Effects of Hypothermia on Delayed Neurocognitive Recovery (DNR): an Observational Trial Among Patients Undergoing Cardiac-Surgery

Completed

• Conditions: Emergence Delirium; Hypothermia; Cognitive Dysfunction

• Registration Number: NCT03636074
• Lead Sponsor: University of Padova

Brief Summary

Post-operative cognitive dysfunction is a common disease in patient undergoing general anaesthesia, especially in older patients. No correlations have been yet studied between intraoperative hypothermia and incidence of Delayed Neurocognitive Recovery. Investigators are going to estimate the Relative Risk of Hypothermia and emergence of Post-operative cognitive dysfunction in cardiac-surgery patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-07
• Study First Submitted QC: 2018-08-15
• Study First Posted: 2018-08-17
• Study Start: 2020-01-07
• Primary Completion: 2023-05-30
• Study Completion: 2023-06-12
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-06
• Last Update Posted: 2023-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

• Adults patients undergoing Cardiac - Surgery intervention with extracorporeal circulation

Exclusion Criteria

• Neurological disease before surgery
• Sedation in Cardiac-Surgery Intensive Unit > 6 hours
• Cerebral regional Oxygen saturation <20% baseline during surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Delayed Neurocognitive Recovery in Cardiac-Surgery	Patients will be subjected to Frontal Assessment Battery test one day before surgery and 4-6 days after surgery	Discover changes between pre-operative Frontal Assessment Battery test score and post-operative Frontal Assessment Battery test score and

Secondary Outcome Measures

Name	Time	Method
Effects of hypothermia during Extracorporeal Circulation in Cardiac Surgery	One day before surgery and 4-6 days after surgery patients will be subjected to cognitive test to diagnosticate Post-Operative Cognitive Decline	Discover statistical significance difference in incidence of Post-Operative Cognitive Decline between patients undergoing normothermia and patients undergoing hypothermia during Extracorporeal Circulation in Cardiac Surgery

Trial Locations

Locations (1)

Università degli Studi di Padova; 🇮🇹 Padova, PD, Italy