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IRCT20211228053560N1 IRCT 2022-12-29 Karaj University of Medical Sciences Comparison of the duration of spinal anesthesia in Trendelenburg and reverse Trendelenburg positions Comparison of the duration of spinal anesthesia in elective cesarean section in Trendelenburg and reverse Trendelenburg positions 2022-12-21 anticipated 60 Complete https://irct.ir/trial/66142 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In block randomization, in order to hide the allocation process, which is the most important principle in randomized clinical trials, the size of the blocks is considered unequal. Blocking is used in order to balance the number of samples allocated to each of the studied groups. This feature helps researchers to ensure that the number of samples allocated to each of the study groups is equal in cases where intermediate analyzes are needed during the sampling process. Blocking is done in two ways: in the first method, the size of all blocks is equal (for example, in a two-group experiment, blocks of 8 including 4 participants in the intervention group and 4 participants in the control group) and in the second method, the size of the block are randomly selected (for example: blocks of 8, 6, 10 and 14 in which there are equal numbers of each group in each block).The purpose of block randomization is to make sure that an equal number of participants enter the intervention and control groups at consecutive but equal time intervals.The samples will be randomly assigned to one of two groups. For randomization, the block randomization method with unequal block sizes (4, 6, and 8 blocks) will be used {to equalize the volume of samples in two groups and hide the allocation process}. To prepare the list, the web software at the following internet address will be used (by giving the required inputs, including the total sample size and the size of the blocks). This list is only in the hands of the researcher who has no role in the allocation and evaluation of the results.In this method, each random sequence is created and recorded on a card, and the cards are placed in the envelopes in order. In order to maintain a random sequence, the numbering on the outer surface of the envelopes is done in the same order and it is pasted in the letter envelopes and placed inside a box. At the beginning of the registration of the participants, one of the letter envelopes, the flow of the order of entry of the qualified participants into the study, will be opened and the time group of that company will be revealed. https://www.sealedenvelope.com/simple-randomiser/v1/lists. N/A Comparison of the duration of spinal anesthesia in elective caesarean section candidates in Trendelenburg and Reverse Trendelenburg positions. Intervention 1: Intervention group: The first group is placed in the 10-degree Trendelenberg position after receiving spinal anesthesia. Then patients receive 3cc of 0.5% aspen hyperbaric marcaine through Dr. Japan Co. Ltd. spinal needle No. 25 in the third and fourth lumbar space in the sitting position. The injection should be done by one person and with only one try. The duration of spinal anesthesia from the time when the movement of the leg is completely stopped and disturbed until he can fully bend his knee in minutes, in this group by the researcher It will be recorded and compared with the other group. The level of spinal anesthesia will be recorded and compared according to the dermatome before the cesarean section and every 15 minutes during recovery in both groups. To ensure the removal of anesthesia, Broomage criteria will be used. Also, during this period, the baby's blood pressure, heart rate, arterial oxygen saturation and Apgar will be recorded. Intervention 2: Intervention group: After receiving spinal anesthesia, the second group is placed in a 10-degree inverted Trendelenburg position. Then, the patients receive 3cc of 0.5% aspen hyperbaric marcaine through a Dr.Japan Co.Ltd spinal needle No. 25 in the third space and They receive a fourth lumbar in the sitting position. The injection should be done by one person and with only one try. The duration of spinal anesthesia from the time when the movement of the leg is completely stopped and disturbed until he can fully bend his knee in minutes, in this group by the researcher It will be recorded and compared with the other group. The level of spinal anesthesia will be recorded and compared according to the dermatome before the cesarean section and every 15 minutes during recovery in both groups. To ensure the removal of anesthesia, Broomage criteria will be used. Also, during this period, the baby's blood pressure, heart rate, arterial oxygen saturation and Apgar will be recorded. Yes - There is a plan to make this available What will be shared: All the data and results of the study will be available after de-identification as a thesis in the library resource of Alborz University of Medical Sciences. When: The access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: It can be used in line with humanitarian goals and the advancement of science Where to obtain: Alborz University of Medical Sciences How to obtain: After joining the electronic library of Alborz University of Medical Sciences, access is immediately free. Comments:
public susan rahimi
No. 4 , second west laleh , boostan 14 ave. , baqestan
karaj Iran (Islamic Republic of) 3194874714 +98 26 3432 3588 swsnrhymy@gmail.com Karaj University of Medical Sciences scientific Banafsheh Mashak
No. 82 , east 410 Ave. , Mehrshahr Faz4 , Karaj , Alborz
karaj Iran (Islamic Republic of) 3183816589 +98 26 3351 4522 mashakbanafsheh@yahoo.com Karaj University of Medical Sciences Iran (Islamic Republic of) The study will be conducted on people aged 20-45 Height range 155-170 cm and ASAII Termination of pregnancy should be during the term (37-42 weeks). The patient should undergo spinal anesthesia. The pregnant mother has not used any special drugs. The pregnant mother does not have any underlying disease. The mother does not have any drug addiction BMI is less than 30 20 years 45 years Female Treatment - Other Treatment - Other Intervention group: The first group is placed in the 10-degree Trendelenberg position after receiving spinal anesthesia. Then patients receive 3cc of 0.5% aspen hyperbaric marcaine through Dr. Japan Co. Ltd. spinal needle No. 25 in the third and fourth lumbar space in the sitting position. The injection should be done by one person and with only one try. The duration of spinal anesthesia from the time when the movement of the leg is completely stopped and disturbed until he can fully bend his knee in minutes, in this group by the researcher It will be recorded and compared with the other group. The level of spinal anesthesia will be recorded and compared according to the dermatome before the cesarean section and every 15 minutes during recovery in both groups. To ensure the removal of anesthesia, Broomage criteria will be used. Also, during this period, the baby's blood pressure, heart rate, arterial oxygen saturation and Apgar will be recorded. Intervention group: After receiving spinal anesthesia, the second group is placed in a 10-degree inverted Trendelenburg position. Then, the patients receive 3cc of 0.5% aspen hyperbaric marcaine through a Dr.Japan Co.Ltd spinal needle No. 25 in the third space and They receive a fourth lumbar in the sitting position. The injection should be done by one person and with only one try. The duration of spinal anesthesia from the time when the movement of the leg is completely stopped and disturbed until he can fully bend his knee in minutes, in this group by the researcher It will be recorded and compared with the other group. The level of spinal anesthesia will be recorded and compared according to the dermatome before the cesarean section and every 15 minutes during recovery in both groups. To ensure the removal of anesthesia, Broomage criteria will be used. Also, during this period, the baby's blood pressure, heart rate, arterial oxygen saturation and Apgar will be recorded. Duration of spinal anesthesia. Timepoint: After receiving spinal anesthesia, the first group is placed in the 10-degree Trendelenberg position and the second group is placed in the 10-degree reverse Trendelenberg position. The duration of spinal anesthesia from the time when the movement of the leg is completely stopped and disturbed every 15 minutes, until the time when he can fully bend his knee in minutes, will be recorded and compared by the researcher in two groups. The level of spinal anesthesia based on the dermatome will be recorded in both groups before the cesarean section and every 15 minutes during recovery until the patient can fully bend the knee. Method of measurement: The duration of spinal anesthesia from the time when the leg movement is completely stopped and impaired until he can fully bend his knee in minutes will be recorded and compared by the researcher in two groups. Karaj University of Medical Sciences Approved 2022-09-13 Ethics committee of Alborz University of Medical Sciences No. 4 , Pardis builing , second west Laleh , Boostan 14 Ave. , Baqestan , Karaj karaj Alborz Iran (Islamic Republic of)