Researching the Affect of Sevoflurane in Cardiac Surgery on Delirium

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Delirium
• Intervention / Treatment: Drug: Sevoflurane

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 Type: Observational
• Enrollment (Anticipated): 2

Contacts and Locations

• Study Contact: Name: Mehmet Yılmaz; Phone Number: +902623178000; Email: drmyilmaz33@gmail.com

Study Locations

• Turkey
  • Kocaeli, Turkey
    • Recruiting
    • Ayşegül Çiğdem Çağlayan
    • Contact: çiğdem çağlayan; Phone Number: +905055347107; Email: cigdemxyalcin@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Derince Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: April 24, 2022
• First Submitted That Met QC Criteria: May 5, 2022
• First Posted (Actual): May 9, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2022
• Last Update Submitted That Met QC Criteria: May 5, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Anesthetics, Inhalation; Sevoflurane
• Other Study ID Numbers: DERINCETRHCCAGLAYAN002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No