The comparative analysis of post-operative delirium incidence: sevoflurane vs propofol in geriatric patients under general anaesthesia

To compare the incidence of postoperative delirium in elderly patients receiving propofol-based versus sevoflurane-based general anesthesia

A randomised, parallel group, superiority clinical trial comparing propofol-based versus sevoflurane-based anesthesia in elderly surgical patients, with concealed allocation and blinded outcome assessment using the Confusion Assessment Method over seven postoperative days.The study enrolled 200 patients, with 100 patients in each group.

The study was conducted at the Department of Anesthesia, Allied Hospital, Faisalabad over 6 months. After ethical approval and informed consent, patients aged 60–90 years undergoing elective moderate-risk surgery under general anesthesia were randomly assigned to receive either propofol- or sevoflurane-based anesthesia. Postoperative delirium was assessed twice daily for 7 days using the CAM by trained, blinded assessors.

Inclusion Criteria: Patients of both genders having age 60-90 years .Patients undergoing for elective surgery under general anesthesia American society of Anesthesiology I-III Exclusion criteria: Patients with Preoperative delirium, History of dementia ,Psychiatric disease like schizophrenia, epilepsy, Parkinson's disease or myasthenia gravis ,Hepatic or renal dysfunction ,Requirement for postoperative mechanical ventilation ,History of surgery within the recent six months ,Allergy to any of the study drugs

Group A patients will receive sevoflurane based anesthesia while Group-B patients will receive propofol based anesthesia

The primary outcome variable is the incidence of postoperative delirium within 7 days after surgery, assessed using the Confusion Assessment Method. Delirium is recorded as a binary outcome (Yes/No) based on CAM diagnostic criteria during twice-daily evaluations

This study was designed as a randomized controlled trial (RCT) to compare the incidence of post-operative delirium (POD) in geriatric patients undergoing surgery under general anesthesia with either propofol or sevoflurane. Eligible participants were randomly assigned to one of two groups: Group A received propofol-based general anesthesia, while Group B received sevoflurane-based general anesthesia. Randomization was performed using a computer-generated sequence to ensure equal and unbiased allocation, with allocation concealment maintained to minimize selection bias. Post-operatively, all patients were closely monitored for signs of delirium using a validated assessment tool, such as the Confusion Assessment Method (CAM). The primary outcome measured was the incidence of POD within 72 hours after surgery. This randomized design enabled a direct and unbiased comparison of the effects of propofol and sevoflurane on the development of post-operative delirium in older surgical patients.

This study was designed as a single-blinded randomized controlled trial (RCT) to compare the incidence of post-operative delirium (POD) in geriatric patients undergoing surgery under general anesthesia with either propofol or sevoflurane. Eligible participants were randomly assigned to one of two groups: Group A received propofol-based general anesthesia, while Group B received sevoflurane-based general anesthesia. Randomization was performed using a computer-generated sequence to ensure equal and unbiased allocation, with allocation concealment maintained to minimize selection bias. In this single-blinded design, patients were unaware of the type of anesthesia they received, while the anesthesia providers were informed due to the nature of drug administration. Post-operatively, all patients were closely monitored for signs of delirium using a validated assessment tool, such as the Confusion Assessment Method (CAM). The primary outcome measured was the incidence of POD within 72 hours after surgery. This randomized and blinded design allowed for a more objective and unbiased comparison of the effects of propofol and sevoflurane on the development of post-operative delirium in older surgical patients.

There is currently no plan to make deidentified individual participant data (IPD) available due to concerns regarding patient privacy, lack of infrastructure for secure data sharing, or institutional restrictions.

Title: A Comparative Analysis of Post-Operative Delirium Incidence: Sevoflurane vs. Propofol in Geriatric Patients Under General Anesthesia Details: This dataset comprises anonymized clinical trial data collected from 200 patients aged 60–90 years undergoing elective surgery under general anesthesia. It includes demographic information, anesthesia type, ASA status, comorbidities, surgery type, and Confusion Assessment Method (CAM) scores collected over seven postoperative days. Documents Included: Full Study Protocol (as above) Completed CRFs/Proforma (de-identified) CAM Scoring Logs Statistical Analysis Output (SPSS) Informed Consent Form Template Ethics Committee Approval Letter

Availability: The data will become available six months post-study completion, anticipated to be by March 2026. Retention Period: The data and associated documents will be accessible for at least 5 years following publication (i.e., until March 2031), with possibility of extended availability based on public or institutional interest

Access will be granted to: Researchers affiliated with recognized academic or clinical institutions Public health policy makers Graduate or postgraduate medical/anesthesia students Ethics-approved independent researchers

Data use is contingent on: Purpose: Non-commercial, research and educational use only Signing of a Data Use Agreement (DUA) detailing: Prohibition of re-identification attempts Use of data strictly for the approved project Proper citation of original study IRB/Ethical Review approval from the applicant’s institution (if applicable)

Documents and datasets will be obtainable through the following channels: Primary contact: Principal Investigator (Dr. [Insert Name], Allied Hospital, Faisalabad) Institutional Repository: University of Health Sciences or affiliated hospital server (TBD) Publication Supplementary Material: Upon journal article acceptance and publication (journal TBD) Email request: irslan3310@gmail.com

Initial Inquiry: Interested parties contact the Principal Investigator via email or institutional contact form. Submission of Request Form: Researchers complete a Data Request Form outlining: Affiliation Study objectives Ethical clearance documentation (if applicable) Duration of intended data use Review by Data Access Committee (DAC): Applications will be evaluated within 15 working days. Data Use Agreement (DUA): Approved users must sign the DUA before receiving access credentials or files. Data Delivery: Data shared via encrypted institutional cloud storage or secure USB handover (if local). Follow-Up Reporting: Users agree to provide a summary or citation of how the data was used (e.g., in publications, presentations, or theses)