Preoperative Chewing Gum and Postoperative Nausea and Vomiting

NCT ID: NCT06446583

Last Updated: 2024-06-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2024-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Chewing sugar-free gum

Intervention Type: 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.

No preoperative chewing gum group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Min Suk Chae

OTHER

Sponsor Role: lead

Responsible Party

Min Suk Chae

Associate professor. CHAE, Min Suk

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Min Suk Chae, MD, PhD

Role: CONTACT

shscms@catholic.ac.kr

0222586150

Other Identifiers

KC24EISI0138

Identifier Type: -

Identifier Source: org_study_id