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IRCT20211013052753N1 IRCT 2021-11-14 Mashhad University of Medical Sciences The effect of adding intravenous ketamine to Midazolam in reducing the need for analgesia after spinal anesthesia in elective cesarean section Investigating the effect of adding intravenous ketamine to Midazolam in reducing the need for analgesia after spinal anesthesia in elective cesarean section 2021-11-16 anticipated 40 Complete https://irct.ir/trial/59384 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization with the table of random numbers available at ''www.randomization.com'' website will be used. Numbers will be placed in sealed envelopes and these envelopes will place the participants in one of the two groups of control and intervention. An anesthetic technician injects the syringes based on the numbers obtained from the random number table and the envelopes during the cesarean section, Blinding description: In this study, participants are not aware of the type of treatment and the intervention conducted in each group. That is, the patients are not aware of the type of injection used in each group. Similarly, outcome assessors are unaware of the grouping and the type of injection prescribed for patients in each group. No placebo drug will be used in this study. 3 Fetal cesarean section. Intervention 1: Intervention group: In this group, patients are injected with 0.5 mg/kg ketamine and 0.02 mg/kg midazolam in a 2ml syringe during cesarean section after umbilical cord clamping. Intervention 2: Control group: In this group, patients are injected only with 0.02 mg/kg midazolam in a 2ml syringe during cesarean section after umbilical cord clamping. Yes - There is a plan to make this available What will be shared: All data can be shared after patients are made unidentifiable. When: Data can be accessible 6 months after results are published. To whom: Data can be accessible through an email to the corresponding author. Conditions: Data will be available for researchers in universities and other scientific institutes. Where to obtain: After sending a request email to the corresponding author, data will be sent in 1 month. How to obtain: Carrying out analysis on data is permitted. Comments:
public Saleheh Asghari
Imam Reza Hospital, next to Imam Reza square, Ibne Sina street
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3802 2406 AsghariSA@mums.ac.ir Mashhad University of Medical Sciences scientific Saleheh Asghari
Imam Reza Hospital, next to Imam Reza square, Ibne Sina street
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3802 2051 AsghariSA@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Women over the age of 18 who have elective cesarean section with ASA I (American Anesthesiology Association) no limit no limit Female History of trauma to head, addiction and use of psychiatric medication Hallucinations, delusions and hypertension Intracranial hemorrhage History of ketamine allergy O82.9 Delivery by caesarean section, unspecified Treatment - Drugs Treatment - Drugs Intervention group: In this group, patients are injected with 0.5 mg/kg ketamine and 0.02 mg/kg midazolam in a 2ml syringe during cesarean section after umbilical cord clamping. Control group: In this group, patients are injected only with 0.02 mg/kg midazolam in a 2ml syringe during cesarean section after umbilical cord clamping. Pain intensity. Timepoint: At 1,6,12 and 24 hours after labor. Method of measurement: The visual analog scale (VAS) for pain. The amount of pain medication used. Timepoint: During the first day after the intervention. Method of measurement: Based on milligrams of Apotel and meperidine used. Apgar score of the newborn. Timepoint: Minutes 1 and 4 after birth. Method of measurement: Examination. Mashhad University of Medical Sciences Approved 2021-05-25 Ethics Committee of Mashhad University of Medical Sciences Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street Mashhad Razavi Khorasan Iran (Islamic Republic of)