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IRCT20210502051160N1 IRCT 2021-07-11 Zanjan University of Medical Sciences Comparison of the effect of norepinephrine and phenylephrine infusion for the prevention of hypotension during spinal anaesthesia for caesarean section Comparison of the effect of norepinephrine and phenylephrine infusion for the prevention of hypotension during spinal anaesthesia for caesarean section 2021-06-10 anticipated 100 Complete https://irct.ir/trial/56221 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, the restricted randomization method we use the block randomization type. Blocking is used to balance the number of samples assigned to each of the study groups. This feature helps the researcher to equate the number of samples assigned to each of the study groups whenever intermediate analyzes are needed during sampling. The size of all the blocks is equal and in this two-group experiment we will have 6 blocks (including 3 people in the intervention group and 3 people in the control group).software allocation Random is used for randomization. In addition to simple randomization, these softwares are able to generate random sequence by blocking method. For concealment, we use concealment allocation, which is the method used to execute a random sequence on the study participants, so that the assigned group is not known before the individual is assigned. Using opaque envelopes with random sequences (envelopes opaque, sealed, numbered sequentially), each of the random sequences created is written on a card and the cards are placed inside the envelopes in order.In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed in a box, respectively. At the time of arrival of eligible pregnant mothers, according to the order of inclusion in the study, one of the envelopes is opened and the assigned group of the pregnant mother is revealed, Blinding description: The drug will be inserted anonymously into the infusion syringe. 3 hypotension during spinal anaesthesia. Intervention 1: Patients in intervention group 1: After spinal anesthesia for cesarean section in pregnant women, intravenous infusion of norepinephrine 5 micrograms per minute up to a maximum of 60 ml per minute is started.Intervention group:. Intervention 2: Patients in intervention group 2: After spinal anesthesia for cesarean section in pregnant women, intravenous infusion of phenylephrine half a mg per minute to a maximum of 60 ml per minute is started.Intervention group:. 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 more information
public Saeed Jalili
Ayatollah Mousavi Educational and Medical Center, Gavazang, Zanjan, IRAN.
Zanjan Iran (Islamic Republic of) 4513956183 +98 24 3313 0000 jalili@zums.ac.ir Zanjan University of Medical Sciences scientific Saeed Jalili
Ayatollah Mousavi Educational and Medical Center, Gavazang, Zanjan, IRAN.
Zanjan Iran (Islamic Republic of) 4513956183 +98 24 3313 0000 jalili@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Patients candidate for cesarean section selectively Term pregnancy (37 full weeks) and singleton Patients with anesthesia class (ASA) 1 and 2 No abuse of drugs, drugs and alcohol 18 years 35 years Female Congenital malformations of the neonate Patients in a position suspected of having a dead fetus Patients whose previous cesarean section is midline I95.81 Postprocedural hypotension Prevention Prevention Patients in intervention group 1: After spinal anesthesia for cesarean section in pregnant women, intravenous infusion of norepinephrine 5 micrograms per minute up to a maximum of 60 ml per minute is started.Intervention group: Patients in intervention group 2: After spinal anesthesia for cesarean section in pregnant women, intravenous infusion of phenylephrine half a mg per minute to a maximum of 60 ml per minute is started.Intervention group: Blood pressure. Timepoint: per one minute. Method of measurement: electronical pressure gauge. Zanjan University of Medical Sciences Approved 2021-04-27 Ethics Committee of Zanjan University of Medical Sciences Vice-Chancellor for Research and Technology, 3th Floor, 2th Bldg., Zanjan University of Medical Sciences, Azadi Blvd. Zanjan, IRAN. Zanjan Zanjan Iran (Islamic Republic of)