RecruitingPhase 3ACTRN12622000862741

Managing Delirium with FLUvoxamine treatment in Non-Cardiac Surgical patients: a feasibility trial


Sponsor

Royal Prince Alfred Hosptial

Enrollment

46 participants

Start Date

Sep 18, 2023

Study Type

Interventional

Conditions

Summary

Double-blind placebo-controlled randomised controlled feasibility trial to assess the feasibility of a larger multi-centre study. The rationale for the study are based on the known action of the drug fluvoxamine to reduce inflammation in the brain. The main objective of this pilot is to determine feasibility on a larger scale - including rate of recruitment, adherence to drug, ability to preform research activities and reporting adverse events related to the drug. As this is a pilot study our hypothesis is that more than 25% of patients approached will be happy to enrol in the study, 80% of enrolled participants will adhere to the study drug schedule and we will be able to collect measurable information on 90% of the participants. Secondary objectives include instance and severity of post-operative delirium, changes in EEG from intra-operative recording to and post-operative day 1, and collecting blood results/bio-markers associated with inflammation. Previous randomised control trials of prophylactic interventions to treat delirium have shown modest effectiveness. The intervention (Fluvoxamine 100mg oral tablet) or placebo will be administered on the evening prior to surgery, day of surgery and post-operative day one. Participants will be asked to partake in cognitive assessments, delirium assessments and have routine bloods drawn as part of daily research activities.


Eligibility

Sex: Both males and femalesMin Age: 60 Yearss

Plain Language Summary

Simplified for easier understanding

Delirium — a sudden state of confusion, disorientation, and agitation — is a common and serious complication after surgery, particularly in older patients. It can prolong hospital stays, increase the risk of further complications, and is distressing for patients and families. This study tests whether a medication called fluvoxamine (a common antidepressant that also reduces brain inflammation) can prevent post-operative delirium when given around the time of surgery. Participants aged 60 and over who are having non-cardiac, non-brain surgery will be randomly assigned to receive either fluvoxamine or a placebo (dummy tablet) on the evening before surgery, the day of surgery, and the day after. Researchers will assess whether delirium occurs, and will also collect EEG brain recordings and blood markers of inflammation to understand the biological mechanisms. You may be eligible if you are 60 years or older, scheduled for elective non-cardiac surgery, and expected to stay in hospital for at least 2 days. People who don't speak English, take medications that interact with fluvoxamine, lack decision-making capacity, or require a breathing tube after surgery would not be eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Oral Fluvoxamine 100 mg tablets (immediate release) Study drug (100mg Fluvoxamine tablet or placebo) will be administered at the following times: 1) Day of surgery - Study drug to be taken morning

Oral Fluvoxamine 100 mg tablets (immediate release) Study drug (100mg Fluvoxamine tablet or placebo) will be administered at the following times: 1) Day of surgery - Study drug to be taken morning of surgery and evening of surgery 2) Post-operative day 1 - Study drug to be taken morning and evening On day of surgery if the patient is arriving in the morning they will be given the study drug by a registered nurse (RN) in admissions or they will self administer if not arriving until later. On the evening of surgery and post-operative day 1 the study drug will be administered, witnessed and signed off on the electronic medication chart by an RN.


Locations(2)

Royal Prince Alfred Hospital - Camperdown

NSW, Australia

Washington, United States of America

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ACTRN12622000862741


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