The Effects of Preoperatively Chewing Gum on Sore Throat After General Anaesthesia With a Laryngeal Mask

June 6, 2019 updated by: Tingting Wang, Fudan University
Postoperative sore throat (POST) is an important problem after general anaesthesia. We assessed whether chewing gum preoperatively 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

  • Phase 2
  • Phase 1

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

20 years to 65 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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: the control group
Other: swallow twice
asked to swallow twice without any additional treatment.
Placebo Comparator: the gum group
Drug: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

March 25, 2019

Primary Completion (Actual)

May 25, 2019

Study Completion (Anticipated)

June 30, 2019

Study Registration Dates

First Submitted

March 17, 2019

First Submitted That Met QC Criteria

March 21, 2019

First Posted (Actual)

March 22, 2019

Study Record Updates

Last Update Posted (Actual)

June 10, 2019

Last Update Submitted That Met QC Criteria

June 6, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TI3WT

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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