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IRCT20211018052806N1 IRCT 2022-06-24 Mazandaran University of Medical Sciences The effect of oral consumption of honey water (ma-ol-asal) on postoperative complications and the quality of recovery in laparoscopic cholecystectomy The effect of oral consumption of honey water (ma-ol-asal) on postoperative complications and the quality of recovery in laparoscopic cholecystectomy 2022-04-04 anticipated 68 Complete https://irct.ir/trial/62704 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: 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 description: 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). 3 Laparascopic cholecystectomy. Intervention 1: Intervention group: Honey syrup will be produced by NIAK Pharmaceutical Company with the license of the Food and Drug Administration of the Ministry of Health and Medical Education with registration number License number: S-94-0425. This syrup contains ingredients of honey, cinnamon, ginger, saffron, cardamom, kholnjan, mastaki, jozboa and basbaseh, and the instructions for making the medicine according to the manufacturer's instructions are: 1- Honey with 2 times its amount, water poured into the container and mixed. Becomes. 2- The resulting mixture is placed at a temperature of 55 to 60 degrees Celsius and under a vacuum of 50 to 70 mm Hg to find the appropriate concentration and its volume reaches two thirds of the total initial volume. 3- From the very beginning of the heat, ginger, cinnamon, saffron, cardamom, kholnjan, mastaki, josboa and basbaseh medicines are poured into a cotton bag and hung in a container containing a mixture of water and honey for 24 hours. 4- Then the bag is taken out and the resulting material is filtered. 5. The resulting solution is packed in 200 cc bottles. 6- In every 100 cc of compound honey syrup, there are 2 grams of cinnamon, 2 grams of cardamom, 1 gram of ginger, 1 gram of kholnjan, 1 gram of saffron and 1 gram of mastic, 1 gram of gooseberry and 1 gram of basal. 7- Finally, tests of appearance characteristics, pH, density, viscosity, dry weight of the extract, microbial and fungal control are performed by NIAK Pharmaceutical Company on the final product. Assessment of quality and quality control of honey is done by NIAK company according to USP40 pharmacopoeia standard. Honey administration in the intervention group and placebo in the control group will be twice a day, so that 2 times before the operation (eight and two hours before the operation in consultation with an anesthesiologist) (15 ml), the allowable dose of the prescribed drug For an adult human, 60 kg is 30 cc. Intervention 2: Control group: Placebo syrup is also prepared in NIAK Pharmaceutical Company, which is packaged in bottles completely similar to honey. Placebo will contain water, acesulfame with a volume weight of 0.05 and sunset yellow with a percentage of 0.003 and carboxymethylcellulose with a content of 0.7 percent. Acesulfame is a synthetic sweetener without calories, is not metabolized in the body and is excreted intact. Artificial dye is edible. Carboxymethylcellulose acts as a thickener, preservative of shape and appearance (rheology). These compounds are used in the permitted and standard amounts in placebo. Will be given 2 times before the operation (eight or two hours before the operation in consultation with the anesthesiologist) (15 ml). 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 There is no more information.
public Sahar Ghorban Shamsi
at the end of Shahid Haghparast Stree, Sadatshahr
Ramsar Iran (Islamic Republic of) 4693173975 +98 11 5521 3507 shamsiiisahar@gmail.com Mazandaran University of Medical Sciences scientific Ebrahim Nasiri Formi
School of Paramedical Sciences, Payambar Azam University Complex,17 km of Farahabad road.
Sari Iran (Islamic Republic of) 4847116548 +98 911 151 7836 rezanf2002@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Laparoscopic gallbladder surgery,,, age between 18 and 65 years , NPO BMI between 18 and 30, PS patients one and two (either have no underlying disease or have controlled underlying disease) tend to Participate in the study and give informed consent 18 years 65 years Both Having vestibular symptoms (nausea caused by ear diseases) Known gastrointestinal diseases (such as colitis, gastritis, etc.) Drug and benzodiazepine addiction Having nausea Unawareness and having psychotic symptoms Have a history of allergies to honey compounds (especially cinnamon or other plants with similar families) Being pregnant while studying Consumption of antiemetics and vomiting other than the treatment protocol The patient's inability to continue cooperating for any reason, such as loss of consciousness, death of the patient Inability of the patient to determine the severity of nausea and bloating despite the instructions Complete lack of access to the patient Changes in surgical procedures and intraoperative anesthesia for any reason K80-K87 بیماری های کیسه صفرا،مجاری صفراوی و پانکراس Treatment - Other Placebo Intervention group: Honey syrup will be produced by NIAK Pharmaceutical Company with the license of the Food and Drug Administration of the Ministry of Health and Medical Education with registration number License number: S-94-0425. This syrup contains ingredients of honey, cinnamon, ginger, saffron, cardamom, kholnjan, mastaki, jozboa and basbaseh, and the instructions for making the medicine according to the manufacturer's instructions are: 1- Honey with 2 times its amount, water poured into the container and mixed. Becomes. 2- The resulting mixture is placed at a temperature of 55 to 60 degrees Celsius and under a vacuum of 50 to 70 mm Hg to find the appropriate concentration and its volume reaches two thirds of the total initial volume. 3- From the very beginning of the heat, ginger, cinnamon, saffron, cardamom, kholnjan, mastaki, josboa and basbaseh medicines are poured into a cotton bag and hung in a container containing a mixture of water and honey for 24 hours. 4- Then the bag is taken out and the resulting material is filtered. 5. The resulting solution is packed in 200 cc bottles. 6- In every 100 cc of compound honey syrup, there are 2 grams of cinnamon, 2 grams of cardamom, 1 gram of ginger, 1 gram of kholnjan, 1 gram of saffron and 1 gram of mastic, 1 gram of gooseberry and 1 gram of basal. 7- Finally, tests of appearance characteristics, pH, density, viscosity, dry weight of the extract, microbial and fungal control are performed by NIAK Pharmaceutical Company on the final product. Assessment of quality and quality control of honey is done by NIAK company according to USP40 pharmacopoeia standard. Honey administration in the intervention group and placebo in the control group will be twice a day, so that 2 times before the operation (eight and two hours before the operation in consultation with an anesthesiologist) (15 ml), the allowable dose of the prescribed drug For an adult human, 60 kg is 30 cc. Control group: Placebo syrup is also prepared in NIAK Pharmaceutical Company, which is packaged in bottles completely similar to honey. Placebo will contain water, acesulfame with a volume weight of 0.05 and sunset yellow with a percentage of 0.003 and carboxymethylcellulose with a content of 0.7 percent. Acesulfame is a synthetic sweetener without calories, is not metabolized in the body and is excreted intact. Artificial dye is edible. Carboxymethylcellulose acts as a thickener, preservative of shape and appearance (rheology). These compounds are used in the permitted and standard amounts in placebo. Will be given 2 times before the operation (eight or two hours before the operation in consultation with the anesthesiologist) (15 ml). Nausea score based on visual analog scale. Timepoint: Upon entering the operating room, during recovery, 2 and 24 hours after surgery. Method of measurement: Visual analog scale. Number of vomiting times based on patient observation. Timepoint: Upon entering the operating room, during recovery, 2 and 24 hours after surgery. Method of measurement: Patient observation. Variable bloating score based on visual analog scale. Timepoint: Upon entering the operating room, during recovery, 2 and 24 hours after surgery. Method of measurement: visual analog scale. Pain variable score based on visual analog scale. Timepoint: Upon entering the operating room, during recovery, 2 and 24 hours after surgery. Method of measurement: visual analog scale. Recovery quality score based on QOR-40 questionnaire (40-200). Timepoint: 2, 12 and 24 hours after surgery. Method of measurement: Recovery Quality Questionnaire (QOR-40). Intensity of the feeling of hunger. Timepoint: Upon entering the operating room. Method of measurement: Question from the patient. Intense feeling of thirst. Timepoint: Upon entering the operating room. Method of measurement: Question from the patient. Blood pressure level. Timepoint: Upon entering the operating room before induction of anesthesia, after co2 gas injection, in the recovery section, at the time of discharge from recovery and 2 hours after surgery. Method of measurement: Blood pressure manometer and vital signs monitor. Heart rate. Timepoint: Upon entering the operating room before induction of anesthesia, after co2 gas injection, in the recovery section, at the time of discharge from recovery and 2 hours after surgery. Method of measurement: Vital Signal Monitor and Pulse Oximeter. Shivering score based on Crossley criteria. Timepoint: In the recovery section and 2 hours after the operation. Method of measurement: Crossley criteria. Intensity of shoulder pain. Timepoint: When discharge from recovery, 2 and 24 hours after surgery. Method of measurement: Observe and ask the patient. Intensity of Headache, dry mouth, feeling cold, feeling weak, feeling tired before the operation. Timepoint: Upon entering the operating room. Method of measurement: Observe and ask the patient. Mazandaran University of Medical Sciences Approved 2022-05-14 Ethics Committee of Mazandaran University of Medical Sciences Mazandaran University of Medical Sciences, beginning of Vali-e-Asr Highway, Joybar Three Ways, Imam Square Sari Mazandaran Iran (Islamic Republic of)