Postoperative DeliriumNCT05365165
Researching the Affect of Sevoflurane in Cardiac Surgery on Delirium
An observational study of Postoperative Delirium, run by Derince Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Many risk factors have been identified for delirium after open heart surgery . One of the main risk factors; duration of stay on mechanical ventilator . Our hypothesis; The use of sevoflurane during aortic cross-clamping reduces the need for long-acting intravenous anesthetic agents. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- Sevoflurane
- How many people
- 2 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2022to Oct 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who will have elective open heart surgery, patients over the age of 18, and patients with a score of 25 and above in the mini mental state test performed in the preoperative period will be included in the study.
Who may be able to join
- Patients with a score of 25 and above in the mini-mental state test performed in the preoperative period
Who cannot join
- Those who are scheduled for emergency surgery
- Those with known dementia and/or neurological disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ayşegül Çiğdem Çağlayan
Kocaeli
çiğdem çağlayan, +905055347107, cigdemxyalcin@gmail.com
About this study
Official title: Researching the Affect of Sevoflurane Application for Maintenance of Anesthesia During Aortic Cross-clamping in Cardiac Surgery on Delirium
Many risk factors have been identified for delirium after open heart surgery . One of the main risk factors; duration of stay on mechanical ventilator . Our hypothesis; The use of sevoflurane during aortic cross-clamping reduces the need for long-acting intravenous anesthetic agents. Therefore, patients will be weaned from the mechanical ventilator in a shorter time. Patients with shorter stays on mechanical ventilation develop less postoperative delirium.
Read the detailed description
Standard anesthesia management will be applied in the induction and maintenance of anesthesia. In the induction of anesthesia 1mg/kg lidocaine , 1.5-2mg/kg propofol , 1 mcg /kg fentanyl citrate, 0.6 mg/kg rocuronium bromide will be administered. Sevoflurane for maintenance of anesthesia and propofol and fentanyl if needed bolus will be applied. BIS monitoring will be performed to control the depth of anesthesia. Patients' peroperative hemodynamic levels, arterial blood gas levels, operation time, pump time, aortic cross clamp time, postoperative complications , the amount of blood and fluid used, the amount of iv anesthetic used, the extubation time, the length of stay in the intensive care unit, the length of stay in the hospital will be followed and recorded. Postoperative delirium follow-ups of the patients will be recorded once a day by the same investigator using the Nursing Delirium Screening Scale and Delirium Rating Scale Revised-98 until they are discharged from the hospital .
- Conditions
- Postoperative Delirium
- Being tested
- Sevoflurane
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Sevoflurane will be applied during aortic cross- clamping in cardiac surgery
| Study group | Role | What they receive |
|---|---|---|
| sevoflurane | Standard anesthesia management will be applied in the induction and maintenance of anesthesia. In the induction of anesthesia 1mg/kg lidocaine , 1.5-2mg/kg propofol , 1 mcg /kg fentanyl citrate, 0.6 mg/kg rocuronium bromide will be administered. Sevoflurane for maintenance of anesthesia and propofol and fentanyl if needed bolus will be applied. BIS monitoring will be performed to control the depth of anesthesia. Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of delirium after open heart surgery
Postoperative delirium follow-ups of the patients will be recorded once a day by the same investigator using the Nursing Delirium Screening Scale and Delirium Rating Scale Revised-98 until they are discharged from the hospital. The Nu-DESC is a 5-item observation scale that can be completed quickly. Each item is evaluated on a 3-point Likert (from 0 to 3). The total score is obtained by adding the values of the items, and the highest score is 10. If the total score is 2 and above, the diagnosed of delirium is made. The DRS-R-98 is a 16-item scale with a maximum total scale score of 46 points and a maximum severity score of 39 points. A suggested cut-off score for delirium is >19 points.
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start15 Mar 2022
- Primary completionAug 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies 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
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Derince Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysegul Cigdem Caglayan, Derince Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365165
- Sponsor's protocol ID
- DERINCETRHCCAGLAYAN002
- Status last verified
- May 2022
- First submitted
- 24 Apr 2022
- Last updated
- 9 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Researching the Affect of Sevoflurane Application for Maintenance of Anesthesia During Aortic Cross-clamping in Cardiac Surgery on Delirium
- ClinicalTrials.gov ID
- NCT05365165
- Acronym / sponsor ID
- DERINCETRHCCAGLAYAN002
- Conditions
- Postoperative Delirium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Derince Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 9 May 2022 (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.
Many risk factors have been identified for delirium after open heart surgery . One of the main risk factors; duration of stay on mechanical ventilator . Our hypothesis; The use of sevoflurane during aortic cross-clamping reduces the need for long-acting intravenous anesthetic agents. Therefore, patients will be weaned from the mechanical ventilator in a shorter time. Patients with shorter stays on mechanical ventilation develop less postoperative delirium.
Detailed description
Standard anesthesia management will be applied in the induction and maintenance of anesthesia. In the induction of anesthesia 1mg/kg lidocaine , 1.5-2mg/kg propofol , 1 mcg /kg fentanyl citrate, 0.6 mg/kg rocuronium bromide will be administered. Sevoflurane for maintenance of anesthesia and propofol and fentanyl if needed bolus will be applied. BIS monitoring will be performed to control the depth of anesthesia. Patients' peroperative hemodynamic levels, arterial blood gas levels, operation time, pump time, aortic cross clamp time, postoperative complications , the amount of blood and fluid used, the amount of iv anesthetic used, the extubation time, the length of stay in the intensive care unit, the length of stay in the hospital will be followed and recorded. Postoperative delirium follow-ups of the patients will be recorded once a day by the same investigator using the Nursing Delirium Screening Scale and Delirium Rating Scale Revised-98 until they are discharged from the hospital .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sevoflurane | – | Drug: SevofluraneStandard anesthesia management will be applied in the induction and maintenance of anesthesia. In the induction of anesthesia 1mg/kg lidocaine , 1.5-2mg/kg propofol , 1 mcg /kg fentanyl citrate, 0.6 mg/kg rocuronium bromide will be administered. Sevoflurane for maintenance of anesthesia and propofol and fentanyl if needed bolus will be applied. BIS monitoring will be performed to control the depth of anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will have elective open heart surgery, patients over the age of 18, and patients with a score of 25 and above in the mini mental state test performed in the preoperative period will be included in the study.
Key inclusion criteria (1 listed)
- Patients with a score of 25 and above in the mini-mental state test performed in the preoperative period
Key exclusion criteria (2 listed)
- Those who are scheduled for emergency surgery
- Those with known dementia and/or neurological disease
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 |
|---|---|---|
| SevofluraneSevoflurane will be applied during aortic cross- clamping in cardiac surgery | Drug | sevoflurane |
Primary outcome
rate of delirium after open heart surgery
Time frame: up to 2 weeks
Postoperative delirium follow-ups of the patients will be recorded once a day by the same investigator using the Nursing Delirium Screening Scale and Delirium Rating Scale Revised-98 until they are discharged from the hospital. The Nu-DESC is a 5-item observation scale that can be completed quickly. Each item is evaluated on a 3-point Likert (from 0 to 3). The total score is obtained by adding the values of the items, and the highest score is 10. If the total score is 2 and above, the diagnosed of delirium is made. The DRS-R-98 is a 16-item scale with a maximum total scale score of 46 points and a maximum severity score of 39 points. A suggested cut-off score for delirium is >19 points.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Individual participant dataSharing planned: Undecided
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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.
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 Postoperative Delirium, run by Derince Training and Research Hospital 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 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: status not confirmed, as of the sponsor's last update on 9 May 2022. 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 Mehmet Yılmaz (+902623178000, drmyilmaz33@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of delirium after open heart surgery (time frame: up to 2 weeks). 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 9 May 2022.