Post-surgical Delirium in Patients Undergoing Open Heart Surgery.

Not yet recruiting

• Conditions: Open Heart Surgery; Delirium
• Interventions: Other: Open heart surgery

• Registration Number: NCT03806413
• Lead Sponsor: University of Alexandria

Brief Summary

Post-surgical delirium in patients undergoing open heart surgery. Introduction Delirium occurs after open heart surgery may reach about 1/3 of the patients.(1)

Aim The aim of this study is to determine the incidence of delirium after open heart surgery and the associated risk factors in Alexandria University hospital.

Patients and Methods The study will be done on patients undergoing open heart surgery in Alexandria University hospitals from January 5th 2019 till January 4th 2020. The 6-item Cognitive Impairment Test (6CIT) and SPMSQ questionnaire will be used. SPMSQ will be done preoperative and daily for 3 days postoperative, at day 7. Phone call for SPMSQ will be done 3, 6 9 and 12 months after surgery.

Detailed Description

Post-surgical delirium in patients undergoing open heart surgery. Introduction Delirium occurs after open heart surgery may reach about 1/3 of the patients.(1)

Aim The aim of this study is to determine the incidence of delirium after open heart surgery and the associated risk factors in Alexandria University hospital.

Patients and Methods The study will be done on patients undergoing open heart surgery in Alexandria University hospitals from January 5th 2019 till January 4th 2020. The 6-item Cognitive Impairment Test (6CIT) and SPMSQ questionnaire will be used. SPMSQ will be done preoperative and daily for 3 days postoperative, at day 7. Phone call for SPMSQ will be done 3, 6 9 and 12 months after surgery.

Results Results will be collected in tables and graphs. Appropriate statistical analysis will be done.

Discussion Results of the study will be discussed compared to other studies.

References

1-Jannati Y, Bagheri-Nesami M, Sohrabi M, Yazdani-Cherati J, Mazdarani S. Factors associated with post-surgical delirium in patients undergoing open heart surgery. Oman Med J. 2014 Sep;29(5):340-5.

Study Timeline

• Study First Submitted: 2019-01-05
• Study First Submitted QC: 2019-01-15
• Study First Posted: 2019-01-16
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-03
• Study Start: 2028-10-01
• Primary Completion: 2029-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Adult patients undergoing open heart surgery. -

Exclusion Criteria

Children, patient refusal.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Open heart surgery	Open heart surgery	The study will be done on patients undergoing open heart surgery in Alexandria University hospitals from January 5th 2019 till January 4th 2020. The 6-item Cognitive Impairment Test (6CIT) and SPMSQ questionnaire will be used. SPMSQ will be done preoperative and daily for 3 days postoperative, at day 7. Phone call for SPMSQ will be done 3, 6 9 and 12 months after surgery.

Primary Outcome Measures

Name	Time	Method
Post-surgical delirium in patients undergoing open heart surgery.	1 year	Post-surgical delirium in patients undergoing open heart surgery.

Secondary Outcome Measures

Name	Time	Method
Mortality	1 year	Mortality

Trial Locations

Locations (1)

Alexandria Faculty of Medicine; 🇪🇬 Alexandria, Egypt