]>
IRCT20230516058204N1 IRCT 2023-08-05 Shahre-kord University of Medical Sciences The effect of ephedrine and hydroxyethyl starch in the prevention of hypotension Prophylactic administration of ephedrine and hydroxyethyl starch before spinal anesthesia to prevent hypotension in patients undergoing cesarean section 2023-07-11 anticipated 120 Complete https://irct.ir/trial/70853 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to randomly assign patients in the groups under investigation, the permutation block method will be used. The sample size in each block will be equal to 8, and the randomization list will be prepared by the Random Allocation software and will be given to a person who does not know the intervention content of the groups, Blinding description: Since the study is a double-blind study, the participants and the statistical consultant will not know which of the study groups the participants are in. 2-3 Low blood pressure. Intervention 1: The first intervention group: immediately after spinal anesthesia, they will receive 10 mg intravenous bolus of ephedrine. Intervention 2: The second intervention group: just before spinal anesthesia, they will receive 500 ml of hydroxyethyl starch. Intervention 3: The third intervention group: before spinal anesthesia, they will receive 500 ml of hydroxyethyl starch and immediately after spinal anesthesia, they will receive 10 mg of ephedrine intravenous bolus. Intervention 4: Control group: They will receive 500 ml of Ringer lactate infusion just before spinal anesthesia. Yes - There is a plan to make this available What will be shared: Main outcome information When: The access period starts 6 months after the results are published To whom: Only for researchers working in academic and scientific institutes Conditions: to be used in future studies Where to obtain: Zahra Heidari dr_zahra_heidari@yahoo.com How to obtain: Presenting documents of working in academic and scientific institutions Comments:
public Zahra Heidari
No. 16, 1 alley, Kashani Blvd.
Shahrekord Iran (Islamic Republic of) 8815713564 +98 38 3339 8456 dr_zahra_heidari@skums.ac.ir Shahre-kord University of Medical Sciences scientific Zahra Heidari
No. 16, 1 alley, Kashani Blvd.
Shahrekord Iran (Islamic Republic of) 8815713564 +98 38 3339 8456 dr_zahra_heidari@skums.ac.ir Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Having an ASA Class I, II term pregnancy (American Society of Anesthesiologists) Participants in the study should refer electively for caesarean section Consent to participate in the study Absence of any underlying disease Absence of contraindications for spinal anesthesia 15 years 50 years Female Presence of one of the diseases associated with pregnancy, such as gestational hypertension, gestational diabetes, fetal problems, and bleeding in the third trimester of pregnancy. Allergy to ephedrine and hydroxyethyl starch or similar drugs BMI higher than 30 Gestational age less than 37 weeks Known hypertension Known heart or lung disease Known liver or kidney disease Addiction to amphetamine, cocaine and LSD O82.9 Delivery by caesarean section, unspecified Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo The first intervention group: immediately after spinal anesthesia, they will receive 10 mg intravenous bolus of ephedrine. The second intervention group: just before spinal anesthesia, they will receive 500 ml of hydroxyethyl starch. The third intervention group: before spinal anesthesia, they will receive 500 ml of hydroxyethyl starch and immediately after spinal anesthesia, they will receive 10 mg of ephedrine intravenous bolus. Control group: They will receive 500 ml of Ringer lactate infusion just before spinal anesthesia. Blood pressure drop. Timepoint: During the operation. Method of measurement: By using the monitoring device. Shahre-kord University of Medical Sciences Approved 2023-02-08 Ethics committee of Shahrekord University of Medical Sciences No. 16, 1 alley, Kashani Blvd. Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)