Researching the Affect of Sevoflurane in Cardiac Surgery on Delirium

• Conditions: Postoperative Delirium
• Interventions: Drug: Sevoflurane

• Registration Number: NCT05365165
• Lead Sponsor: Derince Training and Research Hospital

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.

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 Timeline

• Study Start: 2022-03-15
• Study First Submitted: 2022-04-24
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-05
• Last Update Submitted: 2022-05-05
• Study First Posted: 2022-05-09
• Last Update Posted: 2022-05-09
• Primary Completion: 2022-08
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
sevoflurane	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.

Primary Outcome Measures

Name	Time	Method
rate of delirium after open heart surgery	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.

Trial Locations

Locations (1)

Ayşegül Çiğdem Çağlayan; 🇹🇷 Kocaeli, Turkey