Effect of Chewing Gum and Mouthwash Before Operation on Sore Throat After General Anesthesia With a Laryngeal Mask

NCT04644900 | Unknown

• 1 other identifier: Na Chen
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative sore throat (POST) is an important problem after general anaesthesia. We assessed whether chewing gum preoperatively or mouthwash can reduce the incidence of POST after general anaesthesia administered via a streamlined liner of the pharyngeal airway (SLIPA).

Conditions

Postoperative Sore Throat

Keywords

sore throat, Laryngeal Mask , Chewing Gum , Mouthwash

Outcome Measures

Primary Outcomes (1)

• the incidence of POST scores>3

  POST was evaluated by the Numerical Rating Scale(NRS),which ranges from 0 to 10 points,with 0 indicating completely painless,1\~3 indicating mild discomfort,4\~6 indicating moderate pain,and 7\~10 indicating severe pain .

  within 24 hours after surgery.

Secondary Outcomes (1)

• the POST scores

  2 hours,6 hours and 24 hours after surgery.

Other Outcomes (1)

• subgroup analysis with patient subdivided based on whether the laryngeal mask had blood on it.

  Immediately after removal of laryngeal mask

Study Arms (2)

the Mouthwash group

ACTIVE COMPARATOR

Patients in the mouthwash group received 15 ml of honeysuckle antibacterial mouthwash and vomited it out after 2 minutes

Other: Mouthwash

the gum group

ACTIVE COMPARATOR

patients in group gum chewed one piece of herbal sugar-free gum for 2 minutes and then spat it out.

Other: chewed mint gum

Interventions

chewed mint gum OTHER

In the preoperative waiting area before transferring to the operating room,patients in group G chewed mint gum for 2 minutes and then spit it out.

the gum group

Mouthwash OTHER

Patients in the mouthwash group took 15 ml honeysuckle antibacterial mouthwash in their mouths, and vomited them out after 2 minutes

the Mouthwash group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anaesthesiologists(ASA)class I or II 20\~65 years body mass index(BMI)scores\<30 undergoing elective hysteroscopic surgery

You may not qualify if:

• chronic laryngitis chronic bronchitis asthma gastroesophageal reflux allergies to study drugs recent use of non-steroidal anti-inflammatory drugs(NSAIDS) a history of upper respiratory tract infection in the past one week Mallampati grade\>2 a history of steroid therapy.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Ethics Committee of The Obstetrics and Gynecology Hospital, Fudan University,

Shanghai, China

Location

MeSH Terms

Conditions

Pharyngitis

Interventions

Mouthwashes

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: November 22, 2020
• First Posted: November 25, 2020
• Study Start: December 31, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: November 25, 2020

Record last verified: 2020-11

Locations

CN (1)