The Effect of Preoperative Duloxetine on the Occurance of Postoperative Delirium in Patients Undergoing Cancer Surgery.

NCT05949229 | Not Yet Recruiting Phase 1

• 1 other identifier: Pain management
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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

Post Operative Delirium

Keywords

Duloxetine, POD, postoperative dilrium

Outcome Measures

Primary Outcomes (1)

• postoperative delirium

  Patients that will recieve preoperative duloxetine will transported to ICU .CAM-ICU will be measured every eight hours (three times a day) until the patient wiil be discharged from the ICU. Positive CAM-ICU will be considered to be delirium.

  48 postoperative

Study Arms (2)

Duloxetine group (Group D)

EXPERIMENTAL

patients received oral duloxetine 60 mg 2 hours just before operation.

Drug: Duloxetine 60 MG

Control group (Group C)

PLACEBO COMPARATOR

patients received an identical placebo pill 2 hours just before operation.

Drug: Duloxetine 60 MG

Interventions

Duloxetine 60 MG DRUG

Patients will recieve 2-hour preoperative duloxetine

Control group (Group C); Duloxetine group (Group D)

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with ASA class I-III, undergoing cancer surgery.

You may not qualify if:

• Patients with pre-existing neuro- cognitive dysfunction.
• Documented signs of dementia after psychiatric evaluations.
• Language barriers or deafness.
• Psychosis stroke, meningitis, or brain tumors

Sponsors & Collaborators

• Amira Hassan Ahmed Ali: lead

Study Sites (1)

Faculty of medicine

Asyut, 71515, Egypt

Location

Related Publications (5)

• Rodrigues-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 BACKGROUND

• Chen 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 RESULT

• Dos 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 RESULT

• Hetta 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 RESULT

• Ormseth 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 RESULT

MeSH Terms

Conditions

Emergence Delirium

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Amira Hassan Ahmed, resident

  Faculty of medecine,assiut,Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amira Hassan Ahmed, resident

CONTACT

+201004387008; ah3421515@gmail.com

Amira Hassan Ahmed, resident

CONTACT

+201004387008; www.gaza90@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participating patients will be randomly allocated using computer generated randomizer program (http://www.randomizer.org) into 2 study groups .
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Egypt , Assiut governorate.

Model Details: The participating patients will be randomly allocated using computer generated randomizer program (http://www.randomizer.org) into 2 study groups . Duloxetine group (Group D): patients received oral duloxetine 60 mg 2 hours just before operation. Control group (Group C): patients received an identical placebo pill 2 hours just before operation

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: July 17, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 17, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)