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

ConditionPost Operative Delirium

Trial statusNot yet recruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age20-80

SponsorAmira Hassan Ahmed Ali

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All patients will sign an informed consent prior to inclusion in the study.

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

Disqualifiers

Patients with pre-existing neuro- cognitive dysfunction.

Documented signs of dementia after psychiatric evaluations.

Language barriers or deafness.

Psychosis stroke, meningitis, or brain tumors

Trial design

Design model

Parallel

Treatments tested in this trial

Duloxetine 60 MG
Drug
Patients will recieve 2-hour preoperative duloxetine

Treatment groups

42 Participants

are divided into 2 treatment groups

Group A: Duloxetine group (Group D)Experimental treatment 1 intervention

Group B: Control group (Group C)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

48 postoperative

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amira Hassan Ahmed Ali

Lead sponsor

Assiut University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: