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IRCT20211112053042N3 IRCT 2022-09-17 Karaj University of Medical Sciences The effect of raising the head after spinal anesthesia on blood pressure and level of anesthesia in elective cesarean delivery The effect of Head elevation after spinal anesthesia on hemodynamic and sensory block height during elective cesarean delivery in pregnant women referred to Maryam Hospital 2022-10-01 anticipated 60 Complete https://irct.ir/trial/65894 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Study subjects will be divided into two groups, control and intervention, using a simple randomization method and using a table of random numbers. First, each person is assigned a number. Then, using the table of random numbers, each selected number is randomly assigned to one of the groups, and this work continues until the number of people in each group is completed. Therefore, the researcher will not have the authority to change the status of the assignment of people or to predict it. Randomization concealment will be done by a third person who does not participate in other stages of the intervention. 2-3 Spinal anesthesia. Intervention 1: Intervention group: Spinal anesthesia is performed in the sitting position from the L2-L3 or L3-L4 spaces with the Midline approach using a Quincke needle 25 gage and 8-12 ml of 0.1% ropivacaine. The patient's head is elevated 30 degrees with a simple pillow. Intervention 2: Control group: Spinal anesthesia is performed like the intervention group without elevating the patient's head. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals. When: Access period starts 6 months after the results are published. To whom: Research centers and faculty members Conditions: At the request of the researcher and faculty members Where to obtain: Send email to the scientific respondent How to obtain: Within two months from the time of requesting and sending the email, the documents will be sent to the mentioned people Comments:
public Mohammad Hossein Delshad MD.
Arghavan Gharbi, 45 meters from Golshahr Street, Karaj, Alborz Province
Karaj Iran (Islamic Republic of) 3198683639 +98 26 3350 2347 m.delshad@abzums.ac.ir Karaj University of Medical Sciences scientific Mohammad Hossein Delshad MD.
Arghavan Gharbi, 45 meters from Golshahr Street, Karaj, Alborz Province
Karaj Iran (Islamic Republic of) 3198683639 +98 26 3350 2347 m.delshad@abzums.ac.ir Karaj University of Medical Sciences Iran (Islamic Republic of) Pregnant women with consent to participate in the project Pregnant women with ASA Class I, II Gestation age 39-37 weeks Singleton 18 years 50 years Female Pregnant women with lack of consent to participate in the project Diseases related to pregnancy such as gestational hypertension, preeclampsia, gestational diabetes Multiple births Known fetal anomaly Local infection History of drug abuse People who are unable to maintain the position when the needle is inserted History of spine surgery Presence of wound and infection at the needle entry site O89. 4 Spinal and epidural anesthesia Prevention Prevention Intervention group: Spinal anesthesia is performed in the sitting position from the L2-L3 or L3-L4 spaces with the Midline approach using a Quincke needle 25 gage and 8-12 ml of 0.1% ropivacaine. The patient's head is elevated 30 degrees with a simple pillow. Control group: Spinal anesthesia is performed like the intervention group without elevating the patient's head. The height of the sensory block. Timepoint: Every 5 minutes from the time of spinal injection until the embryo is removed and the end of the surgery. Method of measurement: By pinprick test. Systolic blood pressure. Timepoint: Every minute from the time of spinal injection until the fetus is removed and then every 5 minutes. Method of measurement: Measurement with pressure gauge. Diastolic blood pressure. Timepoint: Every minute from the time of spinal injection until the fetus is removed and then every 5 minutes. Method of measurement: Measurement with pressure gauge. Heart rate. Timepoint: Every minute from the time of spinal injection until the fetus is removed and then every 5 minutes. Method of measurement: Measurement with non-invasive devices. Oxygen saturation. Timepoint: Every minute from the time of spinal injection until the fetus is removed and then every 5 minutes. Method of measurement: Pulse Oximetry. Maternal complications. Timepoint: Every minute from the time of spinal injection until the fetus is removed. Method of measurement: Doctor's diagnosis. Apgar score. Timepoint: At 1 and 5 minutes after birth. Method of measurement: Neonatal specialist examination. Karaj University of Medical Sciences Approved 2022-06-24 Ethics committee of Alborz University of Medical Sciences second floor, Deputy of Research and Technology, Saffarian Alley, 45 meters from Golshahr, Karaj. Karaj Alborz Iran (Islamic Republic of)