The effect of oral consumption of honey water (ma-ol-asal) on postoperative complications and the quality of recovery in laparoscopic cholecystectomy

Determining the effect of oral honey consumption on postoperative complications and quality of recovery in patients undergoing laparoscopic cholecystectomy

Clinical trial with control group, parallel groups, double-blind, randomized on 68 patients, we will use random sequencing software to randomize

The study population includes all patients who are candidates for laparoscopic cholecystectomy and are eligible to study who have referred to hospitals in the west of Mazandaran province in 1400-1401. The study is double-blind. The prescribing physician, assistant and patient will not know any of the contents of the drugs and the drug code will be written on the file.

Inclusion criteria: Laparoscopic cholecystectomy Age between 18 and 65 years To be fasting Having a BMI (body mass index) between 18 and 30 Exclusion criteria: Having nausea and indigestion Drug addiction Being pregnant while studying Having a history of allergies to honey compounds Changes in surgical procedures

Intervention group: Honey syrup will be produced by NIAK Pharmaceutical Company with the permission of the Food and Drug Administration of the Ministry of Health and Medical Education. This syrup contains compounds of honey, cinnamon, ginger, saffron, cardamom, kholnjan, mastaki, jozboa and basbaseh. Control group: Placebo syrup is also prepared in Niak Pharmaceutical Company, which is packaged in bottles completely similar to honey. The placebo will contain water, acesulfame, sunset yellow and carboxymethylcellulose. Honey will be administered twice in the intervention group and placebo in the control group twice a day, twice before the operation (eight and two hours before the operation) with An anesthesiologist (15 ml) will be consulted

nausea and vomiting, pain, bloating ،quality of recovery.

In this study, we will use the Restricted Randomization method of the Blocked Randomization type. Blocking is usually used to balance the number of samples assigned to each of the study groups. This feature helps researchers to ensure that the number of samples assigned to each of the study groups is equal in cases where intermediate analyzes are required during the sampling process. Randomization tool: We will use random sequence software (Random allocation software). In addition to simple randomization, these softwares are able to generate random sequences by blocking method. To hide the Allocation Concealment, we will use opaque sealed, sealed, opaque envelopes. This method is used to perform a random sequence on the study participants. In such a way that the assigned group is not known before the individual is assigned. The random assignment sequence and the list of blocks will be obtained by the statistics consultant with the help of random software. Use 4 blocks to create a random allocation. According to the total number of samples required for the study, which is 68 patients, 34 patients in intervention group (A), 34 patients in control group (B), 17 quadruple blocks including groups A and B are randomly designed through the software. For example, (ABAB), (BABA), (AABB), (BBAA), (BAAB) .... Based on the list of randomly prepared quadruple blocks, a trained person outside the research team is responsible for allocating patients randomly. Obtaining informed written consent, according to the 17 quadruple blocks prepared in the first stage, will be randomly assigned to the intervention group (A) and the control group (B). For example, according to the block (ABAB), each patient enters the intervention, control, intervention and control groups, respectively, after entering the study. This process continues until the last block is selected.

Blinding will be two-way blind, so that the drug and placebo in the company are made by people who are not involved in the study and will be packaged and coded in the same way. The person doing the coding will have no role in the study until the end of the intervention. The prescribing physician, assistant, and patient will not be aware of any of the contents of the medications, and the medication code will be written on the file (double blind).