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IRCT20210114050036N1 IRCT 2021-04-17 Yazd University of Medical Sciences Comparison of two different doses of intrathecal ropivacaine in patients undergoing cesarean section ASA Comparison of two different doses of intrathecal ropivacaine on onset and duration of sensory and motor block in patients undergoing cesarean section with spinal anesthesia 2018-09-23 anticipated 66 Complete https://irct.ir/trial/53719 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This clinical trial was designed by simple randomization using a random number table. The project partner placed participants with even random numbers in the intervention group (30 mg rupivacaine) and participants with odd random numbers in the control group (20 mg rupivacaine) in order of entry of participants, Blinding description: After obtaining informed consent, participants were placed in group 1 or 2 by a project partner using a random number table. The participant and the researcher did not know any of the assignments in the groups. Rupivacaine-containing syringes were prepared and coded by a design partner with an equal volume of 6 cc. Half of the syringes contained 30 mg of 0.5% ropivacaine with a volume of 6 cc and the other half contained 20 mg of 0.5% ropivacaine and 2 cc of normal saline with a volume of 6 cc. During the project, depending on the assignment of the participant to group 1 or 2, the project partner, as the only informed person, delivers the syringe containing rupivacaine (20 or 30 mg) to the researcher for intrathecal injection. Therefore, the specialist physician did not know the concentration of rupivacaine in the syringes and evaluated the patients during the study. 3 Investigation of the onset and duration of sensory and motor blocks in the administration of two different doses of intrathecal ropivacaine. Intervention 1: Intervention group: 30 mg rupivocaine 0.5% made by Molteni company with a volume of 6 cc was injected intrathecally in the L4-L5 space. Intervention 2: Intervention group: 20 mg rupivocaine 0.5% made by Molteni company with 2 cc of normal saline, in a syringe with a volume of 6 cc was injected intrathecally inL4-L5 space. Yes - There is a plan to make this available What will be shared: All data are shareable after unidentified individuals When: Access period starts 6 months after the publication of the results To whom: Data will be available to researchers working in academic and scientific institutions Conditions: Studied data can be used to compare with similar researches Where to obtain: Refer to the e-mail, dr.m.niknafs@gmail .com How to obtain: After sending the reason for the request for data files and reviewing it, the documents will be sent within two weeks Comments:
public Mojdeh Niknafs
No. 6, Etehadieh Ave, Shahid Sadooghi Blvd
Yazd Iran (Islamic Republic of) 8917697145 +98 35 3725 8222 mh.yavari@shahed.ac.ir Yazd University of Medical Sciences scientific Mojdeh Niknafs
No. 6, Etehadieh Ave, Shahid Sadooghi Blvd
Yazd Iran (Islamic Republic of) 8917697145 +98 35 3725 8222 mh.yavari@shahed.ac.ir Yazd University of Medical Sciences Iran (Islamic Republic of) Term pregnancy ASA Class 1 Candidates for non-emergency cesarean section under the spinal anesthesia 18 years 40 years Female Fetal anomalies Heart, liver, kidney or cerebrovascular diseases Preeclampsia and eclampsia Weighting less than 50 kg or more than 100 kg Sensitivity to any of the drugs used in the study For any reason that the patient needs general anesthesia Patient dissatisfaction for entering to the study Other Other Intervention group: 30 mg rupivocaine 0.5% made by Molteni company with a volume of 6 cc was injected intrathecally in the L4-L5 space Intervention group: 20 mg rupivocaine 0.5% made by Molteni company with 2 cc of normal saline, in a syringe with a volume of 6 cc was injected intrathecally inL4-L5 space Onset and duration of sensory block. Timepoint: Examine the sensory level in first minute and then every 2 minutes to 15 minutes and then every 15 minutes to an hour, then every 10 minutes until the sensory level returns to T10. Method of measurement: Pin-prick test using a 22 Gauge needle. Onset and duration of motor block. Timepoint: Investigation of the motor block in first minute and then every 2 minutes to 15 minutes and then every 15 minutes to an hour, then every 10 minutes until motor block return to a scale lower than the maximum movement block created. Method of measurement: Modified Bromage scale. Systolic, diastolic and mean arterial pressure. Timepoint: At the beginning of study (before the intervention) and then every 3 minutes until the baby was born and then every 5 minutes until the end of surgery. Method of measurement: Non-invasive blood pressure monitoring. Heart rate. Timepoint: Continuously from the beginning of the study (before the intervention) until the end of surgery. Method of measurement: Electrocardiogram monitoring. Yazd University of Medical Sciences Approved 2018-06-26 Ethics Committee of Yazd Shahid Sadoughi University of Medical Sciences No. 6, Etehadieh Ave, Shahid Sadooghi Blvd Yazd Yazd Iran (Islamic Republic of)