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IRCT20160307026950N81 IRCT 2026-06-19 Esfahan University of Medical Sciences The effect of intravenous dexmedetomidine with intravenous dexamethasone in providing analgesia and reducing nausea and vomiting after laparoscopic cholecystectomy. Comparing the effects of intravenous dexmedetomidine infusion with intravenous dexamethasone in providing analgesia and reducing nausea and vomiting after laparoscopic cholecystectomy 2026-06-22 anticipated 165 Recruiting https://irct.ir/trial/88893 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Three drugs are named A, B, and C, and only the third person who gives the drug to the patient knows which drug has which letter, and decoding is done at the end of the study. People are written from top to bottom based on the national code, and based on a random method, if the number 1 is determined, the first group, that is, three people, enters the ABC group, and the first person A, the second person B, and the third person C. If the random number 2 comes, the second group in the same way, and if the random number 3 comes, the third group, if the random number 4 comes, group 4, if the random number 5 comes, group 5, and if the random number 6 comes, group 6. If the random numbers 7, 8, and 9 come, it is repeated until one of the random numbers comes up. We have 55 random blocks of three. For example, if two patients are candidates for surgery today, we assume a third patient and form a block and specify the block. If the third patient comes in the future, his block is already specified and he will receive the desired drug, Blinding description: -The participants are the same patients who have undergone abdominal cholecystectomy surgery and are blinded in this study because the study was explained to them before consent was obtained, but they are not aware of the coding of the groups and the grouping. -The nursing and operating room staff are also blinded as clinical care because they are not aware of the grouping. -The researcher is also blinded in this study because he does not personally perform the grouping and drug injection. -The professor, statistical consultant and student (researcher) are also blinded as data analysts in this study because they only analyze and interpret the collected information. -The only group that is awake is the nursing staff and the drug injectors who collect the data and are aware of the coding of the groups and the grouping and the intervention that is performed for each patient. 3 laparoscopic cholecystectomy. Intervention 1: Intervention group:The group that received 0.5-1 µg dexmedetomidine as a bolus over ten minutes and a dose of 0.2-0.7 µg/kg/h infusion. Intervention 2: Intervention group: Group receiving 4mg/2ml dexamethasone single dose and 0.1mg/kg normal saline to a final volume of 20cc. Intervention 3: Control group: The group receiving placebo (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 availabe.
public Abolfazl Dehghani Farfani
No. 4, Shahid Mirzaei Alley, Arisoon St
Isfahan Iran (Islamic Republic of) 8159135515 0098315232492 Abolfazl.Dehghani9820@gmail.com Esfahan University of Medical Sciences scientific Behzad Nazemroaya
Hezar Jarib
Isfahan Iran (Islamic Republic of) 8174673461 0098 31 822 2532 Behzad_nazem@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patient consent to enter the study The patient is a candidate for laparoscopic cholecystectomy. American Society of Anesthesiologists (ASA) Class II-I No prior history of chemotherapy Age 18 to 60 years Maximum operation time 150 minutes 18 years 60 years Both Taking steroids before surgery Allergy to dexamethasone or dexmedetomidine being pregnant K80 Cholelithiasis Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group:The group that received 0.5-1 µg dexmedetomidine as a bolus over ten minutes and a dose of 0.2-0.7 µg/kg/h infusion Intervention group: Group receiving 4mg/2ml dexamethasone single dose and 0.1mg/kg normal saline to a final volume of 20cc Control group: The group receiving placebo (normal saline). Nausea. Timepoint: From patient recovery until 4 hours after surgery, every 30 minutes in 3 groups. Method of measurement: Ask the patient. Vomiting. Timepoint: From patient recovery until 4 hours after surgery, every 30 minutes in 3 groups. Method of measurement: Ask the patient. Pain. Timepoint: From patient recovery until 4 hours after surgery, every 30 minutes in 3 groups. Method of measurement: VAS score system. Systolic blood pressure. Timepoint: During the procedure after receiving the medication, every 15 minutes until the end of the surgery. Method of measurement: Non invasive blood pressure measurement. Diastolic blood pressure. Timepoint: During the procedure after receiving the medication, every 15 minutes until the end of the surgery. Method of measurement: Non invasive blood pressure measurement. Heart rate. Timepoint: During the procedure after receiving the medication, every 15 minutes until the end of the surgery. Method of measurement: ECG Monitoring. Blood oxygen saturation. Timepoint: During the procedure after receiving the medication, every 15 minutes until the end of the surgery. Method of measurement: Pulse oximeter. Esfahan University of Medical Sciences Approved 2026-01-20 Research Ethics Committee of Alzahra Research Centers , Isfahan University of Medical Sciences Hezar jerib Isfahan Isfehan Iran (Islamic Republic of)