Comparing the effects of intravenous dexmedetomidine infusion 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

A triple-blind clinical trial on 165 male and female patients aged 18-60 years undergoing laparoscopic cholecystectomy with the aim of reducing pain, nausea and vomiting. Randomized sample collection with 3 parallel groups, phase 3, patients receiving placebo, dexmedetomidine and dexamethasone.

The study is a triple-blind randomized clinical trial and includes patients with a diagnosis of laparoscopic cholecystectomy who will be evaluated in 1404 at Al-Zahra Hospital in Isfahan. The participant, clinical caregiver, researcher, and data analyst in this study are blinded, and only the outcome analyst is awake.

Inclusion criteria: Patient consent to enter the study/ Patient must be a candidate for laparoscopic cholecystectomy/ American Society of Anesthesiologists (ASA) Class II-I/ No prior history of chemotherapy/ Age 18 to 60 years/ Maximum duration of operation 150 minutes Inclusion criteria: Preoperative steroid use/ Allergy to dexamethasone or dexmedetomidine/ Pregnancy

The group that received 0.5-1 µg of dexmedetomidine as a bolus over ten minutes and a dose of 0.7-0.2 µg/kg/h infusion. The group that received 4 mg/2 ml of dexamethasone in a single dose and 0.1 mg/kg of normal saline in a final volume of 20 cc. The group that received placebo (normal saline).

Nausea, pain, vomiting, systolic and diastolic blood pressure, heart rate, o2sat

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.

-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.