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IRCT20260714070195N1 IRCT 2026-10-19 Ilam University of Medical Sciences Comparison of the Effect of Propofol Anesthesia (TIVA) versus Isoflurane on the Incidence of Postoperative Delirium Based on Sex Differences in Adults Undergoing Abdominal Surgery TIGER-ED Comparison of the effects of total intravenous anesthesia ( TIVA with propofol) versus inhalational anesthesia (Isufluran) on the incidence of emergence delirium based on gender differences in adults undergoing abdominal surjeries 2026-10-23 anticipated 200 Recruiting https://irct.ir/trial/92196 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: None, Randomization description: Randomization method: Balanced Block Randomization Randomization unit: Individual (each patient is randomized separately) Stratification factors: No stratification is used in this study. Randomization tool: Random number table Sequence generation: Blocks with different permutations including (ABBA, ABAB, AABB, BBAA, BABA, BAAB) are created, where A represents the TIVA with propofol group and B represents the isoflurane group. Then, based on a random number table, the allocation sequence is determined to maintain group balance and blinding. Allocation concealment: The study drugs (propofol solution and isoflurane liquid) are prepared in identical containers without any label indicating the group and are provided to the anesthesiologist. Only the principal investigator has access to the randomization codes, Blinding description: This study uses a double-blind design. Blinding is implemented as follows: 1. Participants (Patients): Patients receive complete information about the study one day before surgery but are unaware of the type of anesthesia method assigned to them. 2. Anesthesiologist (Intervention provider): Although the anesthesiologist is aware of the administered drug, all drugs are prepared in identical containers without any group-identifying labels to minimize selection bias. 3. Surgeon: The surgeon is blinded to the anesthesia method. 4. Recovery room nurses (Clinical caregivers): Nurses responsible for patient care and assessment in the post-anesthesia care unit (PACU) are blinded to the group allocation. 5. Outcome assessors: Trained nurses who administer the CAM-ICU and CAM questionnaires for delirium assessment are completely blinded to the patients' group allocation. 6. Principal investigator: The principal investigator has access to the randomization codes but is not involved in outcome assessment. However, the codes will be used for final data analysis. 7. Data analyst: The individual performing statistical analysis is blinded to group allocation to prevent bias in data interpretation. 8. Allocation concealment: Study drugs (propofol solution and isoflurane liquid) are prepared in identical containers without any group-identifying labels and are provided to the anesthesiologist. Only the principal investigator has access to the randomization codes and is not involved in drug administration. 3 Delirium. Intervention 1: In this group, Total Intravenous Anesthesia (TIVA) is performed using Propofol. The induction dose of Propofol is administered intravenously at [exact number] mg/kg. For maintenance of anesthesia, a continuous infusion of Propofol is set at [exact number] mcg/kg/min. Propofol manufactured by [Company Name], with a concentration of 1% (10 mg/ml), will be used. Intervention 2: In this group, inhalation anesthesia is performed using Isoflurane. Induction of anesthesia is performed via a face mask or after tracheal intubation. Isoflurane is administered to the patient through the anesthesia machine at a concentration of [exact number] MAC. For maintenance of anesthesia, the Isoflurane concentration is set at [100]%. Isoflurane manufactured by [Abbott India limited], with a concentration of [100%], will be used. Yes - There is a plan to make this available What will be shared: Individual Participant Data (IPD) from a randomized clinical trial comparing TIVA with propofol versus isoflurane on emergence delirium in abdominal surgery When: Data will be available after publication of the main results (expected 12 months after study completion) and will remain accessible for 5 years. To whom: Qualified researchers from academic institutions with a valid research proposal and ethics approval, upon reasonable request to the corresponding author (Atieh Zolfaghari, zola69440@gmail.com) Conditions: The de-identified IPD and supporting documents (protocol, SAP, data dictionary) may be used exclusively for: (1) secondary analyses related to postoperative cognitive outcomes, delirium, or anesthetic techniques; (2) systematic reviews and meta-analyses; (3) methodological validation or replication studies. Users must not use the data for commercial purposes, must maintain confidentiality, and must cite the original study in any resulting publications. Any secondary analysis must be approved by the corresponding author and the ethics committee of the user's institution. Where to obtain: Requests for data and supporting documents should be directed to the corresponding author: Atieh Zolfaghari, Department of Anesthesiology, Ilam University of Medical Sciences, Ilam, Iran. Email: zola69440@gmail.com. Postal address: Ilam University of Medical Sciences, Ilam, Iran. Telephone: +98-9964871066. How to obtain: The request process includes the following steps: (1) The applicant submits a formal request via email to the corresponding author, including a brief research proposal, intended analysis plan, and ethics approval from their institution. (2) The request is reviewed by the research team for scientific validity and ethical compliance. (3) If approved, the applicant signs a data-sharing agreement ensuring confidentiality, non-commercial use, and proper citation. (4) The de-identified data and relevant documents are shared via a secure online repository (e.g., Zenodo or Figshare) with a password-protected link. The entire process is expected to take approximately 2-4 weeks. Comments: This study is registered in the Iranian Registry of Clinical Trials (IRCT). The full protocol and SAP are available as supplementary materials in the main publication. Any publications using these data should cite the primary study and acknowledge the funding source (Ilam University of Medical Sciences).
public Atiyeh zolfaghari
Salman farsi st
Eyvan Iran (Islamic Republic of) 6941914485 +98 84 3323 3855 zola69440@gmail.com Ilam University of Medical Sciences scientific Atiyeh zolfaghari
Salman farsi st
Eyvan Iran (Islamic Republic of) 6941914485 +98 84 3323 3855 zola69440@gmail.com Ilam University of Medical Sciences Iran (Islamic Republic of) Age between 18 to 65 years Undergoing abdominal surgery with general Anesthesia ASA physical status class I or II 18 years 65 years Both History of serious psychiatric illness Pre-existing cognitive disorders Hepatic or renal failure Substance abuse Hypersensitivity to study drugs (propofol, isoflurane, etc.) Pregnancy or lactation Treatment - Drugs Treatment - Drugs In this group, Total Intravenous Anesthesia (TIVA) is performed using Propofol. The induction dose of Propofol is administered intravenously at [exact number] mg/kg. For maintenance of anesthesia, a continuous infusion of Propofol is set at [exact number] mcg/kg/min. Propofol manufactured by [Company Name], with a concentration of 1% (10 mg/ml), will be used. In this group, inhalation anesthesia is performed using Isoflurane. Induction of anesthesia is performed via a face mask or after tracheal intubation. Isoflurane is administered to the patient through the anesthesia machine at a concentration of [exact number] MAC. For maintenance of anesthesia, the Isoflurane concentration is set at [100]%. Isoflurane manufactured by [Abbott India limited], with a concentration of [100%], will be used. Incidence of postoperative delirium (POD) diagnosed using the standardized NUDESC (Nursing Delirium Screening Scale) at multiple time points including the PACU period, as well as 6 and 12 hours after surgery. This tool consists of 5 key items assessing the presence or absence of delirium symptoms. The total score ranges from 0 to 5, and a score of 2 or higher (NUDESC ≥ 2) is considered a positive diagnosis of delirium. Timepoint: Delirium assessment using the NUDESC tool is performed at five time points:1. Upon admission to the PACU (immediately after transfer from the operating room)2. 30 minutes after PACU admission3. At the time of PACU discharge (when discharge criteria are met)4. 6 hours after surgery (in the ward)5. 12 hours after surgery (in the ward). Method of measurement: Assessment is performed by trained and blinded nurses using the standardized NUDESC tool. The nurse, through direct patient observation, medical record review, and interview with the patient's companion (if necessary), evaluates the presence or absence of each of the following 5 signs:1. Disorientation2. Inappropriate behavior3. Inappropriate communication4. Hallucination/Delusion5. Psychomotor retardation/agitationEach sign scores 1 point, and the total score ranges from 0 to 5. A score of ≥ 2 is considered a positive diagnosis of delirium.Simultaneously with delirium assessment at these time points, hemodynamic parameters including Mean Arterial Pressure (MAP), Heart Rate (HR), and Arterial Oxygen Saturation (SpO₂) are also recorded and evaluated to assess the relationship between hemodynamic changes and the occurrence of delirium. Ilam University of Medical Sciences Approved 2026-07-14 Ilam University of Medical Sciences Research Ethics Committee Salman farsi st Eyvan Ilam Iran (Islamic Republic of)