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IRCT20230728058951N1 IRCT 2023-10-22 Shahid Beheshti University of Medical Sciences Studying effect of Dexmedetomidine on postoprative Nausea & Vomiting(PONV) Studying effect of Dexmedetomidine on postoprative Nausea & Vomiting(PONV)In Laparascopic Cholecystectomy in Addict patient 2023-11-22 anticipated 100 Complete https://irct.ir/trial/71946 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The sampling is random, and the allocation is done according to the table of random numbers in two groups and the ratio of one to one in the intervention and control groups is done according to the sample size formula. Receiving dexmedetomidine or placebo are assigned based on the random number generation table. Patients are divided into two groups of 50 and each patient is randomly assigned a number. The control group includes numbers 1 to 50 and the intervention group includes numbers 51 to 100, Blinding description: 100 patients with drug addiction (according to the definition), candidates for laparoscopic cholecystectomy in Shohada Tajrish Hospital, who meet the entry criteria for the study, are informed by the trained personnel about the implementation and objectives of the study, and if they wish to participate in the study A written consent form is obtained from them and then each patient is classified according to the classification made using the random block division method and placed in the group receiving dexmethomidine (intervention group) or the placebo group (control group) means 2 groups of 50 people. It should be noted that if a patient is removed from the study for any reason, a person who has no knowledge of the intervention group and the control group will be randomly replaced with a new patient who meets the criteria for entering the project. With this process, the number of evaluated patients may exceed 100. Before the operation, each patient is interviewed by an anesthesiologist and demographic, hemodynamic, history and entry criteria are collected and the information is recorded in the relevant form. Dexmethomidine and placebo drugs are prepared with the same shape, color, size and packaging and are coded as A&B before injection by a person other than the researcher. The group under intervention with dexmethomidine drug 10 minutes after induction under dexmethomidine infusion 1 mcg/kg /min is placed and this continues until the end of the operation. And the placebo group also receives normal saline infusion 10 minutes after induction until the end of the procedure. The information is recorded from the time of arrival until 120 minutes later by the medical evaluator who does not know the type of patient group. After collecting all the information of the patients, this information will compiled into two files (the intervention group with dexmedetomidine and the control group with placebo) and will be used statistically. 3 Effect of dexmedetomidine on postoperative nausea and vomiting (PONV). Intervention 1: intervention group: The intervention group (including 50 people) will be subjected to intravenous infusion of dexmethomidine (an alpha 2 agonist drug) with dose of 1 mcg/kg/min, just from 10 minutes after induction of anesthesia until the end of the operation. Intervention 2: Control group: The placebo group was given intravenous infusion of normal saline (0.9% saline), which is a physiological liquid,just from 10 minutes after induction of anesthesia until the end of the procedure. Yes - There is a plan to make this available What will be shared: All the necessary information according to the regulations of the desired journal to print the article is available in the file sent to the journal office. When: Until the publication of the article To whom: all of people Conditions: For public use, especially in the country's health sector Where to obtain: Magazine office How to obtain: The desired and prescribed procedures of the journal office for publication and printing of articles Comments: The useful point cannot be mentioned
public Mohamad Hosein Rezaei
Unit21- No3 - Peyvandi St - Dastgerdi St - Shariati Ave
Tehran Iran (Islamic Republic of) 1911853173 +98 21 2640 9546 sepidsaman35@gmail.com Shahid Beheshti University of Medical Sciences scientific Houman Teymurian
Shohadaye Tajrish Educational Medical Center,Shahadari St.,Tajrish Square
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2271 8002 houman72625@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with a history of addiction (according to definition) Age between 20 and 60 years ASA class one and two Blood pressure 24 hours before and during the operation between 140 and 90 mmHg 20 years 60 years Both Intraoperative laparotomy Surgery lasting more than 4 hours Heavy bleeding ASA class three Any history of heart disease History of gastrointestinal disease Presence of nausea and vomiting before surgery Drug withdrawal symptoms before surgery Taking antiemetics History of motion sickness or PONV R11 Nausea and vomiting Prevention Placebo intervention group: The intervention group (including 50 people) will be subjected to intravenous infusion of dexmethomidine (an alpha 2 agonist drug) with dose of 1 mcg/kg/min, just from 10 minutes after induction of anesthesia until the end of the operation. Control group: The placebo group was given intravenous infusion of normal saline (0.9% saline), which is a physiological liquid,just from 10 minutes after induction of anesthesia until the end of the procedure. Post operative Nausea and vomiting (ponv) is one of the most unpleasant experiences that has important consequences on patient satisfaction, treatment results and related costs, and is one of the common causes of morbidity after surgery. Grades of (ponv) include nausea, retching, regurgitation or vomiting.  ponv:It is one of the common causes of morbidity after surgery, which usually occurs during the recovery phase and ends spontaneously within 24 hours.it includes nausea that can end in retching or vomiting or regurgitation.  Nausea:This is an unpleasant feeling that refers to the urge to vomit and is not accompanied by muscle movement outside the driver.  Vomiting:It is the strong excretion of even small amounts of the contents of the upper GI tract through the mouth.  Regurgitation:It is the exit of material from the pharynx or esophagus with low pressure, which is usually characterized by the presence of undigested food or blood.  Retching:When even with muscular ejector efforts, no contents of the stomach are expelled through the mouth. Timepoint: Measurement of presence Post operative nausea & vomitting and its levels in 15, 30, 45, 60, 90 and 120 minutes after the operation. Method of measurement: The interview includes asking the patient or the patient's complaint (in cases of nausea and regurgitation) and observation (in cases of vomiting and retching). The secondary outcome variables are the degrees of postoperative nausea and vomiting including: nausea, regurgitation, retching, and vomiting, which were explained earlier. Timepoint: Measuring the degree of postoperative nausea and vomiting in 15, 30, 45, 60, 90 and 120 minutes after the surgery. Method of measurement: The interview includes asking the patient or the patient's complaint (in cases of nausea and regurgitation) and observation (in cases of vomiting and retching). Shahid Beheshti University of Medical Sciences Approved 2023-05-29 Ethics committee of Shahid Beheshti University of Medical Sciences 13th floor, Block A, Central Headquarters of the Ministry of Health, Treatment and Medical Education, Simai Iran Street, between South Flamak St. and Zarafshan, Quds Town (West Town ), Tehran Tehran Tehran Iran (Islamic Republic of)