Postoperative Nausea and VomitingNCT04538300
Treatment of Postoperative Nausea-Vomiting in Laparoscopic Cholecystectomy: Peppermint-Flavored Gum Versus Gum-Free
A study testing Abramowitz Emesis Score, Degree of nausea and Observer's Assessment of Alertness/Sedation Scale in people with Postoperative Nausea and Vomiting and Chewing Gum, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Nausea and Vomiting, Chewing Gum
- What is being tested?
- Abramowitz Emesis Score, Degree of nausea and Observer's Assessment of Alertness/Sedation Scale
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2017to 3 May 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergone for elective laparoscopic cholecystectomy under general anaesthesia
- American Society of Anesthesiologist (ASA) I-II
- Patients between the ages of 18-65
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Yuksek Ihtisas Education and Research Hospital
Bursa, 16310
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Nausea and Vomiting, Chewing Gum
- Being tested
- Abramowitz Emesis Score, Degree of nausea, Observer's Assessment of Alertness/Sedation Scale, Patient Satisfaction, Surgeon Satisfaction
- Keywords
- Postoperative Nausea and Vomiting, Chewing gum, Ondansetron
- 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.
Abramowitz Emesis ScoreDiagnostic test
Postoperative vomiting was evaluated by Abramowitz emesis score in recovery room.
Degree of nauseaDiagnostic test
Degree of postoperative nausea was evaluated.
Observer's Assessment of Alertness/Sedation ScaleDiagnostic test
Patients' sufficient wakefulness was evaluated by Observer's Assessment of Alertness/Sedation scale in the recovery unit.
Patient SatisfactionDiagnostic test
Patient satisfaction was questioned. Answers were recorded as one of the choices (never, sometimes, usually or always)
Surgeon SatisfactionDiagnostic test
Surgeon satisfaction was questioned. Answers were recorded as one of the choices (never, sometimes, usually or always)
Chewing Peppermint gumOther
Peppermint gum was chewed for 15 minutes in patients with sufficient wakefullness.
| Study group | Role | What they receive |
|---|---|---|
| Group Gum | Active comparator | 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. Receives: Diagnostic Test: Abramowitz Emesis Score; Diagnostic Test: Degree of nausea; Diagnostic Test: Observer's Assessment of Alertness/Sedation Scale; Diagnostic Test: Patient Satisfaction; Diagnostic Test: Surgeon Satisfaction; Other: Chewing Peppermint gum |
| Group Control | Active comparator | 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. Receives: Diagnostic Test: Abramowitz Emesis Score; Diagnostic Test: Degree of nausea; Diagnostic Test: Observer's Assessment of Alertness/Sedation Scale; Diagnostic Test: Patient Satisfaction; Diagnostic Test: Surgeon Satisfaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of nausea
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.
Measured: 24 hours
Emesis
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.
Measured: 24 hours
Secondary outcomes (3)
Antiemetic requirement
Antiemetic drugs were given if nausea score was bigger than 3 and Abramowitz emesis scorewas bigger than 1.
Measured: 24 hours
Patient Satisfaction
Patient satisfaction was questioned. Answers were recorded as one of the choices (0=never, 1=sometimes, 2=usually or 3=always)
Measured: 24 hours
Surgeon Satisfaction
Surgeon satisfaction was questioned. Answers were recorded as one of the choices (0=never, 1=sometimes, 2=usually or 3=always)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start1 May 2017
- Primary completion1 May 2018
- Study completion3 May 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 300 patients ASA I-II, aged between18-65 years who scheduled for elective laparoscopic cholecystectomy under general anesthesia were included. The patients randomly divided into 2 groups (Group G n=150, Group C n=150) with the closed envelope method. In group G peppermint-flavored gum was chewed for 15 minutes in patients with sufficient wakefullness. If PONV persists despite gumming twice, ondansetron iv 4 mg, dexamethasone iv 4 mg, propofol iv 10 mg were given respectively. Patients with moderate and severe nausea in the control group(Group C) were given iv 4 mg ondansetron. If PONV continues, it was planned to give dexamethasone iv 4 mg and propofol iv 10 mg, respectively. In group C(control) degree of nausea and Abramowitz Emezis score were evaluated.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Canan Yılmaz, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Canan Yılmaz, Principal investigator, Medical Doctor of Anesthesiology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538300
- Sponsor's protocol ID
- 2017-5/35
- Status last verified
- Sep 2020
- First submitted
- 26 Aug 2020
- Last updated
- 7 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Chewing Gum on Treatment of Postoperative Nausea-vomiting in Laparoscopic Cholecystectomy: Prospective, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT04538300
- Acronym / sponsor ID
- 2017-5/35
- Conditions
- Postoperative Nausea and Vomiting, Chewing Gum
- Keywords
- Postoperative Nausea and Vomiting, Chewing gum, Ondansetron
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 3 May 2018 (actual)
- First posted
- 4 Sep 2020 (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) 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 300 patients ASA I-II, aged between18-65 years who scheduled for elective laparoscopic cholecystectomy under general anesthesia were included. The patients randomly divided into 2 groups (Group G n=150, Group C n=150) with the closed envelope method. In group G peppermint-flavored gum was chewed for 15 minutes in patients with sufficient wakefullness. If PONV persists despite gumming twice, ondansetron iv 4 mg, dexamethasone iv 4 mg, propofol iv 10 mg were given respectively. Patients with moderate and severe nausea in the control group(Group C) were given iv 4 mg ondansetron. If PONV continues, it was planned to give dexamethasone iv 4 mg and propofol iv 10 mg, respectively. In group C(control) degree of nausea and Abramowitz Emezis score were evaluated.
| Arm | Type | Receives |
|---|---|---|
| Group Gum | Active comparator | Diagnostic Test: Abramowitz Emesis Score, Diagnostic Test: Degree of nausea, Diagnostic Test: Observer's Assessment of Alertness/Sedation Scale, Diagnostic Test: Patient Satisfaction, Diagnostic Test: Surgeon Satisfaction, Other: Chewing Peppermint gumPeppermint 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. |
| Group Control | Active comparator | Diagnostic Test: Abramowitz Emesis Score, Diagnostic Test: Degree of nausea, Diagnostic Test: Observer's Assessment of Alertness/Sedation Scale, Diagnostic Test: Patient Satisfaction, Diagnostic Test: Surgeon SatisfactionIn 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- undergone for elective laparoscopic cholecystectomy under general anaesthesia
- American Society of Anesthesiologist (ASA) I-II
- Patients between the ages of 18-65
Key exclusion criteria (7 listed)
- 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,
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 |
|---|---|---|
| Abramowitz Emesis ScorePostoperative vomiting was evaluated by Abramowitz emesis score in recovery room. | Diagnostic test | Group Control, Group Gum |
| Degree of nauseaDegree of postoperative nausea was evaluated. | Diagnostic test | Group Control, Group Gum |
| Observer's Assessment of Alertness/Sedation ScalePatients' sufficient wakefulness was evaluated by Observer's Assessment of Alertness/Sedation scale in the recovery unit. | Diagnostic test | Group Control, Group Gum |
| Patient SatisfactionPatient satisfaction was questioned. Answers were recorded as one of the choices (never, sometimes, usually or always) | Diagnostic test | Group Control, Group Gum |
| Surgeon SatisfactionSurgeon satisfaction was questioned. Answers were recorded as one of the choices (never, sometimes, usually or always) | Diagnostic test | Group Control, Group Gum |
| Chewing Peppermint gumPeppermint gum was chewed for 15 minutes in patients with sufficient wakefullness. | Other | Group Gum |
Primary outcome
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.
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.
3 secondary outcomes
Antiemetic requirement
Time frame: 24 hours
Patient Satisfaction
Time frame: 24 hours
Surgeon Satisfaction
Time frame: 24 hours
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 7 Sep 2020.
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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.
Canan Yılmaz principal investigator
Medical Doctor of Anesthesiology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abramowitz Emesis Score, Degree of nausea and Observer's Assessment of Alertness/Sedation Scale in people with Postoperative Nausea and Vomiting and Chewing Gum, run by Bursa Yuksek Ihtisas Training and Research Hospital 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 3 inclusion and 7 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 7 Sep 2020. 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?
Degree of nausea (time frame: 24 hours). The study lists 2 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 7 Sep 2020.