Investigation of the prophylactic effect of intravenous ketamine on the amount of bleeding and intravenous oxytocin consumption in elective cesarean section

The effect of intravenous ketamine on bleeding and intravenous oxytocin usage during elective cesarean section

A double-blinded and randomized clinical trial with a control group and parallel groups design of 210 patients

This study is performed as a clinical trial in Al-Zahra Hospital in Rasht. Eligible patients first receive sufficient explanations, then informed consent will be obtained. Initially, by convenience sampling, pregnant women who are candidates for elective cesarean section by regional anesthesia method will be selected. They will be divided into two groups of ketamine and control using block size of 4.ِ Drugs will be prepared by a trained anesthesia technician in exactly the same syringes and provided to the anesthesiologist. In both groups, oxytocin is prescribed after childbirth. Immediately after the umbilical cord clamp.In the intervention group, ketamine, and in the control group, normal saline will be administered. The number of oxytocin units consumed, amount of bleeding, and possible complications will be recorded in both groups. In this study, patients and evaluator are blind. The evaluation will be performed by the responsible anesthesia assistant.

Inclusion criteria:Pregnant women candidates for elective cesarean section,Regional anesthesia method Exclusion criteria:allergic to ketamine,history of seizure or psychological illnesses

Intervention group:0.25 milligrams per kilogram of intravenous ketamine(Ampule 500 milligram in 10 milliliters, manufacturer: Sterop, country: Belgium) will be administered immediately after the umbilical cord clamp. control group:2 milliliters of normal saline will be administered immediately after the umbilical cord clamp.

Bleeding rate,oxytocin consumption,complications(hallucination,nausea,vomiting)

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.

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.