The Effect of Oral Honey and Water Up to Two Hours Before Surgery on Postoperative Nausea and Vomiting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- The Comparison of R-INVR Average Scores by the Intervention and Control groups
研究概览
简要总结
Postoperative nausea and vomiting (PONV) remains current as a complication and moderate evidence is available regarding the impact of preoperative oral carbohydrate-fluid administration on PONV. Honey, a natural source of carbohydrates, has an antioxidative effect and protects the gastric mucosa.
Aim: To investigate the effect of oral honey and water for up to 2 hours preoperatively on PONV.
Methods: A total of 142 elective thyroidectomy (experiment:35; control:37) and laparoscopic cholecystectomy (experiment:33; control: 37) patients were included. The experiment group was administered a 60 grams honey and 100 ml water mixture up to 2 hours preoperatively. The patients were monitored postoperative 0-6 hours using Rhodes Index of Nausea-Vomiting-Retching (R-INVR) and visual analog scale (VAS) for PONV.
详细描述
The American Society of PeriAnesthesiology Nurses (ASPAN) describes postoperative nausea and vomiting (PONV) as nausea and vomiting within the first 24 hours after an operation and early PONV for the first six hours. PONV is a frequent complication of surgical stress, extended fasting period and anaesthetic agents and has reported in 30% to 45% of patients, up to 80% of the patients at risk groups; especially for people who has gastrointestinal or major surgical procedures. Overall, one third of all patients who undergone a surgical intervention are said to experience PONV.
PONV causes discomfort, which may increase anxiety, and can induce indirect or direct pain in the individual. This may lead to an increase in intra-abdominal pressure, central venous pressure, blood pressure and intracranial pressure, increased risk of cardiac rhythm disturbances, and it can lead up to other complications such as risk of aspiration, a stretching of the incision. Therefore, the study was planned to evaluate as many variables as possible that affect PONV with the use of honey as a source of carbohydrate for the carbohydrate solutions (CS). By doing so, supplying carbohydrate to patients with a daily source of natural nutrient with its additional benefits of gastric mucosal protection was expected to decrease PONV. Honey has been widely used for its medicinal purposes for centuries and is suggested for daily intake for gastric protection. It was proved as an effective wound care material and rodent studies have showed outstanding results on gastric mucosa and ulcer treatment.
Hypothesis:
H1. The risk of PONV decreases with honey and water consumption in immediate preoperative period.
H2. Blood sugar level (BGL) is regulated as the fasting period is shortened in patients who receive honey orally.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants were blinded regarding which gastrointestinal complication was going to be evaluated after the surgery. Participants were informed that the intervention was for postoperative gastrointestinal comfort, without nausea and vomiting being mentioned in order to avoid psychological leading to PONV.
The nurses who collected the data were blinded for the group information (intervention or control) though they were informed the days of participant allocation (each morning they were informed that the current operating list included participants) for the proper use of the data collection forms.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals who volunteered to participate in the study
- •Individuals who have the ability to make decisions
- •Thyroidectomy operation
- •Laparoscopic cholecystectomy (Lap. Chol.) operation
- •Individuals who score 2/5 or more out of the Koivuranta PONV risk factors*
排除标准
- •Patients with diabetes,
- •Nothing by mouth patients (for other reasons than surgery),
- •Gastrointestinal system surgery patients
- •Individuals with pollen allergy
- •Koivuranta PONV risk factors:
- •Female gender, Non-smoking individuals History of PONV History of motion sickness Anesthesia duration
结局指标
主要结局
The Comparison of R-INVR Average Scores by the Intervention and Control groups
时间窗: Early postoperative period; 0-6 hours after surgery
R-INVR scale averaged scores were compared in groups (control, intervention); higher score indicates worse nausea and/or vomiting within the group.
PONV Occurence in all Participants by Rhodes Index of Nausea, Vomiting and Retching(R-INVR) Scores (8 items; each 0-4 points;total of 0-32 points)
时间窗: Early postoperative period; 0-6 hours after surgery
PONV measure; Any score above zero (\>0) indicates that participant experienced nausea. Each response is scored as 0: minimum, 4: maximum disturbance, and the score from 8 items was summed. The worst PONV experience can be expressed with the highest value of 32 points. 3 subscales were "experience, occurence, and distress". Experience (total experience score; 32): Nausea Experience Questions: 4,5,7; Total score; 0-12 Vomiting Experience Questions: 1,3,6; Total score; 0-12 Retching Experience Questions: 2,8; Total score; 0-8 Occurence (total occurence score; 20): Nausea Occurence Questions: 4,7; Total score; 0-8 Vomiting Occurence Questions: 1, 6; Total score; 0-8 Retching Occurence Questions: 8; Total score; 0-4 Distress (total occurence score; 12): Nausea Distress Questions: 5; Total score; 0-4 Vomiting Distress Questions: 3; Total score; 0-4 Retching Distress Questions: 2; Total score; 0-4
The Comparison of PONV Occurence by total R-INVR Scores in the Intervention and Control Groups
时间窗: Early postoperative period; 0-6 hours after surgery
PONV measure; Any R-INVR total score above zero (\>0) indicates that participant experienced nausea. This results were compared in control and intervention groups.
The Comparison of PONV Intensity by Total score of R-INVR (0-32 points) in the Intervention and Control Groups
时间窗: Early postoperative period; 0-6 hours after surgery
R-INVR scale total score was summed; higher points indicate worse nausea and/or vomiting Each response is scored between 0 to 4, and the score from 8 items were summed. The worst PONV experience can be expressed with the highest value of 32 points. These scores were compared in control and intervention groups and analysed.
The Comparison Between R-INVR Average Scores in the Intervention and Control Groups
时间窗: Early postoperative period; 0-6 hours after surgery
R-INVR scale total score was averaged in groups (total score0-32 points by 8 items each 0-4 points) (control, intervention); higher score indicates worse nausea and/or vomiting within the group
Visual Analog Scale (VAS) (0-10 points) for PONV
时间窗: Early postoperative period; 0-6 hours after surgery
The level of experienced nausea and vomiting described by participants and nurses using VAS; 10 indicates the worst experience of nausea and/or vomiting; and 0, no nausea or vomiting being experienced
次要结局
- Anesthesia duration by minutes (marked as sign in and time out) and PONV occurence (R-INVR total score) comparison(Early postoperative period; 0-6 hours after surgery)
- The Comparison of intraoperative Intravenous Ondansetron and PONV occurence (R-INVR total score >0) in All Participants(Early postoperative period; 0-6 hours after surgery)
- The Comparison of intraoperative Intravenous Ondansetron and PONV occurence (R-INVR total score >0) in All Participants in the Intervention and Control Groups(Early postoperative period; 0-6 hours after surgery)
- The Comparison of the Intensity of PONV Occurence in PONV risk groups (not smoking, women, age <50, over one hour anesthesia, previous experience of PONV or motion sickness) by the total R-INVR scores(Early postoperative period; 0-6 hours after surgery)
- Gender (men or women) and PONV relation(Early postoperative period; 0-6 hours after surgery)
- Age over and below 50 and PONV relation(Early postoperative period; 0-6 hours after surgery)
- The Comparison of Smoking status (smoking or not smoking) of Participants in the Intervention and Control Groups was compared with PONV occurence (R-INVR total score)(Early postoperative period; 0-6 hours after surgery)
- Age and PONV relation(Early postoperative period; 0-6 hours after surgery)
研究者
OYA GUMUSKAYA BRADLEY
Assistant Professor
Istanbul University - Cerrahpasa