Researching the Affect of Sevoflurane in Cardiac Surgery on Delirium

Sponsor
Derince Training and Research Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05365165
Collaborator
(none)
2
1
6.6
0.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

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

Study Type:
Observational
Anticipated Enrollment :
2 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Researching the Affect of Sevoflurane Application for Maintenance of Anesthesia During Aortic Cross-clamping in Cardiac Surgery on Delirium
Actual Study Start Date :
Mar 15, 2022
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ayşegül Çiğdem Çağlayan Kocaeli Turkey

Sponsors and Collaborators

  • Derince Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aysegul Cigdem Caglayan, MD, Anesthesiology and Reanimation, Derince Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT05365165
Other Study ID Numbers:
  • DERINCETRHCCAGLAYAN002
First Posted:
May 9, 2022
Last Update Posted:
May 9, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 9, 2022