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

Postoperative Sore Throat Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03885752
• Other study ID #: TI3WT
• Status: Enrolling by invitation
• Phase: Phase 1/Phase 2
• Start date: March 25, 2019
• Est. completion date: June 30, 2019

Study information

• Verified date: June 2019
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 70
• Est. completion date: June 30, 2019
• Est. primary completion date: May 25, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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.

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Related Conditions & MeSH terms

• Pharyngitis
• Postoperative Sore Throat

Intervention

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.

Other:
• swallow twice
asked to swallow twice without any additional treatment.

Locations

Country	Name	City	State
China	Ethics Committee of The Obstetrics and Gynecology Hospital, Fudan University,	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	subgroup analysis with patient subdivided based on whether the laryngeal mask had blood on it.	blood stain	Immediately after removal of laryngeal mask
Primary	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	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.	2 hours, 6 hours and 24 hours after surgery.