Effect of Gargle Containing Honeysuckle and Semen Oroxyli
Status:
Completed
Trial end date:
2022-01-31
Target enrollment:
Participant gender:
Summary
Surgery All patients included in this study underwent UPPP under general anesthesia with a
low-temperature plasma ablation apparatus (PLA-600; Zhongyuan Medical Equipment Co., Ltd.;
Shandong, China). Briefly, the surgery was carried out under general anesthesia using a nasal
cannula. A 70# low-temperature plasma cutter head was used to perform bilateral epicapsular
ablation of the tonsils. Inverted "U" incisions were made on the bilateral soft palate
respectively, and the 70# cutter head progressively melted the adipose tissue and other soft
tissues in the the veli palatine region. Subsequently, a 55# low-temperature plasma cutter
head was used to perform perforation and ablation from between the two mucosal layers of the
soft palate to the direction of the hard palate, with 2-3 holes on each side, and each
ablation time was 8-12 s.
Treatments Patients in both the 2 groups received amoxicillin sodium suspension every 8 hours
for 7 days after UPPP. Except for these drugs, patients in the treatment group were
instructed to gargle the suspension solution containing honeysuckle and semen oroxyli (25 mL)
for 5 minutes. The solution was given 4 times a day for 2 weeks. The patients in the control
group were instructed to gargle normal saline (25 mL) at the same schedule. No NSAIDs were
administered unless requested by the patient.
Data collection The post-operative resting throat pain and swallowing throat pain were
evaluated at 0 week (12 hours after surgery), 1 week and 2 weeks after UPPP by the patients
themselves using a visual analog scale (VAS) based on a linear scale from 0 to 10, where 0
represented an absence of pain and 10 represented maximal pain. Then, the changes of scores
from week 0 to week 2 between the 2 groups were compared. The VAS scores related to patient
comfort level were also evaluated by patients themselves, with 0 representing very much worse
and 10 very much comfort. Furthermore, the researchers who were blinded to the therapeutic
regimens evaluated the improvement in postoperative pain of patients within the 2-week
postoperative period based on the clinical global impression of improvement (CGI-I score)
questionnaire. In this questionnaire, the researchers used a seven-point scale from 1 (very
much improved) to 7 (very much worse) to rate the improvement of body pain of the patients
(10).
The post-operative complications, such as wound infection and wound bleeding, were collected
and analyzed. The baseline characteristics of the patients in 2 groups including age, gender,
body mass index (BMI), OSA severity, American Society of Anesthesiologist (ASA)
classification and pre-operative complications were also collected. The venous blood was
collected at 12 h and 1 week after operation to detect the levels of hs-CRP, hemoglobin,
neutrophil% and white blood cell count (WBC).
Statistical analysis The data in this study were analyzed by the SPSS software (version
22.0). Normal distribution quantitative data were described as mean ± SD. The difference
between groups were compared by the Student's t test. Non-normal distribution quantitative
data were described as median with range and compared with Mann-Whitney U test. Categorical
data were described as numbers and percentages and compared using the Chi-square test or
Fisher's exact test. P < 0.05 was considered as statistical significance.