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

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

NCT ID: NCT05949229

Condition: Post Operative Delirium

Conditions: Official terms:
Delirium
Emergence Delirium
Duloxetine Hydrochloride

Conditions: Keywords:
Duloxetine, POD, postoperative dilrium

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: 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

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking description: The participating patients will be randomly allocated using computer generated randomizer program (http://www.randomizer.org) into 2 study groups .

Intervention:

Intervention type: Drug
Intervention name: Duloxetine 60 MG
Description: Patients will recieve 2-hour preoperative duloxetine
Arm group label: Control group (Group C)
Arm group label: Duloxetine group (Group D)

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.

Detailed description: 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. 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 Interventions: The preoperative anaesthetic assessment will be carried out including patient medical history , examination including baseline heart rate and blood pressure recording and review of patients' CBC , coagulation profile and chemistry investagations. In the operating room in all patients a large bore IV access (18 gauge) will be inserted. All patients will be connected to standard routine monitoring ( non-invasive blood pressure , electrocardiography and peripheral oxygen saturation) . patients will undergo surgery under general anasthesia [ induction with IV anaesthetics (propofol 2mg/kg ) , atracurium 0.5mg/kg and maintenance with inhalational anesthesia (sevoflurane and isoflurane ). patients will be transferred to ICU after surgery . 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. Data collection: Pre-operative data included: age, sex, ASA classification, smoking, tumor location , tumor stage, and history of medical disease. Intra-operative data included: duration of operation, blood loss, blood and fluid transfusion. Post-operative data included: length of hospital stay, and condition on discharge (living/dead). Sample size: Based on determining the main outcome variable, the estimated minimum required sample size is 42 patients (21 in each group). The sample size was calculated using G*power software 3.1.9.2., based on the following assumptions: Main outcome variable is the variation in CAM-ICU score used to evaluate postoperative delirium in cancer surgery patients who were administered preoperative duloxetine compared to those who received a placebo. Although no prior research has examined the impact of duloxetine on delirium, one study indicated that its use resulted in a considerably better postoperative recovery outcome than that of a placebo.(Hetta et al., 2020) Main statistical test is one-sided t-test to detect the difference between the two groups, Alpha = 0.05, Power = 0.80, Effect size = 0.8, Allocation ratio= 1 Statical analysis: Data will be analyzed using IBT SPSS advanced statistics version200(spss inc,Chicago , il) . Numerical data will be expressed as mean and standard deviation or median and range as appropriate. Qualitative data will be expressed as frequency and percentage chi-square test(fisher's exact test) will be used to examine. The relation between qualitative variables for quantitative data, comparison between two groups will be done using independent sample test or Mann Whiteny test . a P value 0.05 was considered statistically significant.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 20 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Faculty of medicine

Address:
City: Assiut
Zip: 71515
Country: Egypt

Start date: August 2023

Completion date: December 2026

Lead sponsor:
Agency: Amira Hassan Ahmed Ali
Agency class: Other

Source: Assiut University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05949229