Researching the Affect of Sevoflurane in Cardiac Surgery on Delirium

Postoperative Delirium Clinical Trial

Official title:

Researching the Affect of Sevoflurane Application for Maintenance of Anesthesia During Aortic Cross-clamping in Cardiac Surgery on Delirium

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05365165
• Other study ID #: DERINCETRHCCAGLAYAN002
• Status: Recruiting
• Start date: March 15, 2022
• Est. completion date: October 2022

Study information

• Verified date: May 2022
• Source: Derince Training and Research Hospital
• Contact: Mehmet Yilmaz
• Phone: +902623178000
• Email: drmyilmaz33[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Therefore, patients will be weaned from the mechanical ventilator in a shorter time. Patients with shorter stays on mechanical ventilation develop less postoperative delirium.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2
• Est. completion date: October 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients with a score of 25 and above in the mini-mental state test performed in the preoperative period

Exclusion Criteria:

Those who are scheduled for emergency surgery

Those with known dementia and/or neurological disease

Related Conditions & MeSH terms

• Delirium
• Postoperative Delirium

Intervention

Drug:
• Sevoflurane
Sevoflurane will be applied during aortic cross- clamping in cardiac surgery

Locations

Country	Name	City	State
Turkey	Aysegül Çigdem Çaglayan	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Derince Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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