The Effects of Preoperatively Chewing Gum on Sore Throat After General Anaesthesia With a Laryngeal Mask
|ClinicalTrials.gov Identifier: NCT03885752|
Recruitment Status : Enrolling by invitation
First Posted : March 22, 2019
Last Update Posted : June 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Sore Throat||Drug: chewed mint gum Other: swallow twice||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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|
|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.
- 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.
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885752
|Ethics Committee of The Obstetrics and Gynecology Hospital, Fudan University,|