Clinical trial · Interventional
The Effect of Preoperative Duloxetine on the Occurance of Postoperative Delirium in Patients Undergoing Cancer Surgery.
The Effect of Preoperative Duloxetine on the Occurance of Postoperative Delirium in Patients Undergoing Cancer Surgery .
NCT05949229CI-TRIAL-00068050not yet recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is prospective double-blinded placebo-randomized controlled trial that aims to compare the effect of preoperative administration of oral duloxetine 60 mg on decreasing the incidence of postoperative delirium in cancer patients undergoing surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Post Operative Delirium | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Duloxetine 60 MG | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Duloxetine group (Group D)
- description
- patients received oral duloxetine 60 mg 2 hours just before operation.
- interventionNames
- Drug: Duloxetine 60 MG
- type
- PLACEBO_COMPARATOR
- label
- Control group (Group C)
- description
- patients received an identical placebo pill 2 hours just before operation.
- interventionNames
- Drug: Duloxetine 60 MG
Primary outcomes (1)
- measure
- postoperative delirium
- timeFrame
- 48 postoperative
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * All patients will sign an informed consent prior to inclusion in the study. * Adult patients with ASA class I-III, undergoing cancer surgery. Exclusion Criteria: * Patients with pre-existing neuro- cognitive dysfunction. * Documented signs of dementia after psychiatric evaluations. * Language barriers or deafness. * Psychosis stroke, meningitis, or brain tumors
References
Publications (5)
- BACKGROUNDRodrigues-Amorim D, Olivares JM, Spuch C, Rivera-Baltanas T. A Systematic Review of Efficacy, Safety, and Tolerability of Duloxetine. Front Psychiatry. 2020 Oct 23;11:554899. doi: 10.3389/fpsyt.2020.554899. eCollection 2020. PMID 33192668
- RESULTChen H, Jiang H, Chen B, Fan L, Shi W, Jin Y, Ren X, Lang L, Zhu F. The Incidence and Predictors of Postoperative Delirium After Brain Tumor Resection in Adults: A Cross-Sectional Survey. World Neurosurg. 2020 Aug;140:e129-e139. doi: 10.1016/j.wneu.2020.04.195. Epub 2020 May 4. PMID 32376378
- RESULTDos Santos FCM, Rego AS, Montenegro WS, de Carvalho STRF, Cutrim RC, Junior AAM, Pereira FHF, Dibai-Filho AV, Bassi-Dibai D. Delirium in the intensive care unit: identifying difficulties in applying the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). BMC Nurs. 2022 Nov 23;21(1):323. doi: 10.1186/s12912-022-01103-w. PMID 36419158
- RESULTHetta DF, Elgalaly NA, Hetta HF, Fattah Mohammad MA. Preoperative Duloxetine to improve acute pain and quality of recovery in patients undergoing modified radical mastectomy: A dose-ranging randomized controlled trial. J Clin Anesth. 2020 Dec;67:110007. doi: 10.1016/j.jclinane.2020.110007. Epub 2020 Aug 22. PMID 32847776
- RESULTOrmseth CH, LaHue SC, Oldham MA, Josephson SA, Whitaker E, Douglas VC. Predisposing and Precipitating Factors Associated With Delirium: A Systematic Review. JAMA Netw Open. 2023 Jan 3;6(1):e2249950. doi: 10.1001/jamanetworkopen.2022.49950. PMID 36607634