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Not Yet Recruiting NCT07766603

Preoperative Breathing Exercise Training and Postoperative Delirium After Robotic Radical Prostatectomy

Conditions: Postoperative Delirium (POD), Prostate Cancer

Sex: Male
Ages: 40 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: ALİ DEMİRTAŞ

Location: Akdeniz University Hospital Antalya Antalya

Summary

Postoperative delirium is an acute and fluctuating disturbance in attention, awareness, and thinking that may occur after major surgery. Patients undergoing robot-assisted radical prostatectomy may be at risk because of factors such as older age, general anesthesia, prolonged surgery, pneumoperitoneum, and steep Trendelenburg positioning. This single-center, prospective, two-arm controlled pilot study will evaluate whether preoperative deep breathing exercise training is associated with a lower occurrence of postoperative delirium in patients undergoing elective robot-assisted radical prostatectomy. A total of 50 patients will be included, with 25 patients in the breathing exercise training group and 25 patients in the control group. Patients in the breathing exercise training group will receive standardized, device-free deep breathing exercise instruction during the preoperative period, usually approximately one week before surgery. They will be asked to perform three sessions per day until surgery, with 10 deep breaths in each session. Patients in the control group will receive routine preoperative information without additional structured breathing exercise training. Postoperative delirium will be assessed during the first 48 hours after surgery using the 4AT and Nursing Delirium Screening Scale (Nu-DESC). The study will also evaluate postoperative oxygenation, oxygen requirement, pain, nausea and vomiting, respiratory complications, intensive care requirement, and length of hospital stay. The study will not alter routine anesthesia, surgery, or postoperative treatment, and no additional invasive procedures, laboratory tests, or imaging will be performed for research purposes.

Eligibility Criteria

Inclusion Criteria: * Male patients aged 40 years or older. * Scheduled to undergo elective robot-assisted radical prostatectomy (RARP) at -Akdeniz University Hospital. * Able to communicate and suitable for preoperative and postoperative -cognitive/delirium assessment using the 4AT and Nu-DESC. * Able and willing to provide written informed consent. * Availability of clinical follow-up data during the first 48 postoperative hours. Exclusion Criteria: * Refusal to participate or withdrawal of informed consent. * History of delirium, severe dementia, severe cognitive impairment, or an active neurological disorder that would interfere with delirium assessment. * Active psychosis, severe psychiatric disease, or use of psychoactive medication that could substantially affect cognitive assessment. * Level of consciousness not allowing assessment, or severe hearing or speech impairment preventing adequate communication. * Emergency surgery or failure to complete the planned procedure as robot-assisted radical prostatectomy. * Inability to complete the postoperative 4AT and/or Nu-DESC assessments or substantial missing data affecting the primary analysis. * Inability to tolerate the breathing exercises or insufficient home exercise adherence/follow-up data for the planned analysis.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07766603). StuddyBuddy aggregates publicly available trial information.