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The effect of benzydamine hydrochloride on preventing postoperative sore throat after total thyroidectomy: a randomized-controlled trial

  • Doyeon Kim
  • Heejoon Jeong
  • Jihye Kwon
  • Sehee Kang
  • Bobae Han
  • Eun Kyung Lee
  • Sangmin M. Lee
  • Ji Won ChoiEmail author
Reports of Original Investigations

Abstract

Purpose

We compared the effects of benzydamine hydrochloride (BH), 10% lidocaine, and normal saline spray on preventing postoperative sore throat (POST) in patients who underwent total thyroidectomy (TT).

Methods

In this prospective, randomized, parallel-group, double-blind study, the incidence of POST at six hours after tracheal extubation was compared among three groups as a primary outcome. American Society of Anesthesiologists physical status I-II patients undergoing elective TT under general anesthesia were enrolled. Patients were randomly stratified into group C (n = 33, normal saline), group L (n = 33, 10% lidocaine), or group B (n = 33, 0.3% BH). The participants, caregiver, and investigator were blinded to group assignment. Each study drug was sprayed three times on the endotracheal tube (ETT) cuff ten seconds before intubation. Incidence and severity of POST were recorded within 24 hr postoperatively (during postanesthesia care unit stay, and at six, 12, and 24 hr after extubation). P values were adjusted for multiple comparisons.

Results

Ninety-nine patients were enrolled. Eighty-seven patients completed the study. The incidence of POST at six hours after tracheal extubation was similar among the three groups (group C: 31 [93.9%], group L: 29 [87.9%], and group B: 27 [81.8%]; P = 0.38). Nevertheless, the incidence of POST was significantly different among the three groups at 12 and 24 hr after TT (12 hr: P = 0.002, 24 hr: P = 0.01). The severity of POST after tracheal extubation was statistically different among the study groups (6 hr: P = 0.04, 12 hr: P = 0.01). No adverse effects were observed.

Conclusion

Application of BH spray on the ETT cuff reduced the incidence and severity of POST at 12 hr after TT. We suggest this method to be a non-invasive and effective management option for POST without serious side effects.

Trial registration

Clinical Research Information Service (KCT0002627); registered 24 November, 2017.

Effet du chlorhydrate de benzydamine sur la prévention des maux de gorge postopératoires après une thyroïdectomie totale : une étude randomisée contrôlée

Résumé

Objectif

Nous avons comparé les effets de la vaporisation de chlorhydrate de benzydamine (CB), de lidocaïne 10 %, ou de solution saline sur la prévention des maux de gorge postopératoires chez les patients subissant une thyroïdectomie totale (TT).

Méthode

Dans cette étude prospective, randomisée, en parallèle et à double insu, l’incidence des maux de gorge postopératoires six heures après l’extubation trachéale a été comparée dans trois groupes pour répondre à notre critère d’évaluation principal. Des patients de statut physique I-II selon l’American Society of Anesthesiologists et subissant une TT non urgente sous anesthésie générale ont été recrutés. Les patients ont été aléatoirement alloués au groupe C (n = 33, solution saline), au groupe L (n = 33, lidocaïne 10 %), ou au groupe B (n = 33, CB 0,3 %). Les participants, anesthésistes et chercheurs ne connaissaient pas l’allocation de groupe. Chaque médicament étudié était vaporisé trois fois sur le ballonnet du tube endotrachéal (TET) dix secondes avant l’intubation. L’incidence et la gravité des maux de gorge postopératoires ont été enregistrées dans les 24 heures postopératoires (pendant le séjour en salle de réveil, et à six, 12 et 24 h après l’extubation). Les valeurs P ont été ajustées pour tenir compte des comparaisons multiples.

Résultats

Quatre-vingt-dix-neuf patients ont été recrutés. Quatre-vingt-sept patients ont terminé l’étude. L’incidence des maux de gorge postopératoires à six heures après l’extubation trachéale était semblable dans les trois groupes (groupe C : 31 [93,9 %], groupe L : 29 [87,9 %], et groupe B : 27 [81,8 %]; P = 0,38). Toutefois, l’incidence de maux de gorge postopératoires était significativement différente entre les trois groupes à 12 et 24 h après la TT (12 h : P = 0,002, 24 h : P = 0,01). La gravité des maux de gorge postopératoires après l’extubation trachéale était différente d’un point de vue statistique entre les groupes à l’étude (6 h : P = 0,04, 12 h : P = 0,01). Aucun effet secondaire indésirable n’a été observé.

Conclusion

Le recours à une vaporisation de chlorhydrate de benzydamine sur le ballonnet du tube endotrachéal a réduit l’incidence et la gravité des maux de gorge postopératoires à 12 h après une thyroïdectomie totale. Selon nos résultats, cette méthode constitue une option de prise en charge non invasive et efficace des maux de gorge postopératoires sans effets secondaires importants.

Enregistrement de l’étude

Clinical Research Information Service (KCT0002627); enregistrée le 24 novembre 2017.

Notes

Conflicts of interest

None declared.

Editorial responsibility

This submission was handled by Dr. Gregory L. Bryson, Deputy Editor-in-Chief, Canadian Journal of Anesthesia. Dr. Bryson identified the retrospective registration of this trial after accepting the manuscript. He regrets this deviance from Journal policy.

Author contributions

Doyeon Kim participated in design and conduct of the study, data collection, data analysis, and manuscript preparation. Heejoon Jeong contributed to protocol design, data collection, data analysis, and writing the manuscript. Jihye Kwon contributed to the acquisition of data. Sehee Kang and Bobae Han contributed to the analysis of data. Eun Kyung Lee contributed to the interpretation of data. Sangmin M. Lee contributed to the conception and design of the study. Ji Won Choi contributed to all aspects of this study, including conception and design; acquisition, analysis, and interpretation of data, and drafting the article.

Funding

No funding agency in the public, commercial, or not-for-profit sector provided a specific grant for this trial.

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Copyright information

© Canadian Anesthesiologists' Society 2019

Authors and Affiliations

  • Doyeon Kim
    • 1
  • Heejoon Jeong
    • 1
  • Jihye Kwon
    • 1
  • Sehee Kang
    • 1
  • Bobae Han
    • 1
  • Eun Kyung Lee
    • 1
  • Sangmin M. Lee
    • 1
  • Ji Won Choi
    • 1
    Email author
  1. 1.Department of Anesthesiology and Pain Medicine, Samsung Medical CenterSungkyunkwan University School of MedicineSeoulRepublic of Korea

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