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Treatment of Postoperative Nausea-Vomiting in Laparoscopic Cholecystectomy: Peppermint-Flavored Gum Versus Gum-Free

Primary Purpose

Postoperative Nausea and Vomiting, Chewing Gum

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Abramowitz Emesis Score
Degree of nausea
Observer's Assessment of Alertness/Sedation Scale
Patient Satisfaction
Surgeon Satisfaction
Chewing Peppermint gum
Sponsored by
Bursa Yüksek İhtisas Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Nausea and Vomiting focused on measuring Postoperative Nausea and Vomiting, Chewing gum, Ondansetron

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bursa Yuksek Ihtisas Education and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group Gum

Group Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Antiemetic requirement
Antiemetic drugs were given if nausea score was bigger than 3 and Abramowitz emesis scorewas bigger than 1.
Patient Satisfaction
Patient satisfaction was questioned. Answers were recorded as one of the choices (0=never, 1=sometimes, 2=usually or 3=always)
Surgeon Satisfaction
Surgeon satisfaction was questioned. Answers were recorded as one of the choices (0=never, 1=sometimes, 2=usually or 3=always)

Full Information

First Posted
August 26, 2020
Last Updated
September 3, 2020
Sponsor
Bursa Yüksek İhtisas Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04538300
Brief Title
Treatment of Postoperative Nausea-Vomiting in Laparoscopic Cholecystectomy: Peppermint-Flavored Gum Versus Gum-Free
Official Title
Effect of Chewing Gum on Treatment of Postoperative Nausea-vomiting in Laparoscopic Cholecystectomy: Prospective, Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
May 3, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bursa Yüksek İhtisas Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting, Chewing Gum
Keywords
Postoperative Nausea and Vomiting, Chewing gum, Ondansetron

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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
Outcomes Assessor
Masking Description
When efficient wakefullness was gained the participants were asked for nausea and vomiting at recovery room. The outcomes assessor evaluating the participants after the treatment does not know the treatment type made to the patients.
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group Gum
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Abramowitz Emesis Score
Intervention Description
Postoperative vomiting was evaluated by Abramowitz emesis score in recovery room.
Intervention Type
Diagnostic Test
Intervention Name(s)
Degree of nausea
Intervention Description
Degree of postoperative nausea was evaluated.
Intervention Type
Diagnostic Test
Intervention Name(s)
Observer's Assessment of Alertness/Sedation Scale
Intervention Description
Patients' sufficient wakefulness was evaluated by Observer's Assessment of Alertness/Sedation scale in the recovery unit.
Intervention Type
Diagnostic Test
Intervention Name(s)
Patient Satisfaction
Intervention Description
Patient satisfaction was questioned. Answers were recorded as one of the choices (never, sometimes, usually or always)
Intervention Type
Diagnostic Test
Intervention Name(s)
Surgeon Satisfaction
Intervention Description
Surgeon satisfaction was questioned. Answers were recorded as one of the choices (never, sometimes, usually or always)
Intervention Type
Other
Intervention Name(s)
Chewing Peppermint gum
Intervention Description
Peppermint gum was chewed for 15 minutes in patients with sufficient wakefullness.
Primary Outcome Measure Information:
Title
Degree of nausea
Description
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.
Time Frame
24 hours
Title
Emesis
Description
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.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Antiemetic requirement
Description
Antiemetic drugs were given if nausea score was bigger than 3 and Abramowitz emesis scorewas bigger than 1.
Time Frame
24 hours
Title
Patient Satisfaction
Description
Patient satisfaction was questioned. Answers were recorded as one of the choices (0=never, 1=sometimes, 2=usually or 3=always)
Time Frame
24 hours
Title
Surgeon Satisfaction
Description
Surgeon satisfaction was questioned. Answers were recorded as one of the choices (0=never, 1=sometimes, 2=usually or 3=always)
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Canan Yılmaz
Organizational Affiliation
Medical Doctor of Anesthesiology Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bursa Yuksek Ihtisas Education and Research Hospital
City
Bursa
ZIP/Postal Code
16310
Country
Turkey

12. IPD Sharing Statement

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Treatment of Postoperative Nausea-Vomiting in Laparoscopic Cholecystectomy: Peppermint-Flavored Gum Versus Gum-Free

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