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IRCT20230417057937N1 IRCT 2023-08-12 Shahre-kord University of Medical Sciences Investigating the effect of ketamine in pain control after cesarean section The effect of Different Doses and side effects of Ketamin for Pain Control after Cesarean Section Surgery in Patients with Spinal Anesthesia 2023-08-23 anticipated 120 Complete https://irct.ir/trial/70001 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation of participants to 3 groups will be done by permutation blocks with a size of 40. The Random Allocation software will prepare the randomization list and will be given to a person who does not know the content of the groups' interventions, Blinding description: In order to make the study double-blind, the patients will be selected by a person who has no role in examining the patient based on the list of random numbers and the file number will be selected as codes 1, 2, and 3, and the drug and placebo will be injected by the researcher, and the patient will be examined before and It is also performed by the researcher after cesarean section. The patient does not know what group he is in, and the statistical consultant will only know about the studied groups in the form of codes. 2-3 Post-surgery pain. Intervention 1: The first intervention group: Ketamine is initially given as a bolus dose of 0.25 mg/kg and then as a continuous infusion of 0.125 mg/kg during the operation. Intervention 2: The second intervention group: Ketamine is initially given as a bolus dose of 0.5 mg/kg and then as a continuous infusion of 0.25 mg/kg during the operation. Intervention 3: Control group: they will receive normal saline injection equal to the volume of liquid injected in the intervention groups. 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: amin rabiei aminrabiei1997@gmail.com How to obtain: Presenting documents of working in academic and scientific institutions Comments:
public Amin Rabiei
Kashani dormitory, Kashani Blvd.
Shahrekord Iran (Islamic Republic of) 8813733424 +98 38 3452 3824 aminrabiei1997@gmail.com Shahre-kord University of Medical Sciences scientific Amin Rabiei
Kashani dormitory, Kashani Blvd.
Shahrekord Iran (Islamic Republic of) 8813733424 +98 38 3452 3824 aminrabiei1997@gmail.com Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Having a term pregnancy and ASA(American Society of Anesthesiologists) class I, II Participants in the study should refer electively for caesarean section Consent to participate in the study Absence of any underlying diseases Absence of any mental illnesses or mental disorders 18 years 35 years Female The presence of one of the diseases associated with pregnancy, such as gestational blood pressure or gestational diabetes and fetal problems. Allergy to ketamine or similar drugs BMI above 30 O74.8 Other complications of anaesthesia during labour and delivery Treatment - Drugs Treatment - Drugs Placebo The first intervention group: Ketamine is initially given as a bolus dose of 0.25 mg/kg and then as a continuous infusion of 0.125 mg/kg during the operation. The second intervention group: Ketamine is initially given as a bolus dose of 0.5 mg/kg and then as a continuous infusion of 0.25 mg/kg during the operation. Control group: they will receive normal saline injection equal to the volume of liquid injected in the intervention groups. Comparison of postoperative pain scores in patients receiving intravenous ketamine and the group receiving normal saline. Timepoint: 0, 30, 60, 90, 120 minutes and 4, 6, 12, 24 hours after cesarean سثزفهخد. Method of measurement: Analogue Scale Visual. Determining the relative frequency of hallucinations in the group receiving intravenous ketamine. Timepoint: 20 minutes after receiving the first dose of medicine. Method of measurement: Based on questions from the patient. The time required for pain medication after the completion of spinal anesthesia. Timepoint: The first 24 hours after cesarean section. Method of measurement: Time of drug administration. Apgar score of the newborn. Timepoint: The first and fifth minutes after birth. Method of measurement: It includes 5 components: heart rate, respiratory effort, muscle tone, reflex excitability, color. Shahre-kord University of Medical Sciences Approved 2022-06-08 Ethics committee of Shahrekord University of Medical Sciences Kashani Blvd Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)