Preoperative Chewing Gum and Postoperative Nausea and Vomiting

NCT06446583 | Not Yet Recruiting

• 1 other identifier: KC24EISI0138
• Study Type: interventional
• Target: 92
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Gynecologic Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Preoperative chewing gum group

EXPERIMENTAL

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

No preoperative chewing gum group

NO INTERVENTION

After arriving at the preoperative preparation room, patients wait without chewing gum until they enter the operating room.

Interventions

Chewing sugar-free gum OTHER

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.

Preoperative chewing gum group

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Min Suk Chae: lead

MeSH Terms

Conditions

Genital Diseases, Female

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Min Suk Chae, MD, PhD

CONTACT

0222586150; shscms@catholic.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor. CHAE, Min Suk

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 6, 2024
• Study Start: June 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share