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IRCT20160307026950N35 IRCT 2021-09-06 Esfahan University of Medical Sciences The effect of Dexmedetomidine on nausea and vomiting in Discectomy surgery Comparison of the effectiveness of two different doses of Dexmedetomidine on the prevention of nausea and vomiting in Discectomy under spinal anesthesia 2019-06-22 anticipated 135 Complete https://irct.ir/trial/57151 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: This is a simple randomized clinical trial in which individuals enter study groups by lottery; The drugs and placebo are placed in the desired number in sealed opaque and uniform sealed envelopes. Each of the codes is also written on a piece of paper, folded and placed inside a box. After entering the operating room, each patient takes one of the papers out of the box. Which is applied to the patient. This continues until the end of the paperwork so that the number of patients in the desired volume in the groups, Blinding description: This was a double-blind controlled clinical trial in which the patient and the evaluator had no known information about the type and dose of the drug. 3 Nausea and vomiting due to Discectomy under spinal anesthesia. Intervention 1: Intervention group D1: From the time of entering the operating room until before spinal anesthesia, 500cc of Ringer's lactate serum made in Iran was administered intravenously to patients. After entering the operating room, before spinal anesthesia and dexmedetomidine injection, blood pressure (by non-invasive sphygmomanometer), arterial oxygen saturation (SpO2) were measured by pulse oximetry and baseline vital signs. Then 0.2 micrograms per kilogram of body weight per hour Dexmedetomidine made in Germany, which was increased to 10cc by normal saline, after spinal anesthesia and placing the patient in the desired position, was received as an intravenous infusion pump for 10 minutes. After that, the patient's vital signs were measured and recorded again until the end of surgery and then in recovery. Intervention 2: Intervention group D2: From the time of entering the operating room until before spinal anesthesia, 500cc of Ringer's lactate serum made in Iran was administered intravenously to patients. After entering the operating room, before spinal anesthesia and dexmedetomidine injection, blood pressure (by non-invasive sphygmomanometer), arterial oxygen saturation (SpO2) were measured by pulse oximetry and baseline vital signs. Then 0.5 micrograms per kilogram of body weight per hour Dexmedetomidine made in Germany, which was increased to 10cc by normal saline, after spinal anesthesia and placing the patient in the desired position, was received as an intravenous infusion pump for 10 minutes. After that, the patient's vital signs were measured and recorded again until the end of surgery and then in recovery. Intervention 3: Control group C: From the time of entering the operating room until before spinal anesthesia, 500cc of Ringer's lactate serum made in Iran was administered intravenously to patients. After entering the operating room, before spinal anesthesia, blood pressure (by non-invasive sphygmomanometer), arterial oxygen saturation (SpO2) were measured by pulse oximetry and baseline vital signs. Then, 10cc of normal saline made by Saha Med Company, after spinal anesthesia and placing the patient in the desired position, was received as an intravenous infusion pump for 10 minutes. After that, the patient's vital signs were measured and recorded again until the end of surgery and then in recovery. 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 There is no more information
public Negar Khan ahmad
Hezar Jarib
Isfahan Iran (Islamic Republic of) 8146713543 +98 31 3620 2020 behzad_nazem@med.mui.ac.ir Esfahan University of Medical Sciences scientific Behzad Nazem roaya
Hezar Jarib
Isfahan Iran (Islamic Republic of) 8146713543 +98 31 3620 2020 behzad_nazem@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients 18 to 60 years Candidate for Discectomy under spinal anesthesia Grade 1 and 2 Anesthesia Based on American Society Anesthesia Criteria 18 years 60 years Both History of cardiovascular, respiratory, neurological, endocrine, thyroid, neuromuscular diseases, dysautonomia Fever Obesity (BMI> 27) History of vasoactive drugs, MAOI and TCA History of drug use Allergy to Pethidine, Ketamine and Magnesium sulfate Pregnancy Allergy to Dexmedetomidine Taking drugs with drug interactions with Dexmedetomidine Prevention Prevention Placebo Intervention group D1: From the time of entering the operating room until before spinal anesthesia, 500cc of Ringer's lactate serum made in Iran was administered intravenously to patients. After entering the operating room, before spinal anesthesia and dexmedetomidine injection, blood pressure (by non-invasive sphygmomanometer), arterial oxygen saturation (SpO2) were measured by pulse oximetry and baseline vital signs. Then 0.2 micrograms per kilogram of body weight per hour Dexmedetomidine made in Germany, which was increased to 10cc by normal saline, after spinal anesthesia and placing the patient in the desired position, was received as an intravenous infusion pump for 10 minutes. After that, the patient's vital signs were measured and recorded again until the end of surgery and then in recovery. Intervention group D2: From the time of entering the operating room until before spinal anesthesia, 500cc of Ringer's lactate serum made in Iran was administered intravenously to patients. After entering the operating room, before spinal anesthesia and dexmedetomidine injection, blood pressure (by non-invasive sphygmomanometer), arterial oxygen saturation (SpO2) were measured by pulse oximetry and baseline vital signs. Then 0.5 micrograms per kilogram of body weight per hour Dexmedetomidine made in Germany, which was increased to 10cc by normal saline, after spinal anesthesia and placing the patient in the desired position, was received as an intravenous infusion pump for 10 minutes. After that, the patient's vital signs were measured and recorded again until the end of surgery and then in recovery. Control group C: From the time of entering the operating room until before spinal anesthesia, 500cc of Ringer's lactate serum made in Iran was administered intravenously to patients. After entering the operating room, before spinal anesthesia, blood pressure (by non-invasive sphygmomanometer), arterial oxygen saturation (SpO2) were measured by pulse oximetry and baseline vital signs. Then, 10cc of normal saline made by Saha Med Company, after spinal anesthesia and placing the patient in the desired position, was received as an intravenous infusion pump for 10 minutes. After that, the patient's vital signs were measured and recorded again until the end of surgery and then in recovery. Nausea and vomiting due to dexmedetomidine injection. Timepoint: Immediately after spinal up to 24 hours after surgery. Method of measurement: Use Visual Analogue Scale or VAS. Heart Rate. Timepoint: Immediately after spinal up to 24 hours after surgery. Method of measurement: ECG monitoring. Systolic blood pressure. Timepoint: Immediately after spinal up to 24 hours after surgery. Method of measurement: Barometer. Diastolic blood pressure. Timepoint: Immediately after spinal up to 24 hours after surgery. Method of measurement: Barometer. Arterial blood oxygen saturation. Timepoint: Immediately after spinal up to 24 hours after surgery. Method of measurement: Pulse oximeter. Esfahan University of Medical Sciences Approved 2021-07-24 Ethics Committee in Biomedical Research, Isfahan University of Medical Sciences Hezar Jarib St Isfahan Isfehan Iran (Islamic Republic of)