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IRCT20170314033069N3 IRCT 2020-12-31 Vice President of Research Guilan university of medical sciences The effect of ketamine on bleeding and oxytocin consumption during cesarean section Investigation of the prophylactic effect of intravenous ketamine on the amount of bleeding and intravenous oxytocin consumption in elective cesarean section 2020-12-21 anticipated 210 Complete https://irct.ir/trial/52609 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of initial selection of individuals to enter the project will be in the form of convenience sampling of pregnant women who are candidates for elective cesarean section by regional anesthesia method. Eligible patients will be divided into two groups of ketamine and normal saline (control) using block size of 4, created by the computer and WinPepi Ver.11.65 software which is prepared by the methodology consultant, Blinding description: In this study, the patient and the evaluator are unaware of the treatment groups. The evaluation will be performed by an anesthesia assistant. drugs include ketamine and normal saline will be prepared by a trained anesthesia technician who is not in the study, in exactly the same syringes, and from a list of eligible patients, one by one from each group using a random list. After that it will be given to the anesthesia assistant.ِDrugs will be injected to the patients of both groups, Immediately after the umbilical cord clamp. The number of oxytocin units, primary outcomes (bleeding rate based on changes in hemoglobin levels) before and after surgery as well as secondary outcomes (complications such as nausea, vomiting, hallucinations) during surgery and in recovery will be recorded by the anesthesia assistant. 3 Maternal care to reduce bleeding during cesarean section. Intervention 1: Intervention group: Eligible patients first receive adequate explanations of this research and then informed consent is obtained. After the baby's birth, oxytocin will be given at a rate of 0.4 units per minute. Then immediately after the umbilical cord clamp, 0.25 milligrams per kilogram of intravenous ketamine (Ampule 500 milligram in 10 milliliters, manufacturer: Sterop, country: Belgium) will be prescribed. Intervention 2: Control group: Eligible patients first receive adequate explanations of this research and then informed consent is obtained. After the baby's birth, oxytocin will be given at a rate of 0.4 units per minute. Then immediately after the umbilical cord clamp, 2 milliliters of intravenous normal saline will be prescribed. 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 Not decided yet
public Dr Gelareh Biazar
Anesthesiology Research Center, Alzahra Hospital, Namjoo Street, Rasht, Iran
Rasht Iran (Islamic Republic of) 4144654839 +98 13 3332 9524 gelarehbiazar1386@gmail.com Anesthesiology Research Center scientific Dr Gelareh Biazar
Anesthesiology Research Center, Alzahra Hospital, Namjoo Street, Rasht, Iran
Rasht Iran (Islamic Republic of) 4144654839 +98 13 3332 9524 gelarehbiazar1386@gmail.com Anesthesiology Research Center Iran (Islamic Republic of) Pregnant women candidates for elective cesarean section Regional anesthesia method no limit no limit Female Reluctant to participate in the project allergic to ketamine history of seizures history of psychological illnesses O26 Maternal care for other conditions predominantly related to pregnancy Treatment - Drugs Placebo Intervention group: Eligible patients first receive adequate explanations of this research and then informed consent is obtained. After the baby's birth, oxytocin will be given at a rate of 0.4 units per minute. Then immediately after the umbilical cord clamp, 0.25 milligrams per kilogram of intravenous ketamine (Ampule 500 milligram in 10 milliliters, manufacturer: Sterop, country: Belgium) will be prescribed. Control group: Eligible patients first receive adequate explanations of this research and then informed consent is obtained. After the baby's birth, oxytocin will be given at a rate of 0.4 units per minute. Then immediately after the umbilical cord clamp, 2 milliliters of intravenous normal saline will be prescribed. Bleeding rate. Timepoint: Before and after surgery. Method of measurement: Based on changes in hemoglobin levels. Oxytocin consumption. Timepoint: At the end of surgery. Method of measurement: Units per minute. Complications(nausea, vomiting and hallucination). Timepoint: During operation and in recovery. Method of measurement: observation. Vice President of Research Guilan university of medical sciences Approved 2020-11-25 Ethics committee of Guilan University of Medical Sciences Vice Chancellor for research, Shahid Siadati Avenue, Namjoo Street,Rasht Rasht Guilan Iran (Islamic Republic of)