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

Postoperative Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04538300
• Other study ID #: 2017-5/35
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: May 3, 2018

Study information

• Verified date: September 2020
• Source: Bursa Yüksek Ihtisas Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 3, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chewing Gum
• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Diagnostic Test:
• Abramowitz Emesis Score
Postoperative vomiting was evaluated by Abramowitz emesis score in recovery room.
• Degree of nausea
Degree of postoperative nausea was evaluated.
• Observer's Assessment of Alertness/Sedation Scale
Patients' sufficient wakefulness was evaluated by Observer's Assessment of Alertness/Sedation scale in the recovery unit.
• Patient Satisfaction
Patient satisfaction was questioned. Answers were recorded as one of the choices (never, sometimes, usually or always)
• Surgeon Satisfaction
Surgeon satisfaction was questioned. Answers were recorded as one of the choices (never, sometimes, usually or always)

Other:
• Chewing Peppermint gum
Peppermint gum was chewed for 15 minutes in patients with sufficient wakefullness.

Locations

Country	Name	City	State
Turkey	Bursa Yuksek Ihtisas Education and Research Hospital	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Bursa Yüksek Ihtisas Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 hours
Primary	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.	24 hours
Secondary	Antiemetic requirement	Antiemetic drugs were given if nausea score was bigger than 3 and Abramowitz emesis scorewas bigger than 1.	24 hours
Secondary	Patient Satisfaction	Patient satisfaction was questioned. Answers were recorded as one of the choices (0=never, 1=sometimes, 2=usually or 3=always)	24 hours
Secondary	Surgeon Satisfaction	Surgeon satisfaction was questioned. Answers were recorded as one of the choices (0=never, 1=sometimes, 2=usually or 3=always)	24 hours