Randomized controlled trial to examine the tolerability of bronchoscopy with and without pharyngeal laryngeal anesthesia (TACOYAKI study).

Background: The SARS-CoV-2 pandemic, pharyngeal anesthesia such as nebulizer or lidocaine pump spray is the risk of droplet transmission to health care workers from coughing due to spraying anesthesia. Absence of pharyngeal anesthesia may induce coughing and reduce patient and operator satisfaction, but the efficacy of pharyngeal anesthesia under sedation is still limited. Therefore we evaluated a prospective, randomized, single-blind trial to evaluate efficacy of pharyngeal anesthesia in patients receiving sedation.

Materials And Methods: We conducted a randomized comparison of pharyngeal anesthesia with or without bronchoalveolar lavage in patients undergoing bronchoscopy at our hospital between March and October 2022. Pharyngeal anesthesia was performed using 8％ lidocaine spray and the operators were blinded to eliminate bias. Two hundred patients were entered into the study and divided into two groups: those who received pharyngeal anesthesia(control group) and did not receive pharyngeal anesthesia(test group). The primary endpoint was the operator's satisfaction with the procedure. The secondary endpoints were the patient's cough during the examination as perceived by the operator, cough and discomfort experienced by the patient and the dose of analgesic/sedative/lidocaine administered. These scales were scored from 0 to 100.

Result: In primary endpoint, there was no significant difference in the operator-rated procedure satisfaction between the 2 groups. The median for the discomfort score for patients in the control group was tendency higher than in the test group. There were no significant differences in other secondary endpoints.

Conclusion: Pharyngeal anesthesia may not be recommended for flexible bronchoscopy performed under combined sedation and analgesia.

Trial Registration: Registration number: UMIN000046975Date of registration: 2022/03/07.