Back to resultsThe Effects of Preoperatively Chewing Gum on Sore Throat After General Anaesthesia With a Laryngeal Mask
Primary Purpose
Postoperative Sore Throat
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
chewed mint gum
swallow twice
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Sore Throat
Eligibility 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.
-
Sites / Locations
- Ethics Committee of The Obstetrics and Gynecology Hospital, Fudan University,
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
the control group
the gum group
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03885752
Brief Title
The Effects of Preoperatively Chewing Gum on Sore Throat After General Anaesthesia With a Laryngeal Mask
Official Title
The Effects of Preoperatively Chewing Gum on Sore Throat After General Anaesthesia With a Laryngeal Mask
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 25, 2019 (Actual)
Primary Completion Date
May 25, 2019 (Actual)
Study Completion Date
June 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Sore Throat
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
the control group
Arm Type
Active Comparator
Arm Title
the gum group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
chewed mint gum
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
swallow twice
Intervention Description
asked to swallow twice without any additional treatment.
Primary Outcome Measure Information:
Title
the incidence of POST scores > 3
Description
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.
Time Frame
within 24 hours after surgery
Secondary Outcome Measure Information:
Title
the POST scores
Description
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.
Time Frame
2 hours, 6 hours and 24 hours after surgery.
Other Pre-specified Outcome Measures:
Title
subgroup analysis with patient subdivided based on whether the laryngeal mask had blood on it.
Description
blood stain
Time Frame
Immediately after removal of laryngeal mask
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
-
Facility Information:
Facility Name
Ethics Committee of The Obstetrics and Gynecology Hospital, Fudan University,
City
Shanghai
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
31990730
Citation
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.
Results Reference
derived
Learn more about this trial
The Effects of Preoperatively Chewing Gum on Sore Throat After General Anaesthesia With a Laryngeal Mask
We'll reach out to this number within 24 hrs