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IRCT20120110008677N7 IRCT 2021-10-29 Mehr Medical Institute The effect of anesthesia agents on intracytoplasmic injection of sperm outcome Comparison of the effect of two drug combinations remifentanil propofol and ketamine propofol on hemodynamic parameters and reproductive outcome after intracytoplasmic sperm injection in patients undergoing oocyte retrieval with general anesthesia a double blind randomized clinical trial 2021-11-21 anticipated 200 Complete https://irct.ir/trial/58872 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization will be done using computer software. The list of blocks will be written and numbers will be assigned to them (AABB (1) - ABAB (2) -ABBA (3) -BBAA (4) - BABA (5) - BAAB (6)), then random numbers between one and six ( For example, 1 4 5, etc.) will be select and finally the treatment allocation list based on previous random numbers (AABB, BBAA, BABA, etc.) will be specified, Blinding description: At the anesthesia visit, all the conditions of the study will be explained by a respected anesthesiologist. If the patient wishes to participate in the study, written consent will be obtained. The patient knows exactly two drugs and generally knows the methods and drugs, but does not know exactly which drug he has received. The analyzer is also unaware of the nature of the two groups. The specialist doctor is aware of two groups. 3 Infertility. Intervention 1: Intervention group: Induction of anesthesia in group ketamine propofol, ketofol drug containing: propofol 1-1.5 mg/kg with 0.5 mg/kg ketamine. Lidocaine 40 mg is prescribed to reduce the pain of propofol injection. Anesthesia will be continued with incremental doses of 30 to 50 mg propofol as needed. Intervention 2: Control group: Induction of anesthesia in group remifentanil propofol will be performed with remifentanil 1 to 1.5 μg/kg and propofol 2 mg/kg. Lidocaine 40 mg is prescribed to reduce the pain of propofol injection. Anesthesia will be continued with incremental doses of 30 to 50 mg propofol as needed. 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 No decision has been made yet
public Farnoush Farzi
Mehr Medical Institute, Ershad St, Ansari Blv, Rasht, Iran
Rasht Iran (Islamic Republic of) 4178613111 +98 13 3376 4270 farnoush_farzi@yahoo.com Mehr medical institute scientific Farnoush Farzi
Mehr Medical Institute, Ershad St, Ansari Blv, Rasht, Iran
Rasht Iran (Islamic Republic of) 4178613111 +98 13 3376 4270 farnoush_farzi@yahoo.com Mehr Medical Institute Iran (Islamic Republic of) American Society of Anesthesiologists Classification grade I and II Age less than 42 years 18 years 41 years Female Preimplantation genetic screening cycles Signs of poor ovarian response History of cardiorespiratory disease Chronic drug use Allergy to anesthetics N97 Female infertility Treatment - Drugs Treatment - Drugs Intervention group: Induction of anesthesia in group ketamine propofol, ketofol drug containing: propofol 1-1.5 mg/kg with 0.5 mg/kg ketamine. Lidocaine 40 mg is prescribed to reduce the pain of propofol injection. Anesthesia will be continued with incremental doses of 30 to 50 mg propofol as needed. Control group: Induction of anesthesia in group remifentanil propofol will be performed with remifentanil 1 to 1.5 μg/kg and propofol 2 mg/kg. Lidocaine 40 mg is prescribed to reduce the pain of propofol injection. Anesthesia will be continued with incremental doses of 30 to 50 mg propofol as needed. Fertilization rate. Timepoint: One day after intracytoplasmic injection of sperm. Method of measurement: Stereo microscope. Clinical pregnancy. Timepoint: Six to seven weeks after embryo transfer. Method of measurement: Ultrasonography. Response time to voice commands. Timepoint: Following discontinuation of anesthesia agents. Method of measurement: Questionnaire. Mehr Medical Institute Approved 2021-09-15 Ethics Committees of Guilan university of medical sciences Shahid Siadati Ave, Namjoo St, Rasht, Iran Rasht Guilan Iran (Islamic Republic of)