Researching the Affect of Sevoflurane in Cardiac Surgery on Delirium
1 other identifier
observational
2
1 country
1
Brief 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. Therefore, patients will be weaned from the mechanical ventilator in a shorter time. Patients with shorter stays on mechanical ventilation develop less postoperative delirium.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 15, 2022
CompletedFirst Submitted
Initial submission to the registry
April 24, 2022
CompletedFirst Posted
Study publicly available on registry
May 9, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedMay 9, 2022
May 1, 2022
5 months
April 24, 2022
May 5, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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.
up to 2 weeks
Study Arms (1)
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.
Interventions
Sevoflurane will be applied during aortic cross- clamping in cardiac surgery
Eligibility Criteria
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.
You may qualify if:
- Patients with a score of 25 and above in the mini-mental state test performed in the preoperative period
You may not qualify if:
- Those who are scheduled for emergency surgery
- Those with known dementia and/or neurological disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ayşegül Çiğdem Çağlayan
Kocaeli, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Anesthesiology and Reanimation
Study Record Dates
First Submitted
April 24, 2022
First Posted
May 9, 2022
Study Start
March 15, 2022
Primary Completion
August 1, 2022
Study Completion
October 1, 2022
Last Updated
May 9, 2022
Record last verified: 2022-05