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NCT Number: NCT04538300

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bursa Yuksek Ihtisas Education and Research Hospital

Bursa, 16310, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Abramowitz Emesis Score

Diagnostic Test

Postoperative vomiting was evaluated by Abramowitz emesis score in recovery room.

Degree of nausea

Diagnostic Test

Degree of postoperative nausea was evaluated.

Observer's Assessment of Alertness/Sedation Scale

Diagnostic Test

Patients' sufficient wakefulness was evaluated by Observer's Assessment of Alertness/Sedation scale in the recovery unit.

Patient Satisfaction

Diagnostic Test

Patient satisfaction was questioned. Answers were recorded as one of the choices (never, sometimes, usually or always)

Surgeon Satisfaction

Diagnostic Test

Surgeon satisfaction was questioned. Answers were recorded as one of the choices (never, sometimes, usually or always)

Chewing Peppermint gum

Other

Peppermint gum was chewed for 15 minutes in patients with sufficient wakefullness.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Antiemetic requirement

    Time frame: 24 hours

    Antiemetic drugs were given if nausea score was bigger than 3 and Abramowitz emesis scorewas bigger than 1.

  2. 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)

  3. 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)

Sponsors and collaborators

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Other Gov

Registry information

Official study title

Effect of Chewing Gum on Treatment of Postoperative Nausea-vomiting in Laparoscopic Cholecystectomy: Prospective, Randomized, Controlled Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 4, 2020
Registry last updated
Sep 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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