This was a triple-blind clinical trial. The inclusion criteria included the lack of cancer, an age of 18 - 60 years, lack of pregnancy, ability to take the capsules, platelets count of > 100000, free from conditions such as GI obstruction, seizure, hepatitis, diabetes, kidney disorders, allergy to the ginger root, voiding drugs for corticosteroid, nausea and vomiting, and no history of smoking. A total of 80 patients were randomly selected to undergo eye surgery, meeting the criteria and being willing to participate in the study. The study design was based on the consort 2010 flow diagram (
Figure 1). Samples and medical consent were taken based on ethical code 101568 from the Iran University of Medical Sciences (IUMS) and IRCT code 2014060918020N1 from www.irct.ir.
Ginger capsules (1000 mg) were prepared at a pharmacology lab and placeboes were made with identical shapes such that they could not be differentiated easily. Both ginger and placebo capsules were administered randomly. Patients were divided into two groups of A and B. Group A received a single ginger dose of 1000 mg and group B received a placebo with 30 mL water before surgery. Based on anesthesia expertise, conditions such as medication type, administration, and duration of anesthesia were the same among all participants. The medication of anesthesia induction included midazolam 2 mg, fentanyl 2 µg/kg, thiopental 5 mg/kg, and atracurium 0.5 mg/kg. Moreover, 50% oxygen, 50% N2O were used for the maintenance of anesthesia. We did not use medications that could cause nausea and vomiting such as morphine. Also, all patients received 500 mL of normal saline. Injectable ondansetron was used if patients needed anti-nausea medication.
To evaluate nausea, we used a 10 cm linear analog scale that ranged from 0 to 10; scores 0, 1 - 3, 4 - 6, 7 - 9, and 10 were assigned to no, mild, moderate, severe, and very severe nausea, respectively. Vomiting was defined as a severe gastrointestinal stimulation, which caused the forceful discharge of the contents of the digestive tract from the mouth (
20). The number of vomiting episodes was recorded (
21). Using a premade checklist, the severity and frequency of PONV were measured by an investigator, unaware of the treatment regimen, immediately, 15 min, 30 minutes, and 2 hours after recovery. Additionally, the vital signs included the heart rate, systolic and diastolic pressure, respiratory rate assessed 30 minutes before anesthesia induction and 30 minutes after recovery. All collected data were analyzed by SPSS V. 21, using a
t-test and chi-square test.