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

Primary Purpose

Postoperative Sore Throat

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
chewed mint gum
Mouthwash
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Sore Throat focused on measuring sore throat, Laryngeal Mask , Chewing Gum , Mouthwash

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

the Mouthwash group

the gum group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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 .

Secondary Outcome Measures

the POST scores
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 .

Full Information

First Posted
November 22, 2020
Last Updated
November 22, 2020
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT04644900
Brief Title
Effect of Chewing Gum and Mouthwash Before Operation on Sore Throat After General Anesthesia With a Laryngeal Mask
Official Title
Effect of Chewing Gum and Mouthwash Before Operation on Sore Throat After General Anesthesia With a Laryngeal Mask
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 31, 2020 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Sore Throat
Keywords
sore throat, Laryngeal Mask , Chewing Gum , Mouthwash

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
the Mouthwash group
Arm Type
Active Comparator
Arm Description
Patients in the mouthwash group received 15 ml of honeysuckle antibacterial mouthwash and vomited it out after 2 minutes
Arm Title
the gum group
Arm Type
Active Comparator
Arm Description
patients in group gum chewed one piece of herbal sugar-free gum for 2 minutes and then spat it out.
Intervention Type
Other
Intervention Name(s)
chewed mint gum
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Mouthwash
Intervention Description
Patients in the mouthwash group took 15 ml honeysuckle antibacterial mouthwash in their mouths, and vomited them out after 2 minutes
Primary Outcome Measure Information:
Title
the incidence of POST scores>3
Description
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 .
Time Frame
within 24 hours after surgery.
Secondary Outcome Measure Information:
Title
the POST scores
Description
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 .
Time Frame
2 hours,6 hours and 24 hours after surgery.
Other Pre-specified Outcome Measures:
Title
subgroup analysis with patient subdivided based on whether the laryngeal mask had blood on it.
Description
blood stain
Time Frame
Immediately after removal of laryngeal mask

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anaesthesiologists(ASA)class I or II 20~65 years body mass index(BMI)scores<30 undergoing elective hysteroscopic surgery Exclusion Criteria: 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.
Facility Information:
Facility Name
Ethics Committee of The Obstetrics and Gynecology Hospital, Fudan University,
City
Shanghai
Country
China

12. IPD Sharing Statement

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

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