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IRCT20240221061070N5 IRCT 2025-04-26 Esfahan University of Medical Sciences Comparison of the Effect of Intravenous Paracetamol and Intrathecal Meperidine on Shivering After Spinal Anesthesia A Comparative Study on the Effect of Intravenous Paracetamol and Intrathecal Meperidine on Shivering in Patients Undergoing Cesarean Section with Spinal Anesthesia 2025-04-28 anticipated 90 Complete https://irct.ir/trial/78186 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, simple randomization will be used to allocate participants into three groups (Group A, Group B, and Group C). This method ensures that each eligible patient has an equal and independent chance of being assigned to any of the groups, thereby minimizing selection bias. The unit of randomization in this study is individual; that is, each patient will be independently and separately assigned to one of the groups. The randomization tool used is the Sequence Generator available on the website www.random.org. In this tool, a random sequence of numbers from 1 to 15 is generated and equally distributed among the three groups A, B, and C. Each number from 1 to 15 is assigned to one of the groups, and the order of these numbers in the list determines the group assignment of the patients. For example, if number 7 appears in the column for Group C, the seventh eligible patient will be assigned to Group C. This process will be repeated for every set of 15 patients. That is, after completing the allocation for the first 15 patients, a new random sequence will be generated for the next 15 patients. This process will continue until the desired sample size is reached. Allocation concealment will be ensured through the use of opaque, sealed, and sequentially numbered envelopes. The generated randomization sequence will be kept confidential within these envelopes. Each envelope will be opened only after confirming the patient's eligibility and obtaining written informed consent. The envelopes will be prepared and maintained by an independent researcher who is not involved in patient recruitment or data collection, in order to prevent any potential allocation bias, Blinding description: In this study, to minimize bias and enhance the accuracy of outcome measurement, blinding will be implemented comprehensively and at multiple levels. The following individuals will remain blinded to the group allocation of patients throughout the study process: Participants (Patients): All patients enrolled in the study will be unaware of the type of drug administered and their respective treatment group. Additionally, they will not be informed about the allocation of other participants to different groups. It is important to emphasize that all patients will sign a written informed consent form prior to participation and will be fully aware of their involvement in a clinical trial. Therefore, the blinding process will in no way violate ethical principles and will be conducted in full accordance with ethical guidelines. Medical Personnel (Physicians, Anesthesiologists, Surgeons, and Nurses): The study drugs for all groups will be prepared in advance by the principal investigator in identical, unlabeled syringes. These syringes will be delivered to a nursing staff member who has no knowledge of the group allocation or the nature of the drugs. A fully independent anesthesiologist, who is not involved in any part of the study design, implementation, or data analysis and is completely blinded to the type of drug administered and the treatment group of the patients, will be responsible for performing the intrathecal injection. Researchers and Study Team: Researchers responsible for data collection, documentation, and patient follow-up—including anesthesia residents—will be blinded to the type of drug administered and the patients' treatment groups. These individuals will not be involved in the study design, patient allocation, or drug administration, and their role will be limited to recording the outcomes. Outcome Assessors: All assessments of primary and secondary outcomes will be conducted by individuals who are blinded to the treatment groups. These assessors will have no knowledge of the specific interventions received by the patients and will document outcomes solely based on predefined criteria. Data Analysts: Statistical analysis of the data will be performed by an individual who has access only to the group codes (A, B, C) but is unaware of the actual interventions corresponding to each group. Final unblinding will occur only after the completion of the statistical analysis and confirmation of the results. Manuscript Authors: The authors responsible for drafting the manuscript will also remain blinded to the group allocation until the final stage of data analysis and unblinding. This measure is intended to preserve objectivity in the interpretation of the findings. 3 Shivering after Cesarean section under spinal anesthesia. Intervention 1: Intervention group: In the intravenous paracetamol group, each patient will receive 1 gram of paracetamol diluted in 100 mL of normal saline, administered intravenously over 15 minutes. The paracetamol used is in injectable form, commercially available as Apotel manufactured by UNI-PHARMA, or a generic equivalent approved by the Ministry of Health. Intervention 2: Intervention group: In the intrathecal meperidine group, each patient will receive meperidine at a dose of 0.1 mg/kg body weight via intrathecal injection. Following the spinal injection, the patient will also receive 100 mL of intravenous normal saline over 15 minutes, similar to other groups. The meperidine used is in injectable form (Meperidine HCl), commercially available as ALODAN manufactured by G.L.Pharma GmbH, or a generic equivalent approved by the Ministry of Health. Intervention 3: Control group: Each patient in the control group will receive 100 mL of intravenous normal saline over a period of 15 minutes. This solution contains no active pharmaceutical ingredients and serves as a placebo. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no additional information available.
public Milad Masaeli
Shahid Beheshti Hospital, opposite Asman Hotel, Beginning of Shahid Motahari St.
Isfahan Iran (Islamic Republic of) 81848-53541 +98 81 8485 3541 drmilmas@gmail.com Esfahan University of Medical Sciences scientific Milad Masaeli
Shahid Beheshti Hospital, opposite Asman Hotel, Beginning of Shahid Motahari St.
Isfahan Iran (Islamic Republic of) 81848-53541 +98 31 3236 7001 drmilmas@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients who are candidates for spinal anesthesia in elective cesarean section ASA class I and II Age between 18 and 45 years 18 years 45 years Female Patients with systemic infections or infections at the site of spinal block Patients with thyroid disorders Patients with cardiovascular or pulmonary diseases Individuals with coagulation disorders Patients with neurological impairments Individuals with psychiatric disorders Patients with a known history of alcohol dependence or substance abuse Body Mass Index greater than 35 Baseline body temperature above 38°C or below 36.5°C, or those receiving vasodilator medications or drugs that interfere with thermoregulation Known history of hypersensitivity to paracetamol or meperidine O74.9 Complication of anesthesia during labor and delivery, unspecified Treatment - Drugs Treatment - Drugs Placebo Intervention group: In the intravenous paracetamol group, each patient will receive 1 gram of paracetamol diluted in 100 mL of normal saline, administered intravenously over 15 minutes. The paracetamol used is in injectable form, commercially available as Apotel manufactured by UNI-PHARMA, or a generic equivalent approved by the Ministry of Health. Intervention group: In the intrathecal meperidine group, each patient will receive meperidine at a dose of 0.1 mg/kg body weight via intrathecal injection. Following the spinal injection, the patient will also receive 100 mL of intravenous normal saline over 15 minutes, similar to other groups. The meperidine used is in injectable form (Meperidine HCl), commercially available as ALODAN manufactured by G.L.Pharma GmbH, or a generic equivalent approved by the Ministry of Health. Control group: Each patient in the control group will receive 100 mL of intravenous normal saline over a period of 15 minutes. This solution contains no active pharmaceutical ingredients and serves as a placebo. Incidence of shivering after spinal anesthesia. Timepoint: 5, 10, 15, 30, 60, and 90 minutes after spinal anesthesia. Method of measurement: Observation and patient inquiry. Severity of shivering after spinal anesthesia. Timepoint: 5, 10, 15, 30, 60, and 90 minutes after spinal anesthesia. Method of measurement: Bedside Shivering Assessment Scale (BSAS). Heart rate. Timepoint: 5, 10, 15, 30, 60, and 90 minutes after spinal anesthesia. Method of measurement: Vital signs monitoring device. Central temperature. Timepoint: 5, 10, 15, 30, 60, and 90 minutes after spinal anesthesia. Method of measurement: Core temperature assessment using a standard tympanic thermometer through the external auditory canal. Peripheral temperature. Timepoint: 5, 10, 15, 30, 60, and 90 minutes after spinal anesthesia. Method of measurement: Axillary temperature measurement using a standard mercury thermometer. Level of sedation in patients following spinal anesthesia. Timepoint: Every 15 minutes from the initiation of spinal anesthesia up to 90 minutes post-procedure. Method of measurement: Richmond Agitation-Sedation Scale (RASS). Patient satisfaction with the spinal anesthesia procedure. Timepoint: 90 minutes after the initiation of spinal anesthesia. Method of measurement: 7-point verbal Likert scale. Esfahan University of Medical Sciences Approved 2024-02-21 Ethics Committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences and Health Services, Hazar Jarib St. Isfahan Isfehan Iran (Islamic Republic of)