The Effect of Oral Honey and Water Up to Two Hours Before Surgery on Postoperative Nausea and Vomiting

Postoperative Nausea and Vomiting Clinical Trial

— PONV  

Official title:

The Effect of Oral Honey and Water Up to Two Hours Before Surgery on Postoperative Nausea and Vomiting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04030884
• Other study ID #: 03/05/2017-166977
• Status: Completed
• Phase: N/A
• Start date: May 3, 2017
• Est. completion date: February 19, 2018

Study information

• Verified date: July 2019
• Source: Istanbul University-Cerrahpasa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Intervention:

The experiment group received 60 g honey in a 190 ml food grade empty glass jars which were topped with 100 ml room temperature drinking water and mixed. For standardization of the honey content, Turkish Black Chestnut Honey were purchased from a registered producer. The honey then was sent to be tested for safety and quality analysis and has found to be within the acceptable quality limits of international standards. This information was shared with participants.

The experiment and the control group both were observed for the first 6 hours after surgery by the post anaesthesia care unit (PACU) and ward nurses who were blinded to the group information.

Data Collection A data collection form consisting of 23 questions and sub-items including participants' demographics and questioning the risk of nausea and vomiting was prepared according to the related literature.

Data collection form;

1. The demographic chapter comprises; age, gender, educational status, height, weight, body mass index, general health status, allergies

2. Planned surgical intervention and anaesthesia applications; surgery, type and the duration of anaesthesia, anaesthetic agents,

3. Nausea and vomiting risk assessment questions of Koivuranta scale; age, gender, smoking status, previous nausea vomiting experience, the duration of anaesthesia,

4. Post-operative period; complications, a two-hour postoperative pain visual analogue scale (VAS), blood sugar levels, drugs for nausea and vomiting,

5. VAS and Rhodes Index of Nausea, Vomiting and Retching (R-INVR) to examine PONV. The Index of Nausea Vomiting and Retching was developed by Rhodes and McDaniel and adaptation, validity and reliability in Turkish population of the scale was carried out by Tan and Genç (2010).

The Statistical Analysis:

The statistical analysis was performed using IBM SPSS 21.0 (IBM Corp. released 2012, Armonk, NewYork, USA). Descriptive statistics; mean, standard deviation, median, smallest-largest, frequency, percent. In the comparison of discrete variables; Pearson's chi-square and Fisher's exact test were used. The suitability of continuous variables to normal distribution was evaluated by Kolmogorov Smirnov test. Intergroup comparisons of continuous variables were performed by Kruskal Wallis, independent samples t test and Mann Whitney U test. Bonferroni corrected Mann Whitney U test was used in paired group comparisons (post hoc) when the results of Kruskal Wallis test were meaningful. Intra-group comparisons were performed with t test in dependent groups. Pearson and Spearman correlation tests were used to evaluate the linear relationship between the variables. A p value of <0.05 was accepted for statistical significance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: February 19, 2018
• Est. primary completion date: January 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria

• 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*

Exclusion Criteria

• 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

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Dietary Supplement:
• Honey and water mixture
60 gr of organic Turkish BlackSea Region Chestnut Honey and 100 ml Spring water mixture both mixed in room temperature and ingested up to two hours before the surgery by participants who were "nill by mouth" from midnight prior to the operation day.

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrahpasa	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
OYA GUMUSKAYA BRADLEY

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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	Early postoperative period; 0-6 hours after surgery
Primary	The Comparison of PONV Occurence by total R-INVR Scores in the Intervention and Control Groups	PONV measure; Any R-INVR total score above zero (>0) indicates that participant experienced nausea. This results were compared in control and intervention groups.	Early postoperative period; 0-6 hours after surgery
Primary	The Comparison of PONV Intensity by Total score of R-INVR (0-32 points) in the Intervention and Control Groups	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.	Early postoperative period; 0-6 hours after surgery
Primary	The Comparison Between R-INVR Average Scores in the Intervention and Control Groups	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	Early postoperative period; 0-6 hours after surgery
Primary	The Comparison of R-INVR Average Scores by the Intervention and Control groups	R-INVR scale averaged scores were compared in groups (control, intervention); higher score indicates worse nausea and/or vomiting within the group.	Early postoperative period; 0-6 hours after surgery
Primary	Visual Analog Scale (VAS) (0-10 points) for PONV	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	Early postoperative period; 0-6 hours after surgery
Secondary	Anesthesia duration by minutes (marked as sign in and time out) and PONV occurence (R-INVR total score) comparison	Anesthesia duration (by minutes; defined risk factor) was compared with PONV occurence (measured with total R-INVR score)	Early postoperative period; 0-6 hours after surgery
Secondary	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)	People who do not smoke (tobacco) is proved to be under risk for PONV and this status was compared with R-INVR total score.	Early postoperative period; 0-6 hours after surgery
Secondary	The Comparison of intraoperative Intravenous Ondansetron and PONV occurence (R-INVR total score >0) in All Participants	Ondansetron use (by patient who received (4 or 8 mg IV during surgery, the dose was determined by anesthesia residents depending on patients' weight, verses patients who did not receive any ondansetron at all during surgery) was analysed against PONV occurence (R-INVR total score>0 or 0)	Early postoperative period; 0-6 hours after surgery
Secondary	The Comparison of intraoperative Intravenous Ondansetron and PONV occurence (R-INVR total score >0) in All Participants in the Intervention and Control Groups	Ondansetron use (by patient who received (4 or 8 mg IV during surgery, the dose was determined by anesthesia residents depending on patients' weight, verses patients who did not receive any ondansetron at all during surgery) was compared by PONV occurence (R-INVR total score>0 or 0) in control and intervention groups	Early postoperative period; 0-6 hours after surgery
Secondary	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	The intensity of experienced PONV measured by the total score of R-INVR was analysed according to risk factors (not smoking, women, age <50, over one hour anesthesia, previous experience of PONV or motion sickness)	Early postoperative period; 0-6 hours after surgery
Secondary	Gender (men or women) and PONV relation	Woman gender is a described risk factor for PONV and R-INVR results by gender were comprised.	Early postoperative period; 0-6 hours after surgery
Secondary	Age and PONV relation	Younger age is a described risk factor for PONV and R-INVR results for PONV were analysed for a relation between R-INVR scores with participants' age. A linear relation was analysed if the R-INVR scores declined by age or not.	Early postoperative period; 0-6 hours after surgery
Secondary	Age over and below 50 and PONV relation	The participants' data was divided in two according to age by being over or below 50 years; this was a described risk factor and R-INVR total scores were analysed for a relation between PONV and participants' age.	Early postoperative period; 0-6 hours after surgery