The Effects of Preoperatively Chewing Gum on Sore Throat After General Anaesthesia With a Laryngeal Mask
1 other identifier
interventional
70
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2019
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2019
CompletedFirst Posted
Study publicly available on registry
March 22, 2019
CompletedStudy Start
First participant enrolled
March 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2019
CompletedJune 10, 2019
June 1, 2019
2 months
March 17, 2019
June 6, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
the POST scores
2 hours, 6 hours and 24 hours after surgery.
Other Outcomes (1)
subgroup analysis with patient subdivided based on whether the laryngeal mask had blood on it.
Immediately after removal of laryngeal mask
Study Arms (2)
the control group
ACTIVE COMPARATORthe gum group
PLACEBO COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- American Society of Anaesthesiologists (ASA) class I or II 20-65 years body mass index (BMI) scores \<30 undergoing elective hysteroscopic surgery -
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Ethics Committee of The Obstetrics and Gynecology Hospital, Fudan University,
Shanghai, China
Related Publications (1)
Wang T, Wang Q, Zhou H, Huang S. Effects of Preoperative Gum Chewing on Sore Throat After General Anesthesia With a Supraglottic Airway Device: A Randomized Controlled Trial. Anesth Analg. 2020 Dec;131(6):1864-1871. doi: 10.1213/ANE.0000000000004664.
PMID: 31990730DERIVED
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Principal Investigator, Clinical Professor
Study Record Dates
First Submitted
March 17, 2019
First Posted
March 22, 2019
Study Start
March 25, 2019
Primary Completion
May 25, 2019
Study Completion
June 30, 2019
Last Updated
June 10, 2019
Record last verified: 2019-06