Comparison of the effect of infusion of propofol and dexmedetomidine on hemodynamic parameters and sedation in the recovery room in patients undergoing laparoscopic Cholecystectomy

Determining the effectiveness of the infusion of two drugs, propofol and dexmedetomidine, on hemodynamic parameters and sedation in the recovery room in patients undergoing laparoscopic cholecystectomy surgery.

A parallel-group, single-blind, randomized, phase 2 clinical trial on 64 patients. Random number generation in Excel will be used for randomization

The effect of propofol and dexmedetomidine on hemodynamic parameters and sedation in the recovery room in patients who will undergo laparoscopic cholecystectomy surgery in Shahid Jalil Hospital, Yasouj city is investigated. After induction of anesthesia and for continuation of anesthesia, patients are divided into two groups. For one group, propofol with a dose of 75-120 µg/kg/min and for the other group, dexmedetomidine with a bolus dose of 0.5-1 µg/kg and then a maintenance dose of 0.1-1 µg/kg/hour is infused until the end of the operation. . Hemodynamic changes, level of sedation in patients during operation and recovery are checked and recorded in the data collection questionnaire. Also, during recovery, the level of restlessness and relief of patients is evaluated based on the RASS scale

Elective surgery, no addiction, consent to participate in the study, no comorbidities, no allergy to the study drugs, no use of benzodiazepines, no pregnancy and breastfeeding, and no conversion of laparoscopy to open surgery.

The group receiving propofol infusion and the group receiving dexmedetomidine infusion.

heart rate, systolic blood pressure, diastolic blood pressure and mean arterial pressure , restlessness level and relief of patients based on RASS scale.

he studied samples were divided into two groups through block random allocation process. Thus, first by multiplying the number of groups studied (two groups) by 2, the number of samples of each block is calculated equal to 4, then by factorial calculation the number of samples of each block (24 = 1 × 2 × 3 × 4 =! 4) The number of blocks resulting from all states of arrangement of individuals, 24 calculated blocks and blocks involving the possible arrangement of individuals were considered as A and C for the intervention group and B and D for the control group as follows: 12 11 10 9 8 7 6 5 4 3 2 1 BDCA BDAC BCDA BCAD BADC BACD ADCB ADBC ACDB ACBD ABDC ABCD 24 23 22 21 20 19 18 17 16 15 14 13 DCBA DCAB DBCA DBAC DACB DABC CDBA CDAB CBDA CBAD CADB CABD Since the number of people in each block was 4 people and the estimated sample size was 60 people, so by matching 20 random numbers generated by the Sample Randomizer software with the number of the above blocks, how to arrange 64 people research simple and assign each number from one to Sixty four to one of the specific intervention groups and a block random allocation list were compiled. In order to create sequences and concealment, online software with the following address will be used, and a special randomization code will be generated. Sealed Envelope Ltd. 2021. Create a blocked randomisation list. [Online] Available from: https://www.sealedenvelope.com/simple-randomiser/v1/lists

Blinding is done in such a way that the person who randomizes and assigns people to groups does not know the patients and will not have any information about the patients' condition. Patients will not know about the medicine received. The preparation of drugs is done by an anesthesiologist who has no role in the study. The study is conducted in a blinded manner and the patient will not know the type of drug received and the grouping from the data collector and the results analyzer.

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will be limited. 5 months after publication

researchers

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Afshin Mansourian

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