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

November 22, 2020 updated by: Tingting Wang, Fudan University
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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: the Mouthwash group
Patients in the mouthwash group received 15 ml of honeysuckle antibacterial mouthwash and vomited it out after 2 minutes
Other: Mouthwash
Patients in the mouthwash group took 15 ml honeysuckle antibacterial mouthwash in their mouths, and vomited them out after 2 minutes
Active Comparator: the gum group
patients in group gum chewed one piece of herbal sugar-free gum for 2 minutes and then spat it out.
Other: chewed mint gum
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence of POST scores>3
Time Frame: within 24 hours after surgery.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
the POST scores
Time Frame: 2 hours,6 hours and 24 hours after surgery.
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 .
2 hours,6 hours and 24 hours after surgery.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
subgroup analysis with patient subdivided based on whether the laryngeal mask had blood on it.
Time Frame: Immediately after removal of laryngeal mask
blood stain
Immediately after removal of laryngeal mask

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 31, 2020

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

November 22, 2020

First Submitted That Met QC Criteria

November 22, 2020

First Posted (Actual)

November 25, 2020

Study Record Updates

Last Update Posted (Actual)

November 25, 2020

Last Update Submitted That Met QC Criteria

November 22, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Na Chen

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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