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IRCT20250524065864N1 IRCT 2025-05-27 Faisalabad medical university Comparing the risk of post-surgery delirium in older adults: sevoflurane vs propofol anesthesia The comparative analysis of post-operative delirium incidence: sevoflurane vs propofol in geriatric patients under general anaesthesia 2024-12-05 anticipated 200 Complete https://irct.ir/trial/83767 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Length of hospital stay, Severity and duration of Post Op delirium, Randomization description: 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, Blinding description: 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. 2 Post-operative delirium (POD) is a common and serious complication that occurs after surgery, particularly in older adults. It is characterized by an acute and fluctuating disturbance in attention, awareness, and cognition, typically arising within the first few days following anesthesia and surgery. POD can manifest as confusion, disorientation, memory disturbances, hallucinations, or agitation, and may vary in intensity and duration. It is associated with increased morbidity, prolonged hospital stays, higher healthcare costs, and a greater risk of long-term cognitive decline or institutionalization. Various factors contribute to the development of POD, including advanced age, pre-existing cognitive impairment, type of surgery, and the choice of anesthetic agents. Early detection and appropriate management are essential to improving patient outcomes and minimizing the impact of this condition.. Intervention 1: Intervention group: Group A received sevoflurane-based anesthesia, while Group B received propofol-based anesthesia. All participants were induced with intravenous propofol (1–2 mg/kg), nalbuphine (0.1–0.2 mg/kg), and atracurium (0.5 mg/kg).Anesthesia in Group A was maintained using inhaled sevoflurane, titrated to achieve a BIS value between 40 and 60. Intervention 2: Intervention group: Group B received target-controlled infusion (TCI) of propofol to maintain a BIS value within the same range. Muscle relaxation in both groups was maintained with continuous atracurium infusion (10 μg/kg/min). No - There is not a plan to make this available Justification or reason for not sharing IPD is 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.
public Dr Humaira Ahmad
Masjid Ismail Rd, Faisalabad
Faisalabad Pakistan 38000 +92 333 5824895 Humaira_ahmad21@hotmail.com Allied Hospital faisalabad scientific Dr Ammara Liaqat
Masjid Ismail Rd, Faisalabad
Faisalabad Pakistan 38000 +92 332 1752600 Ammaraliaqat22@gmail.com Allied Hospital Faisalabad Pakistan Both gender 60-90 Patients undergoing for Mild to moderate risk elective surgery American society of Anesthesiology (ASA) I-III 60 years 90 years Both Patient 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 Allergy to any of the study drugs History of surgery within the recent six months F05.8 Post-operative delirium (POD) is a common and serious complication that occurs after surgery, particularly in older adults. It is characterized by an acute and fluctuating disturbance in attention, awareness, and cognition, typically arising within the fi Treatment - Drugs Treatment - Drugs Intervention group: Group A received sevoflurane-based anesthesia, while Group B received propofol-based anesthesia. All participants were induced with intravenous propofol (1–2 mg/kg), nalbuphine (0.1–0.2 mg/kg), and atracurium (0.5 mg/kg).Anesthesia in Group A was maintained using inhaled sevoflurane, titrated to achieve a BIS value between 40 and 60. Intervention group: Group B received target-controlled infusion (TCI) of propofol to maintain a BIS value within the same range. Muscle relaxation in both groups was maintained with continuous atracurium infusion (10 μg/kg/min) Post Operative Delirium. Timepoint: During the first seven post-operative days, delirium will be assessed twice each day, that is, between 8–10 am and 6–8 pm, by using CAM. Delirium will be assessed as per operational definition. All the information will be recorded on performa by myself. Method of measurement: Confusion Assessment Method. Reduce hospital stay and better outcomes. Timepoint: During the first seven post-operative days, delirium will be assessed twice each day, that is, between 8–10 am and 6–8 pm, by using CAM. Method of measurement: Confusion Assessment Method (CAM). Faisalabad medical university Approved 2024-12-05 Secretariat Ethical Review Committee National lnstitute of Heatth, Research Centre Ground Floor Anatomy Department Faisalabad medical university Faisalabad Faisalabad Punjab Pakistan