Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03885752
Recruitment Status : Enrolling by invitation
First Posted : March 22, 2019
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
Tingting Wang, Fudan University

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Postoperative Sore Throat Drug: chewed mint gum Other: swallow twice Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects of Preoperatively Chewing Gum on Sore Throat After General Anaesthesia With a Laryngeal Mask
Actual Study Start Date : March 25, 2019
Actual Primary Completion Date : May 25, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sore Throat

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885752


Locations
Layout table for location information
China
Ethics Committee of The Obstetrics and Gynecology Hospital, Fudan University,
Shanghai, China
Sponsors and Collaborators
Fudan University
Layout table for additonal information
Responsible Party: Tingting Wang, Director, Principal Investigator, Clinical Professor, Fudan University
ClinicalTrials.gov Identifier: NCT03885752    
Other Study ID Numbers: TI3WT
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: June 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases