Preoperative Chewing Gum and Postoperative Nausea and Vomiting

Study on the Impact of Preoperative Chewing Gum on Postoperative Nausea and Vomiting in Robotic Surgery

General anesthesia for surgery can often lead to postoperative nausea and vomiting (PONV). Additionally, decreased or paralyzed bowel movements are among the most common complications following abdominal surgery, causing pain, abdominal distension, nausea, and vomiting, which can delay patient recovery and extend hospital stays. Therefore, meticulous perioperative management is crucial.

In recent years, efforts have been made to reduce the burden of surgery, decrease postoperative complications, and promote rapid rehabilitation for a quicker return to daily life. These efforts also aim to reduce healthcare costs by shortening hospital stays and optimizing resources. Various interventions, such as early feeding, early removal of nasogastric tubes, and physical therapy, have been trialed in clinical settings to prevent prolonged bowel inactivity and paralysis. However, due to limited clinical efficacy, these methods are not routinely used.

Recently, many researchers have reported the benefits of chewing gum in enhancing bowel motility and reducing PONV. However, there is limited research on the impact of chewing gum on PONV in robotic surgeries, which are considered less invasive compared to open or laparoscopic surgeries. Furthermore, there is particularly scarce research on the effects of preoperative gum chewing.

Study Overview

• Status: Not yet recruiting
• Conditions: Gynecologic Disease
• Intervention / Treatment: Other: Chewing sugar-free gum

• Study Type: Interventional
• Enrollment (Estimated): 92
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Min Suk Chae, MD, PhD; Phone Number: 0222586150; Email: shscms@catholic.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult patients aged 19 to under 70 years
2. Scheduled elective robotic surgery
3. American Society of Anesthesiologists (ASA) Physical Status Classification I or II

Exclusion Criteria:

1. Cases where robotic surgery was planned but suddenly converted to another type of surgery
2. Patients with a history of dental damage, dentures, loose or capped teeth, or other unstable dental conditions
3. Patients with a history of temporomandibular joint (TMJ) damage or surgery
4. Head and neck surgeries
5. Emergency surgeries
6. Refusal to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Preoperative chewing gum group; Upon arrival at the preoperative preparation room, patients begin chewing sugar-free gum provided by the preoperative nurse. They continue chewing until they enter the operating room (for at least 15 minutes). Before entering the operating room, it is confirmed that the gum has been discarded.	Other: Chewing sugar-free gum; Upon arrival at the preoperative preparation room, patients begin chewing sugar-free gum provided by the preoperative nurse. They continue chewing until they enter the operating room (for at least 15 minutes). Before entering the operating room, it is confirmed that the gum has been discarded.
No Intervention: No preoperative chewing gum group; After arriving at the preoperative preparation room, patients wait without chewing gum until they enter the operating room.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
nausea and vomiting	Incidence of nausea and vomiting in the post-anesthesia care unit	One hour after surgery, referring to the period spent in the post-anesthesia care unit

Collaborators and Investigators

• Sponsor: Min Suk Chae

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 31, 2024
• First Submitted That Met QC Criteria: May 31, 2024
• First Posted (Actual): June 6, 2024

Study Record Updates

• Last Update Posted (Actual): June 6, 2024
• Last Update Submitted That Met QC Criteria: May 31, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Vomiting; Postoperative Nausea and Vomiting; Genital Diseases, Female
• Other Study ID Numbers: KC24EISI0138

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No