Epidural AnalgesiaNCT04708080
Effects of Thoracic Epidural Analgesia in Geriatric Patients Undergoing Open Heart Surgery
An observational study of Epidural Analgesia and Mechanical Ventilation, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
Elderly patients have a higher incidence of morbidity and mortality due to the interaction of various factors such as decreased physiological reserves, concomitant comorbidities, multiple drug use, cognitive dysfunction, and frailty. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epidural Analgesia, Mechanical Ventilation, Postoperative Complications
- What is being tested?
- thoracic epidural analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 640 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2020to 15 Feb 2021
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: This study was planned as a retrospective (retrospective) study involving patients aged 65 and over who underwent elective open heart surgery between January 1, 2008 and December 31, 2019.
Who may be able to join
- Elective patients undergoing open heart surgery
Who cannot join
- Emergency operations
- Patients whose data cannot be reached
- Patients younger than 65
- Patients whose records could not be accessed and who were excluded from the study group procedure in which they were included for any reason will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Thoracic Epidural Analgesia on Short-term Outcome and Mortality in Geriatric Patients With Open Heart Surgery
Elderly patients have a higher incidence of morbidity and mortality due to the interaction of various factors such as decreased physiological reserves, concomitant comorbidities, multiple drug use, cognitive dysfunction, and frailty. Surgical stress, pain and associated lung complications are common problems in open heart surgeries that can affect morbidity and mortality. With a good postoperative pain control and improved respiratory mechanics, complications that may develop in patients can be significantly prevented, and the hospital cost can be reduced and the workforce loss of patients can be reduced by reducing the length of hospital stay in the intensive care unit. Thoracic epidural analgesia (TEA) is an anesthetic analgesia method that has positive effects on many organ systems as well as providing good pain control and is frequently used in open heart surgery. The aim of this study is to investigate the effects of TEA on postoperative respiratory mechanics in geriatric patients, based on analgesia levels, extubation times, length of stay in intensive care, arterial blood gases, morbidity and mortality.
Read the detailed description
It has been shown that stress response suppression by providing good analgesia with local or systemic methods in the postoperative period reduces mortality and morbidity in many types of surgery. Especially the physiological changes that occur with aging, comorbid diseases and the drugs used in the treatment of these diseases, the type of surgery performed, the postoperative pain treatment and the anesthesia method chosen affect mortality and morbidity Thoracic epidural analgesia (TEA) has provided similar benefits in open heart surgery by suppressing stress response and increasing functional residual capacity with positive effects on the diaphragm, as well as providing good analgesia with thoracic sympathetic block.TEA has positive effects on postoperative pulmonary and circulatory system in selected eligible patients; It allows earlier extubation and provides excellent analgesia. It has been reported that TEA combined with general anesthesia in elective cardiac surgery offers a significant advantage compared to general anesthesia in terms of intensive care and hospital stay, improvement or morbidity. Studies have shown that TEA reduces surgical stress response, improves hemodynamic stability, and reduces the incidence of myocardial ischemia after coronary artery bypass surgery (CABG) as well as supraventricular arrhythmias in the postoperative period .
Based on these studies, the investigators determined the effects of TEA combined with general anesthesia on postoperative respiratory mechanics, analgesia levels, extubation times, length of stay in intensive care, arterial blood gases, effects on organ functions, morbidity and mortality in geriatric patients with open heart surgery in our hospital. the investigators aimed to contribute to the literature by reviewing it retrospectively.
- Being tested
- thoracic epidural analgesia
- Keywords
- thoracic epidural analgesia, Postoperative Complications, mortality, Mechanical Ventilation, open heart surgery
- Medical subject headings
- Postoperative Complications, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracic epidural analgesiaProcedure or surgery
A thoracic epidural catheter is routinely placed in patients undergoing open heart surgery in our hospital, at least 1 hour before heparin administration during the operation. After standard monitoring (ECG, SpO2, NIBP) is applied to the patients in the operating room, sedoanalgesia is provided with 1-3mg of midazolam and 50-100mcg of fentanyl. Then, by providing sterilization conditions, an epidural catheter is inserted through the T5-T6 interval with Tuohy needle. After confirming the location of the epidural catheter, 25mg / 10ml bupivacaine is administered as a bolus and then 3ml / hour bupivacaine infusion is started from the solution prepared as 3mg / ml and continues until the 48th postoperative hour. On the postoperative 2nd day, the catheter is removed 10-12 hours after LMWH administration and 2-4 hours after UFH, as recommended by the guidelines, paying attention to the anticoagulant administration times applied to the patients.
| Study group | Role | What they receive |
|---|---|---|
| Group E | patients who underwent thoracic epidural catheter for postoperative analgesia Receives: Procedure: thoracic epidural analgesia | |
| Group I | Patients who cannot be applied thoracic epidural catheter for postoperative analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effect of thoracic epidural analgesia
postoperative respiratory parameters
Measured: up to 4 weeks
the effect of thoracic epidural analgesia
Patients' sedation and analgesia levels
Measured: postoperative period 3 day
the effect of thoracic epidural analgesia
extubation times
Measured: 1 day
the effect of thoracic epidural analgesia
postoperative respiratory complications
Measured: 1 month
the effect of thoracic epidural analgesia
lengths of ICU and hospitality stay
Measured: up to 4 weeks
the effect of thoracic epidural analgesia
mortality
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start1 Jul 2020
- Primary completion1 Feb 2021
- Study completion15 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidural AnalgesiaStudies 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
- Retrospective
- Enrolment
- 640 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali AKDOĞAN, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708080
- Sponsor's protocol ID
- 2020/182
- Status last verified
- Feb 2021
- First submitted
- 8 Jan 2021
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Thoracic Epidural Analgesia on Short-term Outcome and Mortality in Geriatric Patients With Open Heart Surgery
- ClinicalTrials.gov ID
- NCT04708080
- Acronym / sponsor ID
- 2020/182
- Keywords
- thoracic epidural analgesia, Postoperative Complications, mortality, Mechanical Ventilation, open heart surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 640 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 13 Jan 2021 (actual)
- 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.
Elderly patients have a higher incidence of morbidity and mortality due to the interaction of various factors such as decreased physiological reserves, concomitant comorbidities, multiple drug use, cognitive dysfunction, and frailty. Surgical stress, pain and associated lung complications are common problems in open heart surgeries that can affect morbidity and mortality. With a good postoperative pain control and improved respiratory mechanics, complications that may develop in patients can be significantly prevented, and the hospital cost can be reduced and the workforce loss of patients can be reduced by reducing the length of hospital stay in the intensive care unit. Thoracic epidural analgesia (TEA) is an anesthetic analgesia method that has positive effects on many organ systems as well as providing good pain control and is frequently used in open heart surgery. The aim of this study is to investigate the effects of TEA on postoperative respiratory mechanics in geriatric patients, based on analgesia levels, extubation times, length of stay in intensive care, arterial blood gases, morbidity and mortality.
Detailed description
It has been shown that stress response suppression by providing good analgesia with local or systemic methods in the postoperative period reduces mortality and morbidity in many types of surgery. Especially the physiological changes that occur with aging, comorbid diseases and the drugs used in the treatment of these diseases, the type of surgery performed, the postoperative pain treatment and the anesthesia method chosen affect mortality and morbidity Thoracic epidural analgesia (TEA) has provided similar benefits in open heart surgery by suppressing stress response and increasing functional residual capacity with positive effects on the diaphragm, as well as providing good analgesia with thoracic sympathetic block.TEA has positive effects on postoperative pulmonary and circulatory system in selected eligible patients; It allows earlier extubation and provides excellent analgesia. It has been reported that TEA combined with general anesthesia in elective cardiac surgery offers a significant advantage compared to general anesthesia in terms of intensive care and hospital stay, improvement or morbidity. Studies have shown that TEA reduces surgical stress response, improves hemodynamic stability, and reduces the incidence of myocardial ischemia after coronary artery bypass surgery (CABG) as well as supraventricular arrhythmias in the postoperative period .
Based on these studies, the investigators determined the effects of TEA combined with general anesthesia on postoperative respiratory mechanics, analgesia levels, extubation times, length of stay in intensive care, arterial blood gases, effects on organ functions, morbidity and mortality in geriatric patients with open heart surgery in our hospital. the investigators aimed to contribute to the literature by reviewing it retrospectively.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group E | – | Procedure: thoracic epidural analgesiapatients who underwent thoracic epidural catheter for postoperative analgesia |
| Group I | – | –Patients who cannot be applied thoracic epidural catheter for postoperative analgesia |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- This study was planned as a retrospective (retrospective) study involving patients aged 65 and over who underwent elective open heart surgery between January 1, 2008 and December 31, 2019.
Key inclusion criteria (1 listed)
- Elective patients undergoing open heart surgery
Key exclusion criteria (4 listed)
- Emergency operations
- Patients whose data cannot be reached
- Patients younger than 65
- Patients whose records could not be accessed and who were excluded from the study group procedure in which they were included for any reason will not be included in the study.
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 |
|---|---|---|
| thoracic epidural analgesiaA thoracic epidural catheter is routinely placed in patients undergoing open heart surgery in our hospital, at least 1 hour before heparin administration during the operation. After standard monitoring (ECG, SpO2, NIBP) is applied to the patients in the operating room, sedoanalgesia is provided with 1-3mg of midazolam and 50-100mcg of fentanyl. Then, by providing sterilization conditions, an epidural catheter is inserted through the T5-T6 interval with Tuohy needle. After confirming the location of the epidural catheter, 25mg / 10ml bupivacaine is administered as a bolus and then 3ml / hour bupivacaine infusion is started from the solution prepared as 3mg / ml and continues until the 48th postoperative hour. On the postoperative 2nd day, the catheter is removed 10-12 hours after LMWH administration and 2-4 hours after UFH, as recommended by the guidelines, paying attention to the anticoagulant administration times applied to the patients. | Procedure or surgery | Group E |
Primary outcome
the effect of thoracic epidural analgesia
Time frame: up to 4 weeks
postoperative respiratory parameters
the effect of thoracic epidural analgesia
Time frame: postoperative period 3 day
Patients' sedation and analgesia levels
the effect of thoracic epidural analgesia
Time frame: 1 day
extubation times
the effect of thoracic epidural analgesia
Time frame: 1 month
postoperative respiratory complications
the effect of thoracic epidural analgesia
Time frame: up to 4 weeks
lengths of ICU and hospitality stay
the effect of thoracic epidural analgesia
Time frame: 1 year
mortality
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 2 Mar 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Epidural Analgesia and Mechanical Ventilation, run by Karadeniz Technical 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 4 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 2 Mar 2021. 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?
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?
the effect of thoracic epidural analgesia (time frame: up to 4 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2021.