- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04538300
Treatment of Postoperative Nausea-Vomiting in Laparoscopic Cholecystectomy: Peppermint-Flavored Gum Versus Gum-Free
September 3, 2020 updated by: Canan Yılmaz, Bursa Yüksek İhtisas Education and Research Hospital
Effect of Chewing Gum on Treatment of Postoperative Nausea-vomiting in Laparoscopic Cholecystectomy: Prospective, Randomized, Controlled Trial
Postoperative nausea and vomiting (PONV) is an unwanted and distressing complication for patients.
PONV affects one-third of untreated patients after general anesthesia.
PONV is a hard state for patients, surgeons, and anesthesiologists and increases the anxiety of patient.
There are many pharmacologic agents efficient in treatment and prophylaxis of PONV, however, these drugs have many side effects.
At the same time, there are many non-pharmacological strategies for antiemetic therapies.
Therefore there is an interest to nonpharmacologic agents.
Such as acupuncture, ginger, peppermint …etc.
Mint is a popular vegetable used as an antispasmodic, analgesic, antimicrobial and anti-vomiting treatment.
The use of mint is safe and no certain side-effects and interactions.
Chewing affects on postoperative bowel functions.
Our hypothesis was mint chewing gum is effective on treatment of PONV.
Laparoscopic cholecystectomy surgery has a high risk for PONV in adults.
In this study, our aim is to investigate the effect of mint gum chewing in the treatment of PONV in laparoscopic cholecystectomy surgery.
Study Overview
Status
Completed
Conditions
Detailed Description
The study protocol was approved by the Local Ethics Committee.
Written informed consent was obtained from each patient.
The study was carried out in accordance with The Code of Ethics of the Declaration of Helsinki.
300 patients ASA I-II, between18-65 years old, scheduled for elective laparoscopic cholecystectomy under general anesthesia were enrolled in the study.
Patients who have pharyngeal or esophageal dysfunction, significant cardiorespiratory dysfunction, phenylketonuria, inadequate to Turkish language comprehension, allergy to mint or antiemetic drugs, were not feasible to chew gum were excluded from the study.
All patients were routinely monitored (electrocardiography,SpO2,noninvasive blood pressure).
Demographic datas were recorded.
Anesthesia induction was made with propofol 2-3mg/kg iv, fentanyl 1.5mcg /kg iv and rocuronium 1mg / kg.
Anesthesia maintenance was provided with sevoflurane MAC 1.0 in 50% O2 and air mixture.
Intravenous10 mg metoclopromide, 50 mg ranitidine was given to all patients and sugammadex 2 mg/kg were administered for antagonism of neuromusculer block.
Before surgical incision paracetamol 1000 mg intravenous was given and 10 minutes before extubation diclofenac sodium 75 mg intramuscular was injected.At the end of surgery the patients were randomly divided into two groups.
Group G (Gum group) and Group C (Control group) with the closed envelope method.
Patients were followed up in the recovery unit for at least 30 minutes.
Degree of nausea and Abramowitz Emezis Score were evaluated for all the patients.
In Group G, peppermint gum was chewed for 15 minutes in patients with sufficient wakefulness (Observer's Assessment of Alertness/Sedation scale of 5).
The first gum application time was recorded.
If patient refused chewing gum, ondansetron iv 4mg was given.
If PONV repeated, chewing gum was given again.
If PONV was persisted despite chewing gum twice, ondansetron iv 4 mg, then dexamethasone iv 4 mg, propofol 20 mg iv slowly were given, respectively.
In Group C, ondansetron 4 mg iv was performed to patients whose postoperative nausea score was bigger than 3 and Abramowitz Emesis score one and above.
The first drug application time was recorded.
The time of PONV healed fully was recorded.
If PONV was continued, it was planned to give ondansetron 4mg iv, dexamethasone 4 mg iv and propofol iv 20 mg iv, respectively.
Nevertheless, it was planned to repeat ondansetron 0.15mg / kg at 4-hour intervals in patients whose PONV did not improve, with a total dose not exceeding 16mg.
The patients were followed up for 24 hours in terms of PONV.
In Group C, sufficient wakefulness was evaluated by Observer's Assessment of Alertness/Sedation scale of 5.If there is a complaint of PONV in the Surgical Service, the gum was given in Group G, then ondansetron 0.15 mg / kg and dexamethasone were given.
In Group C,ondansetron 0.15 mg / kg and dexamethasone were given.
Additional antiemetic needs, adverse events were recorded postoperatively 24 hours.
Patient and surgeon satisfaction were recorded for 24 hours.
Study Type
Interventional
Enrollment (Actual)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bursa, Turkey, 16310
- Bursa Yüksek İhtisas Education and Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- undergone for elective laparoscopic cholecystectomy under general anaesthesia
- American Society of Anesthesiologist (ASA) I-II
- Patients between the ages of 18-65
Exclusion Criteria:
- Patients who did not wish to participate in the study
- Patients who has pharyngeal or oesophagial disfunction
- Significant cardiorespiratory disfunction,
- Phenylketonuria,
- Inadequate to Turkish language comprehension,
- Allergy to mint or antiemetic drugs,
- Patients who was not feasible to chew gum were excluded from the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group Gum
Peppermint gum was chewed for 15 minutes in patients with sufficient wakefullness. Degree of nausea and Abramowitz Emezis score were evaluated as the interventions. If PONV persists second chewing gum was gived. 15 minutes later PONV was evaluated. If PONV was persisted ondansetron 4 mg, then dexamethasone 4 mg , then propofol 10 mg intravenously were given, respectively. |
Postoperative vomiting was evaluated by Abramowitz emesis score in recovery room.
Degree of postoperative nausea was evaluated.
Patients' sufficient wakefulness was evaluated by Observer's Assessment of Alertness/Sedation scale in the recovery unit.
Patient satisfaction was questioned.
Answers were recorded as one of the choices (never, sometimes, usually or always)
Surgeon satisfaction was questioned.
Answers were recorded as one of the choices (never, sometimes, usually or always)
Peppermint gum was chewed for 15 minutes in patients with sufficient wakefullness.
|
Active Comparator: Group Control
In Group Control, Degree of nausea and Abramowitz Emezis score were evaluated as the interventions in recovery room.
If patients with moderate and severe nausea were given 4 mg ondansetron intravenously.
If PONV continues, we planned to give dexamethasone 4 mg and propofol 10 mg intravenously, respectively.
|
Postoperative vomiting was evaluated by Abramowitz emesis score in recovery room.
Degree of postoperative nausea was evaluated.
Patients' sufficient wakefulness was evaluated by Observer's Assessment of Alertness/Sedation scale in the recovery unit.
Patient satisfaction was questioned.
Answers were recorded as one of the choices (never, sometimes, usually or always)
Surgeon satisfaction was questioned.
Answers were recorded as one of the choices (never, sometimes, usually or always)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Degree of nausea
Time Frame: 24 hours
|
Degree of nausea was evaluated as 0=none, 1-3=mild, 4-6=moderate or 7-10=severe.
The percentage of patients with mild, moderate or severe nausea were calculated.
And also, the percentage of patients without nausea were given.
|
24 hours
|
Emesis
Time Frame: 24 hours
|
I used Abramowitz Emesis score.
Abramowitz Emesis score was evaluated as 0=No vomiting, 1= slight vomiting (once times), 2=Moderate vomiting (two times), 3= severe vomiting (four times) or 4= Persistent vomiting (continuous).The percentage of patients with sligth, moderate, severe or persistent emesis were calculated.
And also, the percentage of patients without emesis were given.
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Antiemetic requirement
Time Frame: 24 hours
|
Antiemetic drugs were given if nausea score was bigger than 3 and Abramowitz emesis scorewas bigger than 1.
|
24 hours
|
Patient Satisfaction
Time Frame: 24 hours
|
Patient satisfaction was questioned.
Answers were recorded as one of the choices (0=never, 1=sometimes, 2=usually or 3=always)
|
24 hours
|
Surgeon Satisfaction
Time Frame: 24 hours
|
Surgeon satisfaction was questioned.
Answers were recorded as one of the choices (0=never, 1=sometimes, 2=usually or 3=always)
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Canan Yılmaz, Medical Doctor of Anesthesiology Department
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2017
Primary Completion (Actual)
May 1, 2018
Study Completion (Actual)
May 3, 2018
Study Registration Dates
First Submitted
August 26, 2020
First Submitted That Met QC Criteria
August 28, 2020
First Posted (Actual)
September 4, 2020
Study Record Updates
Last Update Posted (Actual)
September 7, 2020
Last Update Submitted That Met QC Criteria
September 3, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-5/35
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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