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IRCT20260803070523N1 IRCT 2026-10-28 Ilam University of Medical Sciences Comparison of Two Anesthesia Methods on Myoclonic Movements in Abdominal Surgery PIMA Ratio of the Effects of Total Intravenous Anesthesia TIVA with Propofol versus Inhalation Anesthesia Isoflurane on the incidence of Myoclonic Movements Based on Gender Differences in Adults Undergoing Abdominal Surgery 2026-10-23 anticipated 182 Recruiting https://irct.ir/trial/92679 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: None, Randomization description: After obtaining informed consent, eligible patients will be randomly allocated into two equal groups (91 patients per group) using block randomization with block sizes of 4. The allocation ratio is 1:1. Randomization codes will be generated by the principal investigator and sealed in opaque, unlabeled envelopes. The envelopes will be opened immediately before the induction of anesthesia by the attending anesthesiologist who is not involved in the randomization process. The principal investigator is aware of the allocation process but is not involved in outcome assessment or data collection. The unit of randomization is the individual patient, Blinding description: In this double-blind randomized clinical trial, three main groups are masked to the treatment allocation: 1. Participants (Patients): Patients receive comprehensive information about the study objectives, procedures, and potential complications one day before surgery, but they remain unaware of the type of anesthesia maintenance method assigned to them (TIVA with propofol versus isoflurane inhalation anesthesia). 2. Clinical Caregivers (except the attending anesthesiologist): Operating room nurses, anesthesia assistants, and recovery room personnel are unaware of the intervention type. Anesthesia drugs are prepared in identical containers without identifying labels and are provided to the anesthesiologist. Only the attending anesthesiologist who administers the drugs is aware of the intervention but is not involved in outcome assessment. 3. Outcome Assessor: A trained research observer who is responsible for evaluating and recording myoclonic movements and hemodynamic parameters during surgery and in the recovery room is completely blinded to the group allocation and has no knowledge of the anesthesia method received by each patient. This assessor is independent of the clinical care team. Other groups: · Attending Anesthesiologist: Is aware of the intervention type as they must administer the assigned drug (propofol or isoflurane), but they are not involved in outcome assessment. · Principal Investigator: Has access to the randomization codes and group assignments but is not involved in drug administration or outcome evaluation. · Data Analyst: Analyzes data based on group allocation and is therefore not blinded. 3 Myoclonus. 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: Control group: 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 us. Yes - There is a plan to make this available What will be shared: IPD (Individual Participant Data): Anonymized individual participant data including demographic information, hemodynamic parameters, incidence and severity of myoclonic movements, total anesthetic drug dosage, length of stay in recovery, and Aldrete scores. All data will be shared after removing identifiable information (name, national ID, medical record number). Study Protocol: Full study protocol including objectives, methods, inclusion and exclusion criteria, interventions, outcomes, statistical analysis plan, and ethical considerations. Statistical Analysis Plan (SAP): Detailed statistical methods including tests to be used, management of missing data, adjustment methods for confounding variables, and Intention-to-Treat approach. Informed Consent Form: Written informed consent form approved by the ethics committee, containing complete explanations for patients regarding objectives, methods, potential complications, and participants' rights. When: Access to data and documents will be available starting 12 months after publication of the main study results and will continue for 5 years. To whom: Qualified researchers who provide a reasonable and well-justified request for data access. Access will be granted upon approval by the principal research team and with full compliance with patient data confidentiality requirements. Conditions: Data may be used solely for research and scientific purposes such as meta-analysis, secondary analyses, or replication of results. Any use of the data must be accompanied by proper citation of the original study. Commercial use or redistribution of data without permission from the research team is prohibited. All users are required to maintain the confidentiality of participant information. Where to obtain: For access to study data and documents, please contact the Principal Investigator, Ms. Fatemeh Rostami, via the following email: Email: fa.rostamiii1382@gmail.com Mobile: +98 9960758982 If no response is received, you may also contact the Vice-Chancellery for Research and Technology, Ilam University of Medical Sciences: Address: Vice-Chancellery for Research and Technology, Ilam University of Medical Sciences, Farhang Street, Ilam, Iran How to obtain: Applicants must first submit a written request along with a detailed description of the purpose of using the data and documents to the principal investigator's email. The request will be reviewed by the main research team. Upon approval, the applicant will be required to sign a confidentiality agreement and a non-commercial use commitment. After these steps, anonymized data will be provided in Excel or SPSS format. The entire process will be completed within a maximum of 2 to 4 weeks after submission of the request. Comments:
public Fatemeh Rostami
No. 62, Shahid Rajaei Street, Opposite the Governor's Office,
Islam Abad Gharb Iran (Islamic Republic of) ۶۷۶۱۸۳۳۴۳۹ +98 83 4522 7035 fa.rostamiii1382@gmail.com Ilam University of Medical Sciences scientific Fatemeh Rostami
No. 62, Shahid Rajaei Street, Opposite the Governor's Office,
Islam Abad Gharb Iran (Islamic Republic of) ۶۷۶۱۸۳۳۴۳۹ +98 83 4522 7035 fa.rostamiii1382@gmail.com Ilam University of Medical Sciences Iran (Islamic Republic of) Undergoing abdominal surgery under general anesthesia Age between 18 and 65 years ASA physical status class I or II 18 years 65 years Both History of neurological or neuromuscular disorders (epilepsy, myoclonus, myasthenia gravis) Use of medications affecting the central nervous system in the past week (benzodiazepines, antidepressants, antipsychotics) Known hypersensitivity to propofol or isoflurane Cognitive or psychiatric disorders that may interfere with proper evaluation or cooperation with the treatment team Pregnancy or breastfeeding 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. Control group: 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 us Incidence of any sudden, brief, involuntary, and jerky muscle contractions (myoclonic movements), recorded as a binary event (Yes/No). Timepoint: Continuously from the induction of anesthesia until the end of surgery (every 15 minutes by a research observer in the operating room). Method of measurement: Direct observation and recording of movements by a trained research observer who is blinded to the patient's group allocation. Ilam University of Medical Sciences Approved 2026-06-23 Ilam University of Medical Sciences Research Ethics Committee Eslamabad-e Gharb Opposite the Governor's Office, Rajaei St., No. 62 Islam Abad Gharb Kermanshah Iran (Islamic Republic of)