Clinical trial NCT04030884: The Effect of Oral Honey and Water Up to Two Hours Before Surgery on Postoperative Nausea and Vomiting
Official title: The Effect of Oral Honey and Water Up to Two Hours Before Surgery on Postoperative Nausea and Vomiting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Keywords: postoperative nausea and vomiting
nursing
oral carbohydrate
honey
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2019-07-24
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with two types of surgery compared, each consisting intervention and control groups.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: Early postoperative period; 0-6 hours after surgery
measure: The Comparison of PONV Occurence by total R-INVR Scores in the Intervention and Control Groups
timeFrame: Early postoperative period; 0-6 hours after surgery
measure: The Comparison of PONV Intensity by Total score of R-INVR (0-32 points) in the Intervention and Control Groups
timeFrame: Early postoperative period; 0-6 hours after surgery
measure: The Comparison Between R-INVR Average Scores in the Intervention and Control Groups
timeFrame: Early postoperative period; 0-6 hours after surgery
measure: The Comparison of R-INVR Average Scores by the Intervention and Control groups
timeFrame: Early postoperative period; 0-6 hours after surgery
measure: Visual Analog Scale (VAS) (0-10 points) for PONV
timeFrame: Early postoperative period; 0-6 hours after surgery
Secondary outcomes:
measure: Anesthesia duration by minutes (marked as sign in and time out) and PONV occurence (R-INVR total score) comparison
timeFrame: Early postoperative period; 0-6 hours after surgery
measure: 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)
timeFrame: Early postoperative period; 0-6 hours after surgery
measure: The Comparison of intraoperative Intravenous Ondansetron and PONV occurence (R-INVR total score >0) in All Participants
timeFrame: Early postoperative period; 0-6 hours after surgery
measure: The Comparison of intraoperative Intravenous Ondansetron and PONV occurence (R-INVR total score >0) in All Participants in the Intervention and Control Groups
timeFrame: Early postoperative period; 0-6 hours after surgery
measure: 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
timeFrame: Early postoperative period; 0-6 hours after surgery
measure: Gender (men or women) and PONV relation
timeFrame: Early postoperative period; 0-6 hours after surgery
measure: Age and PONV relation
timeFrame: Early postoperative period; 0-6 hours after surgery
measure: Age over and below 50 and PONV relation
timeFrame: Early postoperative period; 0-6 hours after surgery
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
affiliation: Yeditepe University
name: OYA GUMUSKAYA, PhD
role: PRINCIPAL_INVESTIGATOR
References: