Treatment of Postoperative Nausea-Vomiting in Laparoscopic Cholecystectomy: Peppermint-Flavored Gum Versus Gum-Free
Condition: Postoperative Nausea and Vomiting; Chewing Gum
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

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.
    

Intervention name(s): Abramowitz Emesis Score; Degree of nausea; Observer's Assessment of Alertness/Sedation Scale; Patient Satisfaction; Surgeon Satisfaction; Chewing Peppermint gum
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test; Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention 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 (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postoperative Nausea and Vomiting; Chewing gum; Ondansetron