Postoperative Nausea and VomitingPONVNCT04030884
The Effect of Oral Honey and Water Up to Two Hours Before Surgery on Postoperative Nausea and Vomiting
A study testing Honey and water mixture in people with Postoperative Nausea and Vomiting, run by OYA GUMUSKAYA BRADLEY at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Honey and water mixture
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 May 2017to 19 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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*
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul, 34098
About this study
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.
Read the 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.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Honey and water mixture
- Keywords
- postoperative nausea and vomiting, nursing, oral carbohydrate, honey
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Honey and water mixtureDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Lap.Chol. | Experimental | Honey and water mixture was ingested up to two hours preoperatively by the participants who were going to have a laparoscopic cholecystectomy. Receives: Dietary Supplement: Honey and water mixture |
| Control Lap.Chol. | No intervention | The participants received standard care for their laparoscopic cholecystectomy. |
| Intervention Thyroidectomy | Experimental | Honey and water mixture was ingested up to two hours preoperatively by the participants who were going to have a thyroidectomy. Receives: Dietary Supplement: Honey and water mixture |
| Control Thyroidectomy | No intervention | The participants received standard care for their thyroidectomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Early postoperative period; 0-6 hours after surgery
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.
Measured: Early postoperative period; 0-6 hours after surgery
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.
Measured: Early postoperative period; 0-6 hours after surgery
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
Measured: Early postoperative period; 0-6 hours after surgery
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.
Measured: Early postoperative period; 0-6 hours after surgery
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
Measured: Early postoperative period; 0-6 hours after surgery
Secondary outcomes (8)
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)
Measured: 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)
People who do not smoke (tobacco) is proved to be under risk for PONV and this status was compared with R-INVR total score.
Measured: 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
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)
Measured: 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
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
Measured: 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
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)
Measured: Early postoperative period; 0-6 hours after surgery
Gender (men or women) and PONV relation
Woman gender is a described risk factor for PONV and R-INVR results by gender were comprised.
Measured: Early postoperative period; 0-6 hours after surgery
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.
Measured: Early postoperative period; 0-6 hours after surgery
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.
Measured: Early postoperative period; 0-6 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start3 May 2017
- Primary completion9 Jan 2018
- Study completion19 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with two types of surgery compared, each consisting intervention and control groups.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- OYA GUMUSKAYA BRADLEY
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, OYA GUMUSKAYA BRADLEY, Istanbul University - Cerrahpasa
- Investigators
- OYA GUMUSKAYA, PhD, Principal investigator, Yeditepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04030884
- Sponsor's protocol ID
- 03/05/2017-166977
- Acronym
- PONV
- Status last verified
- Jul 2019
- First submitted
- 8 Jul 2019
- Last updated
- 25 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The raw data will be available after consensus reached within investigators regarding publication and following publication of all study results.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Honey and Water Up to Two Hours Before Surgery on Postoperative Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT04030884
- Acronym / sponsor ID
- PONV / 03/05/2017-166977
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- postoperative nausea and vomiting, nursing, oral carbohydrate, honey
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- OYA GUMUSKAYA BRADLEYUniversity, hospital or other
- Study start
- 3 May 2017 (actual)
- Primary completion
- 9 Jan 2018 (actual)
- Study completion
- 19 Feb 2018 (actual)
- First posted
- 24 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized controlled trial with two types of surgery compared, each consisting intervention and control groups.
| Arm | Type | Receives |
|---|---|---|
| Intervention Lap.Chol. | Experimental | Dietary Supplement: Honey and water mixtureHoney and water mixture was ingested up to two hours preoperatively by the participants who were going to have a laparoscopic cholecystectomy. |
| Control Lap.Chol. | No intervention | –The participants received standard care for their laparoscopic cholecystectomy. |
| Intervention Thyroidectomy | Experimental | Dietary Supplement: Honey and water mixtureHoney and water mixture was ingested up to two hours preoperatively by the participants who were going to have a thyroidectomy. |
| Control Thyroidectomy | No intervention | –The participants received standard care for their thyroidectomy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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*
Key exclusion criteria (6 listed)
- Patients with diabetes,
- Nothing by mouth patients (for other reasons than surgery),
- Gastrointestinal system surgery patients
- Individuals with pollen allergy
- Female gender, Non-smoking individuals History of PONV History of motion sickness Anesthesia duration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Honey and water mixture60 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. | Dietary supplement | Intervention Lap.Chol., Intervention Thyroidectomy |
Primary outcome
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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
The Comparison of R-INVR Average Scores by the Intervention and Control groups
Time frame: 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.
Visual Analog Scale (VAS) (0-10 points) for PONV
Time frame: 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
8 secondary outcomes
Anesthesia duration by minutes (marked as sign in and time out) and PONV occurence (R-INVR total score) comparison
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Early postoperative period; 0-6 hours after surgery
Gender (men or women) and PONV relation
Time frame: Early postoperative period; 0-6 hours after surgery
Age and PONV relation
Time frame: Early postoperative period; 0-6 hours after surgery
Age over and below 50 and PONV relation
Time frame: Early postoperative period; 0-6 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2019.
- Individual participant dataSharing planned: Yes. The raw data will be available after consensus reached within investigators regarding publication and following publication of all study results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
OYA GUMUSKAYA, PhD principal investigator
Yeditepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Honey and water mixture in people with Postoperative Nausea and Vomiting, run by OYA GUMUSKAYA BRADLEY at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: Early postoperative period; 0-6 hours after surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2019.