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IRCT20180930041181N1 IRCT 2018-10-22 Ardabil University of Medical Sciences Effect of Ketamine & Propofol in prevention of Shivering The Effectiveness of low dose Ketamine and Propofol in prevention of Shivering in Patients during Sesarean section under Spinal Anesthesia 2018-11-22 anticipated 132 Complete https://irct.ir/trial/34282 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: A Convenient Sampling method will be used to enter the patients.These patients will be randomly assigned into three groups: Ketamine, Propofol and Placebo.The randomization tool will be Opaque envelopes in this study.For randomization three type of envelopes to the number of sample size is provided, an envelope randomly selected from the envelopes and based on the type of envelope code selected (type A, B and C )the prescribed drug for each code will be injected to patients.Preparing of these three drugs is done by an anesthetic technician who is not involved in this study and for injection is given to someone who is unaware of contents of the syringes.In the Ketamine group, 10 mg of ketamine and in the Propofol group, 10 mg of Propofol and 2 ml of Normal Saline will be injected in the Placebo group.For blindness the volume of injectable solution will be 2 cc in each of three groups, Blinding description: Preparing of these three drugs is done by an anesthetic technician who is not involved in this study and for injection is given to someone who is unaware of contents of the syringes.In the Ketamine group, 10 mg of ketamine and in the Propofol group, 10 mg of Propofol and 2 ml of Normal Saline will be injected in the Placebo group.For blindness the volume of injectable solution will be 2 cc in each of three groups.A person who in not aware of the type of injectable drug evaluate patients during and after surgery. The data analyst in this study will also be unaware of the type of drug used. 3 Postoperative Shivering. Intervention 1: Intervention group: 10 mg Ketamine immediately after embryo out. Intervention 2: Intervention group: 10 mg Propofol immediately after embryo out. Intervention 3: Control group: 2 cc Normal Saline. 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 more information
public Khatereh Isazadehfar
Daneshgah Ave., Ardebil University of Medical siences
Ardebil Iran (Islamic Republic of) ۸۵۹۹۱۵۶۱۸۹ +98 45 3352 2247 kh.isazadehfar@arums.ac.ir Ardabil University of Medical Sciences scientific Dr Ahmad Ghazi
Daneshgah Ave., Ardebil University of Medical siences
Ardebil Iran (Islamic Republic of) ۸۵۹۹۱۵۶۱۸۹ +98 44 3352 2247 a.ghazi@arums.ac.ir Ardabil University of Medical Sciences Iran (Islamic Republic of) Pregnant Women aged 15_45 years old Patients signed informed consent Patients with ASA class I & II 15 years 45 years Female History of previous allergy to Ketamine & Propofol Placenta Previa Preeclampsia and eclampsia Raynaud's Syndrom Thyroid disease Cardiovascular disease Psychological Problems Body temperature < 36 or > 38 Parturients with ASA class III or high T88.5 Other complications of anesthesia Treatment - Drugs Treatment - Drugs Placebo Intervention group: 10 mg Ketamine immediately after embryo out Intervention group: 10 mg Propofol immediately after embryo out Control group: 2 cc Normal Saline Shivering. Timepoint: During and after surgery. Method of measurement: Shivering score (0_4). Nausea and vomiting. Timepoint: During and after surgery. Method of measurement: Nausea and vomiting Score (1_4). Ardabil University of Medical Sciences Approved 2018-01-14 Ethics committee of Ardebil University of Medical Sciences Ardebil University of Medical Sciences Ardebil Ardabil Iran (Islamic Republic of)