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

NCT04538300 | Completed

• 1 other identifier: 2017-5/35
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Nausea and Vomiting; Chewing Gum

Keywords

Postoperative Nausea and Vomiting; Chewing gum; Ondansetron

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Antiemetic requirement

  24 hours

• Patient Satisfaction

  24 hours

• Surgeon Satisfaction

  24 hours

Study Arms (2)

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.

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.

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

Interventions

Abramowitz Emesis Score DIAGNOSTIC_TEST

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

Group Control; Group Gum

Degree of nausea DIAGNOSTIC_TEST

Degree of postoperative nausea was evaluated.

Group Control; Group Gum

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.

Group Control; Group Gum

Patient Satisfaction DIAGNOSTIC_TEST

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

Group Control; Group Gum

Surgeon Satisfaction DIAGNOSTIC_TEST

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

Group Control; Group Gum

Chewing Peppermint gum OTHER

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

Group Gum

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• undergone for elective laparoscopic cholecystectomy under general anaesthesia
• American Society of Anesthesiologist (ASA) I-II
• Patients between the ages of 18-65

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

Bursa Yuksek Ihtisas Education and Research Hospital

Bursa, 16310, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Officials

• Canan Yılmaz

  Medical Doctor of Anesthesiology Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 4, 2020
• Study Start: May 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: May 3, 2018
• Last Updated: September 7, 2020

Record last verified: 2020-09

Locations

TU (1)