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

Phase 1

• Conditions: Postoperative Sore Throat
• Interventions: Other: swallow twice; Drug: chewed mint gum

• Registration Number: NCT03885752
• Lead Sponsor: 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).

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2019-03-17
• Study First Submitted QC: 2019-03-21
• Study First Posted: 2019-03-22
• Study Start: 2019-03-25
• Primary Completion: 2019-05-25
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-06
• Last Update Posted: 2019-06-10
• Study Completion: 2019-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the control group	swallow twice	-
the gum group	chewed mint gum	-

Primary Outcome Measures

Name	Time	Method
the incidence of POST scores > 3	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

Name	Time	Method
the POST scores	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.

Trial Locations

Locations (1)

Ethics Committee of The Obstetrics and Gynecology Hospital, Fudan University,; 🇨🇳 Shanghai, China