Authors
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[No authors listed]
Category
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Primary study
Registry of Trials»Iranian Registry of Clinical Trials
Year
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2022
INTERVENTION: 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 CONDITION: K80‐K87 Laparascopic cholecystectomy. ; ?????? ??? ???? ?????????? ?????? ? ??????? PRIMARY OUTCOME: 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. 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). 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. INCLUSION CRITERIA: 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 SECONDARY OUTCOME: 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. Intense feeling of thirst. Timepoint: Upon entering the operating room. Method of measurement: Question from 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. 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 the feeling of hunger. Timepoint: Upon entering the operating room. Method of measurement: Question from the patient. Shivering score based on Crossley criteria. Timepoint: In the recovery section and 2 hours after the operation. Method of measurement: Crossley criteria.
Epistemonikos ID: 7bfe1f6d0e4a62687c73509d407b0a62c611b044
First added on: Jun 25, 2022