Postoperative Nausea and Vomiting Clinical Trial
Official title:
The Effect of Oral Honey and Water Up to Two Hours Before Surgery on Postoperative Nausea and Vomiting
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04466046 -
The Effect on Anxiolytics With Type of Antiemetic Agents on Postoperative Nausea and Vomiting in High Risk Patients
|
||
Completed |
NCT03139383 -
Dextrose Containing Fluid and the Postoperative Nausea and Vomiting in the Gynecologic Laparoscopic Surgery
|
N/A | |
Recruiting |
NCT04069806 -
Preoperative Oral Carbohydrate for Nausea and Vomiting Prevention During Cesarian Section
|
N/A | |
Completed |
NCT04043247 -
Transcutaneous Electrical Acupoint Stimulation for Prevention of Postoperative Nausea and Vomiting
|
N/A | |
Terminated |
NCT01975727 -
Dexamethasone for the Treatment of Established Postoperative Nausea and Vomiting
|
Phase 2 | |
Completed |
NCT03662672 -
Rib Raising for Post-operative Ileus
|
N/A | |
Completed |
NCT00090155 -
2 Doses of an Approved Drug Being Studied for a New Indication for the Prevention of Postoperative Nausea and Vomiting (0869-090)(COMPLETED)
|
Phase 3 | |
Recruiting |
NCT05375721 -
Prevention of PONV With Traditional Chinese Medicine
|
N/A | |
Completed |
NCT02480088 -
Comparison of Palonosetron and Ramosetron for Preventing Patient-controlled Analgesia Related Nausea and Vomiting Following Spine Surgery; Association With ABCB1 Polymorphism
|
Phase 4 | |
Recruiting |
NCT06137027 -
Cannabidiol Oil Extract for Prevention of Postoperative Nausea and Vomiting
|
Early Phase 1 | |
Not yet recruiting |
NCT05529004 -
A 6 Months Double Blind Trial to Prevent PONV in Laparoscopic Cholecystectomy
|
Phase 2 | |
Completed |
NCT02944942 -
Risk Factors for Postoperative Nausea/Vomiting
|
N/A | |
Recruiting |
NCT02571153 -
Low Doses of Ketamine and Postoperative Quality of Recovery
|
Phase 4 | |
Completed |
NCT02449291 -
Study of APD421 as PONV Treatment (no Prior Prophylaxis)
|
Phase 3 | |
Completed |
NCT02550795 -
Dexmedetomidine or Dexmedetomidine Combined With Dexamethasone on Postoperative Nausea and Vomiting in Breast Cancer
|
N/A | |
Recruiting |
NCT01442012 -
Utility of Acupuncture in the Treatment of Postoperative Nausea and Vomiting in Ambulatory Surgery
|
N/A | |
Completed |
NCT01478165 -
Comparison of TIVA (Total Intravenous Anesthesia) and TIVA Plus Palonosetron in Preventing Postoperative Nausea and Vomiting
|
N/A | |
Unknown status |
NCT01268748 -
Single Port Versus Four Ports Laparoscopic Cholecystectomy and Early Postoperative Pain
|
N/A | |
Completed |
NCT02143531 -
Intravenous Haloperidol Versus Ondansetron for Treatment of Established Post-operative Nausea and Vomiting
|
Phase 4 | |
Completed |
NCT00734929 -
Aprepitant With Dexamethasone Versus Ondansetron With Dexamethasone for PONV Prophylaxis in Patients Having Craniotomy
|
Phase 4 |