Role of regional anesthesia in orthopedic trauma. Anesthesiol Clin. 2014 Dec;32(4):789-808. doi: 10.1016/j.anclin.2014.08.002. Epub 2014 Nov 25.
PubMed 25453662Stundner O, Ortmaier R, Memtsoudis SG. Which outcomes related to regional anesthesia are most important for orthopedic surgery patients? Anesthesiol Clin. 2014 Dec;32(4):809-21. doi: 10.1016/j.anclin.2014.08.003. Epub 2014 Nov 25.
PubMed 25453663Campbell VL. Anesthetic protocols for common emergencies. Vet Clin North Am Small Anim Pract. 2005 Mar;35(2):435-53. doi: 10.1016/j.cvsm.2004.10.005.
PubMed 15698919
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthetic Techniques for Emergency Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT02820922
- Acronym / sponsor ID
- Sakarya University
- Conditions
- Anesthesia
- Keywords
- Emergency orthopedic surgery, anesthesia, general anesthesia, regional anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 1 Jul 2016 (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 aim of this retrospective study is to evaluate the preferred anaesthesia techniques in our clinic for emergency orthopedic surgery at a 1 year period.
Detailed description
This retrospective study included patients of all ages who have undergone emergency orthopedic surgery between January 2015 and December 2015 after approval of the research ethics committee. Medical record forms and electronic medical record system of the hospital were used in the analysis of medical data with regard to age, sex, ASA score, anaesthesia technique, comorbidities, surgery diagnosis, length of surgery, complications and admission to intensive care unit after surgery.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orthopedic emergency surgery | – | Procedure: OrthopedicPatients of all ages who have undergone emergency orthopedic surgery The analysis of medical data with regard to age, sex, the American Society of Anesthesiologists (ASA) score, anaesthesia technique, comorbidities, surgery diagnosis, length of surgery, complications and admission to intensive care unit after surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of all age groups who administered for orthopedic emergency surgery
Key inclusion criteria (1 listed)
- all patients who had orthopedic emergency surgery
Key exclusion criteria (1 listed)
- involvement of incomplete data collection
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 |
|---|---|---|
| OrthopedicAlso: regional anesthesia, sedation, general anesthesiaanesthesia techniques with regard to age, sex, ASA score, anaesthesia technique, comorbidities, surgery diagnosis, length of surgery, complications and admission to intensive care unit after surgery | Procedure or surgery | Orthopedic emergency surgery |
Primary outcome
Number of patients with preferred anesthesia technique for orthopedic emergency surgery assessed by Statistical Package for the Social Sciences (SPSS) v22.0
Time frame: 1 year
Statistical assessment would be carried out with regard to anesthesia technique. Outcome measures the number of patients with demographic data arrive at orthopedic emergency service. Results will be helpful on preferred anesthesia technique at orthopedic emergency surgery in our clinic.
2 secondary outcomes
Assessment of ages and anesthesia technique relation on orthopedic emergency surgery by SPSS v22.0
Time frame: 3 months
Assessment of orthopedic surgery type and anesthesia relation on orthopedic emergency surgery by SPSS v22.0
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2016.
- Background: PubMed 25453662Clark L, Robinson M, Varbanova M. Role of regional anesthesia in orthopedic trauma. Anesthesiol Clin. 2014 Dec;32(4):789-808. doi: 10.1016/j.anclin.2014.08.002. Epub 2014 Nov 25.
- Background: PubMed 25453663Stundner O, Ortmaier R, Memtsoudis SG. Which outcomes related to regional anesthesia are most important for orthopedic surgery patients? Anesthesiol Clin. 2014 Dec;32(4):809-21. doi: 10.1016/j.anclin.2014.08.003. Epub 2014 Nov 25.
- Background: PubMed 15698919Campbell VL. Anesthetic protocols for common emergencies. Vet Clin North Am Small Anim Pract. 2005 Mar;35(2):435-53. doi: 10.1016/j.cvsm.2004.10.005.
- book chapter linkLink provided by the sponsor.
- bookLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Anesthesia
Recruiting
Postoperative Delirium and Analgesia in Elderly Patients
Postoperative Delirium, Postoperative Pain, Acute
RecruitingObservational study
Carotid Doppler Changes After Passive Leg Raising for Prediction of Post-Induction Hypotension in Gastrointestinal Tumor Surgery
Post-induction Hypotension (PIH), Gastrointestinal Tumor Surgery
Active, not recruiting
Safety and Efficacy of Conscious Sedation Versus General Anesthesia in Pulsed-Field Ablation for Paroxysmal Atrial Fibrillation
Atrial Fibrillation (Paroxysmal)
Recruiting
Exploration of Appropriate BIS Range and Propofol Effect-site Concentration During Total Intravenous Anesthesia With Concomitant Adjuvants.
Knee Osteoarthritis, Replacement, Knee
Recruiting
Processed Electroencephalography-guided General Anesthesia and Outcomes in Major Abdominal Surgery
Postoperative Acute Kidney Injury
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.
Ali F Erdem, Prof study chair
Sakarya University
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 Anesthesia, run by Sakarya University at 1 site in Turkey (Türkiye).
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: status not confirmed, as of the sponsor's last update on 1 Jul 2016. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Havva Sayhan, Assist Prof (+905056621021, hsayhan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with preferred anesthesia technique for orthopedic emergency surgery assessed by Statistical Package for the Social Sciences (SPSS) v22.0 (time frame: 1 year). 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 NCT02820922, 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 1 Jul 2016.