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IRCT20201006048947N1 IRCT 2020-10-21 Jahrom University of Medical Sciences The effect of ondansetron on the prevention of hypotension after spinal anesthesia Effect of intravenous ondansetron in comparison with placebo on prevention of hypotension after spinal anesthesia in patients undergoing lower limb orthopedic surgery 2020-10-22 anticipated 100 Complete https://irct.ir/trial/51450 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: This clinical trial is performed in a simple randomization with individual randomization unit and in order to obtain equal sample sizes in the two groups, it is performed in a restricted randomization and by the method of random allocation rule, so that first the total sample size is determined (for example, 100 samples) and then we divide the set into group A and the set into group B, then 50 balls for intervention A and 50 balls for intervention B are placed in the lottery, then the balls are randomly drawn out without replacement. It is taken out of the container and the created sequence is recorded.To hide random allocation, opaque sealed envelopes with random sequences are used. After determining the random sequence, a number of envelopes are prepared and random sequences are recorded on the card and placed in the envelope. Envelopes are numbered sequentially, and when collecting samples, the envelopes are opened one by one and the assigned group is identified, Blinding description: Before performing spinal anesthesia, an anesthesiologist inserts syringes, half of which contain ondansetron and the other half containing placebo, and the syringes are numbered, so neither the participant nor the clinical caregiver and the researcher knows which syringe is placebo and which one is the medicine. 3 Hypotention induced by spinal anesthesia. Intervention 1: Intervention group: Patients are among the candidates for orthopedic surgery for spinal anesthesia who have no contraindications to spinal anesthesia and have been fasting for at least 8 hours receiving 300 mg of normal saline or ringer and 4 mg of ondansetron intravenously before spinal anesthesia during 30 secends. Intervention 2: Control group: Intervention group: Patients are among the candidates for orthopedic surgery for spinal anesthesia who have no contraindications to spinal anesthesia and have been fasting for at least 8 hours receiving 300 mg of normal saline or ringer and 4 mg of plasbo intravenously before spinal anesthesia during 30 secends. Yes - There is a plan to make this available What will be shared: All data will be shareable When: Access starts 6 months after the results are published To whom: Only for researchers working in academic institutions Conditions: Only for researchers working in academic institutions Where to obtain: To the researcher named Nasim Nabizadeh by calling 00989364731778 Or the postal address of Jahrom, Helal Ahmar Street, 26th Alley with postal code 7413718849 Or email nassimnabizadeh@gmail.com How to obtain: This data is available 6 months after the publication of the results and the applicant will have access to it up to one week after the announcement of the request. Comments:
public Nasim Nabizadeh
No. 26, Helal Ahmar avenue
Jahrom Iran (Islamic Republic of) 7413718849 +98 54 0022 3275 Nassimnabizadeh@gmail.com Jahrom University of Medical Sciences scientific Nasim Nabizadeh
No. 26, Helal Ahmar avenue
Jahrom Iran (Islamic Republic of) 7413718849 +98 54 0022 3275 Nassimnabizadeh@gmail.com Jahrom University of Medical Sciences Iran (Islamic Republic of) Candidates for orthopedic surgery by spinal anesthesia at Peymanieh Hospital in Jahrom Satisfaction of the person to participate in the study age between 18 to 65 years 18 years 65 years Both Patients with hypertension weight more than 100 kg motion sickness cardiac and liver desease and migrain allery to ondansetron drugs using any drugs that change blood pressure or hear rate and any drugs that effects by serotonin receptor Other Placebo Intervention group: Patients are among the candidates for orthopedic surgery for spinal anesthesia who have no contraindications to spinal anesthesia and have been fasting for at least 8 hours receiving 300 mg of normal saline or ringer and 4 mg of ondansetron intravenously before spinal anesthesia during 30 secends. Control group: Intervention group: Patients are among the candidates for orthopedic surgery for spinal anesthesia who have no contraindications to spinal anesthesia and have been fasting for at least 8 hours receiving 300 mg of normal saline or ringer and 4 mg of plasbo intravenously before spinal anesthesia during 30 secends. Percentage of people with hypotension. Timepoint: Blood pressure measurement during the first 10 minutes, every 3 minutes and then every 5 minutes until the end of 30 minutes of spinal anesthesia. Method of measurement: Measurement with heart monitoring device. Percentage of people with decreased heart rate. Timepoint: during the first 10 minutes, every 3 minutes and then every 5 minutes until the end of 30 minutes of spinal anesthesia. Method of measurement: Measuring heart rate with a heart rate monitor. Percentage of people with pruritus after spinal anesthesia. Timepoint: Every 10 minutes after spinal anesthesia. Method of measurement: by asking the patient. Percentage of people with nausea after spinal anesthesia. Timepoint: Every 10 minutes after spinal anesthesia. Method of measurement: by asking the patient. Jahrom University of Medical Sciences Approved 2020-01-22 Ethics committee of Jahrom University of Medical Sciences Jahrom University Of Medical science; Motahari street Jahrom Fars Iran (Islamic Republic of)