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

NCT ID: NCT04030884

Last Updated: 2019-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-03
• Study Completion Date: 2018-02-19

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.

Conditions

Postoperative Nausea and Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Intervention Lap.Chol.

Honey and water mixture was ingested up to two hours preoperatively by the participants who were going to have a laparoscopic cholecystectomy.

Group Type: EXPERIMENTAL

Honey and water mixture

Intervention Type: DIETARY_SUPPLEMENT

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.

Control Lap.Chol.

The participants received standard care for their laparoscopic cholecystectomy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention Thyroidectomy

Honey and water mixture was ingested up to two hours preoperatively by the participants who were going to have a thyroidectomy.

Group Type: EXPERIMENTAL

Honey and water mixture

Intervention Type: DIETARY_SUPPLEMENT

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.

Control Thyroidectomy

The participants received standard care for their thyroidectomy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OYA GUMUSKAYA BRADLEY

OTHER

Sponsor Role: lead

Responsible Party

OYA GUMUSKAYA BRADLEY

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

OYA GUMUSKAYA, PhD

Role: PRINCIPAL_INVESTIGATOR

Yeditepe University

Locations

Istanbul University-Cerrahpasa

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

03/05/2017-166977

Identifier Type: -

Identifier Source: org_study_id