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IRCT20230316057741N1 IRCT 2023-04-09 Yasouj University of Medical Sciences The effect of ketamine along with gabapentin on complications of spinal anesthesia in caesarean section Evaluation of the effect of ketamine with gabapentin on the severity of some complications of spinal anesthesia in cesarean section 2023-05-20 anticipated 120 Complete https://irct.ir/trial/69305 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, eligible patients are randomly divided into four groups. Randomization will be simple and individual. The names of each patient will be written as a number on a piece of paper and will be placed inside the appropriate envelopes, four people will randomly remove them from the envelopes and each will enter one of the four groups, Blinding description: Care provider will not informed about the type of intervention received by patients. 3 Complications after cesarean section. Intervention 1: Intervention first group: Receive gabapentin (single oral dose, 300 mg) 30 minutes before surgery. Intervention 2: Intervention second group: Ketamine (intravenous dose of 0.25mg/kg as a single bolus dose) five minutes after cord clamping. Intervention 3: Intervention third group: ُSimultaneous administration of ketamine (intravenous dose of 0.25 mg/kg as a single bolus dose) along with gabapentin (single oral dose, 300 mg). Intervention 4: Control group: Receiving placebo (intravenous distilled water). Yes - There is a plan to make this available What will be shared: The intended data that is the result of this study and can be published includes the results of the study and the data of participants without names and identity information after the study is conducted and if necessary after the publication of the article from this study with the person responsible and responsible for the project. It can be shared if you contact them. When: The access period starts 3 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: The data obtained from this study is only allowed for further study and further analysis is also allowed for review studies and meta-analysis and otherwise it will not be available for other matters. Where to obtain: zasadik66@gmail.com How to obtain: Eligible people to receive documents must send a written and signed letter from the scientific institute or the scientific board of one of the universities to the given email address. Comments:
public Zahra Asadi Kalemeh
International Affairs Office, Central Library, Yasuj University of Medical Sciences, Shahid Dr. Jalil St., Yasuj, Kohgilouyeh and Boyer-Ahmad Province, Iran.
Yasuj Iran (Islamic Republic of) 7591741417 +98 74 3323 3257 zasadik66@gmail.com Yasouj University of Medical Sciences scientific Zahra Asadi Kalemeh
International Affairs Office, Central Library, Yasuj University of Medical Sciences, Shahid Dr. Jalil St., Yasuj, Kohgilouyeh and Boyer-Ahmad Province, Iran.
Yasuj Iran (Islamic Republic of) 7591741417 +98 74 3323 3257 zasadik66@gmail.com Yasouj University of Medical Sciences Iran (Islamic Republic of) No emergency C/S surgery No emergency C/S surgery No emergency C/S surgery Type of surgical incision on the skin of Von Stilweber on the uterus, transverse incision on the lower uterine segment (kerr) Absence of underlying disease such as weak immune system, diabetes, high blood pressure, cardiopulmonary disease, blood disease, autoimmune disease, severe liver hepatitis, asthma, pancreatitis, or coagulation disorders. Singleton pregnancy Not taking special medicine Gestational age greater than or equal to 28 weeks Being in the low risk group based on the risk factors of PPH, including placenta previa, placental abruption, hypertension, HELLP syndrome, macrosomia, non-cephalic presentation, intrauterine infection or the use of assisted reproductive technology (ART). Mother's BMI based on pre-pregnancy weight less than 30 kg/m2 Natural plt counting 18 years 34 years Female Any contraindications for spinal anesthesia Any contraindications to receiving ketamine or gabapentin Severe bleeding during C/S If any of the patients in the placebo group suffer from any of the side effects that cannot be tolerated by the patient, the patient will be treated for the side effects with the opinion of the relevant specialist, and the patient will be excluded from the study. Z38.01 Single liveborn infant, delivered by cesarean Prevention Prevention Prevention Prevention Intervention first group: Receive gabapentin (single oral dose, 300 mg) 30 minutes before surgery. Intervention second group: Ketamine (intravenous dose of 0.25mg/kg as a single bolus dose) five minutes after cord clamping. Intervention third group: ُSimultaneous administration of ketamine (intravenous dose of 0.25 mg/kg as a single bolus dose) along with gabapentin (single oral dose, 300 mg) Control group: Receiving placebo (intravenous distilled water) Severity of postoperative nausea and vomiting. Timepoint: Their nausea and vomiting at intervals of 1, 2, 3, 4 and 6 hours. Method of measurement: A Visual Analogue Scale will be used to measure the severity of nausea and vomiting after the operation. Severity of postoperative headache. Timepoint: Headache at intervals of 1, 6, 12 hours after the operation. Method of measurement: A Visual Analogue Scale will be used to measure the severity of headache. Postoperative patient satisfaction score. Timepoint: Post-operation. Method of measurement: A Visual Analogue Scale will be used to measure the patient satisfaction. Yasouj University of Medical Sciences Approved 2023-02-15 Ethics Committee of Yasouj University of Medical Sciences Yasouj University of Medical Sciences, MHHQ+493, Shahid Motahari Blvd, Kohgiluyeh and Boyer-Ahmad Province, Yasuj Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)