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

Primary Purpose

Postoperative Nausea and Vomiting

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Honey and water mixture
Sponsored by
OYA GUMUSKAYA BRADLEY
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Nausea and Vomiting focused on measuring postoperative nausea and vomiting, nursing, oral carbohydrate, honey

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul University-Cerrahpasa

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

Intervention Lap.Chol.

Control Lap.Chol.

Intervention Thyroidectomy

Control Thyroidectomy

Arm Description

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

The participants received standard care for their laparoscopic cholecystectomy.

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

The participants received standard care for their thyroidectomy.

Outcomes

Primary Outcome Measures

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
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.
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.
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
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.
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

Secondary Outcome Measures

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)
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.
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)
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
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)
Gender (men or women) and PONV relation
Woman gender is a described risk factor for PONV and R-INVR results by gender were comprised.
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.
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.

Full Information

First Posted
July 8, 2019
Last Updated
July 23, 2019
Sponsor
OYA GUMUSKAYA BRADLEY
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1. Study Identification

Unique Protocol Identification Number
NCT04030884
Brief Title
The Effect of Oral Honey and Water Up to Two Hours Before Surgery on Postoperative Nausea and Vomiting
Acronym
PONV
Official Title
The Effect of Oral Honey and Water Up to Two Hours Before Surgery on Postoperative Nausea and Vomiting
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
May 3, 2017 (Actual)
Primary Completion Date
January 9, 2018 (Actual)
Study Completion Date
February 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
OYA GUMUSKAYA BRADLEY

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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; The demographic chapter comprises; age, gender, educational status, height, weight, body mass index, general health status, allergies Planned surgical intervention and anaesthesia applications; surgery, type and the duration of anaesthesia, anaesthetic agents, Nausea and vomiting risk assessment questions of Koivuranta scale; age, gender, smoking status, previous nausea vomiting experience, the duration of anaesthesia, Post-operative period; complications, a two-hour postoperative pain visual analogue scale (VAS), blood sugar levels, drugs for nausea and vomiting, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting
Keywords
postoperative nausea and vomiting, nursing, oral carbohydrate, honey

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial with two types of surgery compared, each consisting intervention and control groups.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Lap.Chol.
Arm Type
Experimental
Arm Description
Honey and water mixture was ingested up to two hours preoperatively by the participants who were going to have a laparoscopic cholecystectomy.
Arm Title
Control Lap.Chol.
Arm Type
No Intervention
Arm Description
The participants received standard care for their laparoscopic cholecystectomy.
Arm Title
Intervention Thyroidectomy
Arm Type
Experimental
Arm Description
Honey and water mixture was ingested up to two hours preoperatively by the participants who were going to have a thyroidectomy.
Arm Title
Control Thyroidectomy
Arm Type
No Intervention
Arm Description
The participants received standard care for their thyroidectomy.
Intervention Type
Dietary Supplement
Intervention Name(s)
Honey and water mixture
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Description
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
Time Frame
Early postoperative period; 0-6 hours after surgery
Title
The Comparison of PONV Occurence by total R-INVR Scores in the Intervention and Control Groups
Description
PONV measure; Any R-INVR total score above zero (>0) indicates that participant experienced nausea. This results were compared in control and intervention groups.
Time Frame
Early postoperative period; 0-6 hours after surgery
Title
The Comparison of PONV Intensity by Total score of R-INVR (0-32 points) in the Intervention and Control Groups
Description
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.
Time Frame
Early postoperative period; 0-6 hours after surgery
Title
The Comparison Between R-INVR Average Scores in the Intervention and Control Groups
Description
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
Time Frame
Early postoperative period; 0-6 hours after surgery
Title
The Comparison of R-INVR Average Scores by the Intervention and Control groups
Description
R-INVR scale averaged scores were compared in groups (control, intervention); higher score indicates worse nausea and/or vomiting within the group.
Time Frame
Early postoperative period; 0-6 hours after surgery
Title
Visual Analog Scale (VAS) (0-10 points) for PONV
Description
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
Time Frame
Early postoperative period; 0-6 hours after surgery
Secondary Outcome Measure Information:
Title
Anesthesia duration by minutes (marked as sign in and time out) and PONV occurence (R-INVR total score) comparison
Description
Anesthesia duration (by minutes; defined risk factor) was compared with PONV occurence (measured with total R-INVR score)
Time Frame
Early postoperative period; 0-6 hours after surgery
Title
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)
Description
People who do not smoke (tobacco) is proved to be under risk for PONV and this status was compared with R-INVR total score.
Time Frame
Early postoperative period; 0-6 hours after surgery
Title
The Comparison of intraoperative Intravenous Ondansetron and PONV occurence (R-INVR total score >0) in All Participants
Description
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)
Time Frame
Early postoperative period; 0-6 hours after surgery
Title
The Comparison of intraoperative Intravenous Ondansetron and PONV occurence (R-INVR total score >0) in All Participants in the Intervention and Control Groups
Description
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
Time Frame
Early postoperative period; 0-6 hours after surgery
Title
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
Description
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)
Time Frame
Early postoperative period; 0-6 hours after surgery
Title
Gender (men or women) and PONV relation
Description
Woman gender is a described risk factor for PONV and R-INVR results by gender were comprised.
Time Frame
Early postoperative period; 0-6 hours after surgery
Title
Age and PONV relation
Description
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.
Time Frame
Early postoperative period; 0-6 hours after surgery
Title
Age over and below 50 and PONV relation
Description
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.
Time Frame
Early postoperative period; 0-6 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
OYA GUMUSKAYA, PhD
Organizational Affiliation
Yeditepe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University-Cerrahpasa
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The raw data will be available after consensus reached within investigators regarding publication and following publication of all study results.
IPD Sharing Time Frame
Within 2 years from publication of all results.
IPD Sharing Access Criteria
Contact to investigators.

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

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