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IRCT20210222050463N10 IRCT 2026-09-16 Ahvaz University of Medical Sciences Warmed IV Fluids to Prevent Low Blood Pressure During Spinal Anesthesia in Elderly Patients with High Blood Pressure Undergoing Orthopedic Surgery Effect of Warmed versus Room-Temperature Intravenous Fluid Co-loading on Spinal Anesthesia-Induced Hypotension in Elderly Hypertensive Patients Undergoing Orthopedic Surgery 2026-10-01 anticipated 70 Recruiting https://irct.ir/trial/93273 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Method of randomization: Block randomization with a fixed block size determined by the statistician. Unit of randomization: Individual participants. Randomization strata: No stratification was used. Tools used for randomization: Random Allocation software (or a random number table) and sequentially numbered, opaque, sealed envelopes. How the random sequence was built: The randomization sequence was generated in advance by a statistician who was not involved in participant enrollment or data collection. Block randomization was used to ensure balance between the two study groups. Allocation concealment: Yes. The generated allocation sequence was placed in sequentially numbered, opaque, sealed envelopes. These envelopes were opened in order by a research assistant who was not involved in data collection or outcome assessment. The envelopes were opened only after the participant had been enrolled and written informed consent had been obtained, Blinding description: Participants, the attending anesthesiologist (care provider), the investigator, the outcome assessor, and the data analyst are blinded to group allocation. The intravenous fluids are prepared and coded by a nurse who is not involved in data collection or outcome assessment. The fluid bags and infusion tubing are covered with opaque insulating materials to prevent identification of fluid temperature. Only the nurse responsible for preparing the study fluids is aware of the intervention assignment. The allocation codes are kept confidential until completion of data collection and statistical analysis. The Data and Safety Monitoring Board is not involved in this study. N/A Spinal anesthesia-induced hypotension in elderly patients. Intervention 1: Intervention group: Warmed intravenous fluid group. Participants receive Ringer's lactate solution (manufactured by Shahid Ghazi Pharmaceutical Co.) warmed to 37-38 degrees Celsius using a BIEGLER BW 685 standard intravenous fluid warming device. The fluid is administered as co-loading immediately after intrathecal injection and establishment of spinal anesthesia. The volume is 10-15 milliliters per kilogram of body weight during the first 15-20 minutes, followed by maintenance fluid at 2-4 milliliters per kilogram per hour. Intervention 2: Control group: Room-temperature intravenous fluid group. Participants receive the same Ringer's lactate solution (manufactured by Shahid Ghazi Pharmaceutical Co.) at operating room temperature, approximately 20-24 degrees Celsius. The fluid is administered as co-loading immediately after intrathecal injection and establishment of spinal anesthesia. The volume is 10-15 milliliters per kilogram of body weight during the first 15-20 minutes, followed by maintenance fluid at 2-4 milliliters per kilogram per hour. Yes - There is a plan to make this available What will be shared: Deidentified individual participant data (IPD), data dictionary, study protocol, statistical analysis plan, and informed consent form. The IPD set includes all collected data on demographics, clinical characteristics, hemodynamic parameters (systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, oxygen saturation), incidence and number of hypotensive episodes, time to first hypotensive episode, vasopressor dose and frequency, and patient satisfaction and comfort scores. All data will be deidentified before sharing. The data dictionary will contain variable names, definitions, coding, and units. The study protocol describes the full methods. The statistical analysis plan describes the planned analyses. The informed consent form is the version approved by the ethics committee. When: Data will become available 6 months after publication of the primary results and will remain available for 5 years. To whom: Researchers working in academic institutions, research centers, or healthcare organizations. Applicants from the industry may also apply if they provide a methodologically sound proposal. Conditions: Data will be shared for secondary analyses that are methodologically sound and approved by the principal investigator. Requests must include a written proposal describing the research question, analysis plan, and intended use. A signed data access agreement is required. Data may not be used for commercial purposes or to re-identify participants. Requests will be reviewed by the principal investigator and the research team.Data will be shared for secondary analyses that are methodologically sound and approved by the principal investigator. Requests must include a written proposal describing the research question, analysis plan, and intended use. A signed data access agreement is required. Data may not be used for commercial purposes or to re-identify participants. Requests will be reviewed by the principal investigator and the research team. Where to obtain: Data and documents are obtainable by contacting the principal investigator: Dr. Ali Khalafi Department of Anesthesia Technology, School of Paramedical Sciences, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Email: khalafi-a@ajums.ac.ir Telephone: 09163359407 How to obtain: Applicants should send a written request by email to the principal investigator, including a brief research proposal, the intended analysis plan, and the institutional affiliation. The request will be reviewed by the principal investigator and the research team within 4 weeks. If approved, a data access agreement will be sent to the applicant for signature. After the signed agreement is received, the deidentified data and requested documents will be transferred electronically within 2 weeks. The entire process is expected to take approximately 6 to 8 weeks. Comments:
public Nooshin Sarvi-Sarmeydani
School of Paramedicine, Anesthesiology Department, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd., Ahvaz
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3333 0011 nooshinsarvi9192@gmail.com Ahvaz University of Medical Sciences scientific Nooshin Sarvi-Sarmeydani
School of Paramedicine, Anesthesiology Department, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd., Ahvaz
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3333 0011 nooshinsarvi9192@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Age 65 years or older. Diagnosis of hypertension with regular use of antihypertensive medications. American Society of Anesthesiologists (ASA) physical status II or III. Candidate for elective lower limb orthopedic surgery (hip or knee) under spinal anesthesia. Absence of significant valvular heart disease, severe heart failure, significant arrhythmias, or recent myocardial infarction. Willingness to participate and provision of written informed consent. 65 years no limit Both Severe hyperkalemia. Severe hepatic impairment. Lactic acidosis. Inability to cooperate or complete questionnaires/assessments due to cognitive or communication impairment. I95.9 Hypotension, unspecified Prevention Prevention Intervention group: Warmed intravenous fluid group. Participants receive Ringer's lactate solution (manufactured by Shahid Ghazi Pharmaceutical Co.) warmed to 37-38 degrees Celsius using a BIEGLER BW 685 standard intravenous fluid warming device. The fluid is administered as co-loading immediately after intrathecal injection and establishment of spinal anesthesia. The volume is 10-15 milliliters per kilogram of body weight during the first 15-20 minutes, followed by maintenance fluid at 2-4 milliliters per kilogram per hour. Control group: Room-temperature intravenous fluid group. Participants receive the same Ringer's lactate solution (manufactured by Shahid Ghazi Pharmaceutical Co.) at operating room temperature, approximately 20-24 degrees Celsius. The fluid is administered as co-loading immediately after intrathecal injection and establishment of spinal anesthesia. The volume is 10-15 milliliters per kilogram of body weight during the first 15-20 minutes, followed by maintenance fluid at 2-4 milliliters per kilogram per hour. Incidence of spinal anesthesia-induced hypotension, defined as a decrease in systolic blood pressure of 20 percent or more from baseline or a decrease in systolic blood pressure to less than 90 millimeters of mercury, whichever occurs first. Timepoint: From the time of spinal block placement up to 45 minutes after the block. Method of measurement: Non-invasive blood pressure monitoring using an automated oscillometric blood pressure device. Blood pressure is measured at baseline and then every 2 to 4 minutes during the first 20 minutes after spinal block, and every 15 minutes thereafter until 60 minutes after the block or until the end of surgery. Total number of hypotensive episodes, defined as a decrease in systolic blood pressure of 20 percent or more from baseline or a decrease in systolic blood pressure to less than 90 millimeters of mercury, whichever occurs first. Timepoint: From the time of spinal block placement until 60 minutes after the block or until the end of surgery. Method of measurement: Non-invasive blood pressure monitoring using an automated oscillometric blood pressure device, recorded every 2 to 4 minutes during the first 20 minutes after spinal block and every 15 minutes thereafter. Time in minutes from spinal block placement to the first occurrence of hypotension. Timepoint: From the time of spinal block placement until the first hypotensive episode or up to 45 minutes after the block. Method of measurement: Recording the time from intrathecal injection to the first hypotensive reading, using a stopwatch and non-invasive blood pressure monitoring. Total dose of vasopressor administered to treat hypotension, including ephedrine or phenylephrine. Timepoint: During surgery, from spinal block placement until the end of surgery. Method of measurement: Recording the type, dose, frequency, and timing of vasopressor administration from the anesthesia record. Patient satisfaction score with anesthesia and surgery, measured using a Likert scale questionnaire. Timepoint: In the post-anesthesia care unit after surgery. Method of measurement: A short patient satisfaction questionnaire with Likert scale responses. Patient comfort score in the post-anesthesia care unit, measured using a Likert scale questionnaire. Timepoint: In the post-anesthesia care unit after surgery. Method of measurement: A short patient comfort questionnaire with Likert scale responses. Systolic blood pressure measured at predefined intervals after spinal anesthesia. Timepoint: At baseline before spinal anesthesia, every 2 to 4 minutes during the first 20 minutes after the block, and every 15 minutes thereafter until 60 minutes after the block or until the end of surgery. Method of measurement: Non-invasive blood pressure monitoring using an automated oscillometric blood pressure device. Diastolic blood pressure measured at predefined intervals after spinal anesthesia. Timepoint: At baseline before spinal anesthesia, every 2 to 4 minutes during the first 20 minutes after the block, and every 15 minutes thereafter until 60 minutes after the block or until the end of surgery. Method of measurement: Non-invasive blood pressure monitoring using an automated oscillometric blood pressure device. Mean arterial pressure measured at predefined intervals after spinal anesthesia. Timepoint: At baseline before spinal anesthesia, every 2 to 4 minutes during the first 20 minutes after the block, and every 15 minutes thereafter until 60 minutes after the block or until the end of surgery. Method of measurement: Non-invasive blood pressure monitoring using an automated oscillometric blood pressure device. Heart rate measured at predefined intervals after spinal anesthesia. Timepoint: At baseline before spinal anesthesia, every 2 to 4 minutes during the first 20 minutes after the block, and every 15 minutes thereafter until 60 minutes after the block or until the end of surgery. Method of measurement: Continuous electrocardiography monitoring. Peripheral oxygen saturation measured at predefined intervals after spinal anesthesia. Timepoint: At baseline before spinal anesthesia and continuously during surgery. Method of measurement: Pulse oximetry. Research team (self-funded) Approved 2026-08-28 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Vice Chancellery for Research and Technology, 1st Floor, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd., Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)