The Efficacy of risperidone oral solution for reducing the incidence of postoperative delirium in vascular patients: a randomized controlled trial

Phase 1

• Conditions: vascular patients; postoperative delirium, POD, vascular surgery, CAM- ICU, risperidone oral solution

• Registration Number: TCTR20190704003
• Lead Sponsor: Faculty of Medicine Siriraj Hospital, Mahidol University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-04
• Study Completion: 2021-01-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1. patients aged > 60 years
2. undergoing elective vascular surgery
3. operative time > 2 hours.

Exclusion Criteria

1. patients with cognitive impairment (a Thai Mental State Examination score < 24)
2. evidence of alcohol abuse
3. alcohol ingestion occurring in the 14-day period preceding the surgery
4. preoperative delirium (shown by a positive result with the Confusion Assessment Method for the Intensive Care Unit, CAM-ICU)
5. severely impaired renal function (demonstrated by a creatinine clearance < 30 mL/min/1.72 m2)
6. hepatic impairment (a Child Pugh score ≥ 10)
7. allergy to risperidone
8. neuroleptic malignant syndrome

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
delirium Admitted to an SICU for a period that was expected to be longer than 24 hour The CAM−ICU score

Secondary Outcome Measures

Name	Time	Method
/A N/A N/A