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Quetiapine for Prophylaxis of Postoperative Delirium
NCT03739476Phase 3
Key facts
- Status
- Terminated
- Start
- Feb 2019
- Primary completion
- Apr 2020
- Countries
- 1
- Sponsor
- Fundación Instituto de Ciencias de la Salud de Castilla y León
- Modality
- Small Molecules
- Conditions
- postoperative delirium (POD)
01
Overview
Phase 3, randomised, double-blind trial in postoperative delirium (POD) comparing Quetiapine Arm with Placebo Arm (2 arms). Primary endpoint: Incidence of postoperative delirium at 28 days. Started Feb 2019; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Quetiapine Arm
Active quetiapine treatment group
Placebo Arm
Placebo control group
03
Endpoints
Primary
Incidence of postoperative delirium
Secondary
Days without delirium
Duration of delirium
Severity of delirium
Dose of other antipsychotic (haloperidol)
Degree of sedation
Measurement of corrected QT interval (QTc) prolongation
Evaluation of extrapyramidal symptoms
Days in hospital from surgery
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