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IRCT20160307026950N8 IRCT 2018-07-27 Esfahan University of Medical Sciences Effects of low dosage of midazolam plus ketamine and low dose ketamine plus midazolam on shivering Comparison of the effect of low dosage of midazolam plus ketamine and low dose ketamine plus midazolam on postoperative shivering after spinal anesthesia. 2017-06-22 anticipated 120 Complete https://irct.ir/trial/22209 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients are randomly assigned to the 3 groups of A, B, and C using random number table, Blinding description: All drugs are prepared and placed at the same volume and homogeneously into the syringes by the investigator. The hemodynamic changes (after the administration of each drug) are monitored and recorded. Moreover, the Participants, Care provider, Outcome assessor, and Data analyser are not aware of the drug type and the investigator deciphers the codes after data analysis. 3 shivrring. Intervention 1: Intervention group B: Initially, personal consent is obtained from the patients. Then the patient is placed on the operating bed and standard monitoring devices including pulsoximetry, capnography, and electrocardiogram are attached. In this group, low dose Midazolam and Ketamine are injected and subsequent shivering is checked. Intervention 2: Intervention group C: Initially, personal consent is obtained from the patients. Then the patient is placed on the operating bed and standard monitoring devices including pulsoximetry, capnography, and electrocardiogram are attached. In this group, low dose midazolam and ketamine are injected and induced shivering in them will be checked. In this group, low dose Ketamine and midazolam are injected and subsequent shivering in them is checked. Intervention 3: Control group A: Initially, personal consent is obtained from the patients. Then the patient is placed on the operating bed and standard monitoring devices including pulsoximetry, capnography, and electrocardiogram are attached. In this group, low dose Midazolam and Ketamine are injected subsequent shivering in them is checked. In this group, Normal saline is injected and resultant shivering in them is checked. In this group, Normal saline is injected and subsequent shivering in them is checked. Yes - There is a plan to make this available What will be shared: Only registered symptoms can be published without mentioning the names of the participants When: Starting the access period 6 months after printing results To whom: Only available to scholars working in academia and academia Conditions: Written request via email and university approval Where to obtain: By contacting the corresponding author How to obtain: After the email is received by the applicant, it takes one week to agree The university will be obtained and then will be notified to the requestor. Maximum of this process takes ten days. Comments:
public Sara Azizollahi
Baghdaryache
Isfahan Iran (Islamic Republic of) 7516769337 +98 37764766 sazizollahi24@gmail.com Esfahan University of Medical Sciences scientific Behzad Nazemroaya
Ostandari
Isfahan Iran (Islamic Republic of) 8146713543 +98 32247233 b.nazemroaya@khuisf.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) age 18 to 45 years old Candidate for surgery Anesthesia Technique Spinal Anesthesia ASAI,ASAII 18 years 45 years Both Change in Anesthesia Technique Bleeding during blood transfiusion Allergy to the drug Prevention Prevention Placebo Intervention group B: Initially, personal consent is obtained from the patients. Then the patient is placed on the operating bed and standard monitoring devices including pulsoximetry, capnography, and electrocardiogram are attached. In this group, low dose Midazolam and Ketamine are injected and subsequent shivering is checked. Intervention group C: Initially, personal consent is obtained from the patients. Then the patient is placed on the operating bed and standard monitoring devices including pulsoximetry, capnography, and electrocardiogram are attached. In this group, low dose midazolam and ketamine are injected and induced shivering in them will be checked. In this group, low dose Ketamine and midazolam are injected and subsequent shivering in them is checked. Control group A: Initially, personal consent is obtained from the patients. Then the patient is placed on the operating bed and standard monitoring devices including pulsoximetry, capnography, and electrocardiogram are attached. In this group, low dose Midazolam and Ketamine are injected subsequent shivering in them is checked. In this group, Normal saline is injected and resultant shivering in them is checked. In this group, Normal saline is injected and subsequent shivering in them is checked. Shivering. Timepoint: Recovery Duration. Method of measurement: In minutes using the timer. Temperature of Peripheral. Timepoint: At the base time; after the procedure and then every 15 minutes until discharge of recovery. Method of measurement: Skin Thermometer. Central temperature. Timepoint: At the base time; after the procedure and then every 15 minutes until discharge of recovery. Method of measurement: Tympanic thermometer. Heart Rate. Timepoint: At the base time; after the procedure and then every 15 minutes until discharge of recovery. Method of measurement: Electrocardiogram. Mean Arterial Blood Pressure. Timepoint: At the base time; after the procedure and then every 15 minutes until discharge of recovery. Method of measurement: Non invasive blood pressure measurement. Oxygen saturation. Timepoint: At the base time; after the procedure and then every 15 minutes until discharge of recovery. Method of measurement: Pulse oximetry device. Duration of surgery. Timepoint: The time to start the surgery until the end of the surgery. Method of measurement: Minute. Duration of stay in recovery. Timepoint: From admission to recovery until discharge. Method of measurement: Minute. Nausea and Vomiting. Timepoint: During stay in recovery. Method of measurement: Questionnaire. Esfahan University of Medical Sciences Approved 2017-05-24 Ethics committee of Isfahan University of Medical Sciences Hezar jarib Isfahan Isfehan Iran (Islamic Republic of)