Dexmedetomidine Nasal Spray and Postoperative Sore Throat After Bronchoscopy

NCT07894224 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Phase

Observational

Started

2026-10-01

Last updated

2026-10-26

Condition(s) studied

Postoperative Sore ThroatBronchoscopyHoarsenessDysphagia

Investigational drug(s) / intervention(s)

Dexmedetomidine Nasal Spray →standard general anesthesia

Dexmedetomidine Nasal Spray: Preoperative administration of dexmedetomidine nasal spray before anesthesia induction in adult patients undergoing bronchoscopic procedures under general anesthesia.Dose varied according to routine practice. Administered in addition to routine general anesthesia, following routine clinical practice at each center.

standard general anesthesia: Routine general anesthesia for bronchoscopic procedures, administered according to standard clinical practice at each center. Anesthetic agents and airway management followed routine practice and were not assigned by the study.

Study summary

The goal of this observational study is to learn whether dexmedetomidine nasal spray is associated with a lower risk of postoperative sore throat in adult patients who underwent bronchoscopy under general anesthesia. The main questions it aims to answer are:

Is dexmedetomidine nasal spray associated with a lower incidence of sore throat after bronchoscopy? What is the average treatment effect of dexmedetomidine nasal spray on postoperative sore throat? Does the treatment effect differ across patient subgroups (treatment effect heterogeneity)? Researchers will compare patients who received dexmedetomidine nasal spray with patients who did not receive it to see if the nasal spray is associated with less postoperative sore throat, and whether some patients benefit more than others.

This is a two-center retrospective cohort study. No participants will be asked to do anything, and no interventions will be given. Existing medical records of patients who underwent bronchoscopy will be analyzed. The analysis follows a target trial emulation framework, which mimics a randomized trial using existing data, and uses statistical and machine learning methods to account for differences between patient groups.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Age ≥18 years. * Underwent elective bronchoscopic procedures (diagnostic or therapeutic) under general anesthesia. * Airway managed with an endotracheal tube or a supraglottic airway device. * For patients who underwent multiple eligible procedures during the study period, only the first procedure was included. Exclusion Criteria: * Persistent preoperative sore throat, hoarseness, dysphagia, or foreign body sensation in the throat. * Active pharyngeal or laryngeal infection or inflammatory disease, including acute pharyngitis, acute laryngitis, and acute tonsillitis. * Conditions significantly affecting pharyngolaryngeal structure or function, including vocal cord paralysis, laryngeal stenosis, active laryngeal edema, and active tumors involving the pharynx or larynx. * History of pharyngeal, laryngeal, nasal, or paranasal sinus surgery. * Superior vena cava syndrome accompanied by clear upper airway edema, compression, or related pharyngolaryngeal symptoms. * Severe nasal obstruction, active epistaxis, or nasal disease or condition with obvious nasal mucosal injury before surgery. * Pregnancy or lactation. * Known history of allergy to dexmedetomidine or to components of the nasal spray formulation. * High-grade or complete atrioventricular block without an effective pacemaker. * Preoperative marked bradycardia (resting heart rate \<50 beats/min), severe hypotension (systolic blood pressure \<90 mmHg), hemodynamic instability, or severe cardiovascular disease with decompensated heart failure. * Severe hepatic failure, including acute liver failure, acute-on-chronic liver failure, or Child-Pugh class C hepatic dysfunction. * Severe renal failure, including chronic kidney disease stage G5, end-stage renal disease on long-term dialysis, or preoperative KDIGO stage 3 acute kidney injury.

Primary outcome measure(s)

Incidence of Postoperative Sore Throat on Postoperative Day 1 — Postoperative day 1

Trial sites (1)

Facility	City	Region	Status
Shanghai Pulmonary Hospital	Shanghai	Shanghai Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07894224 on ClinicalTrials.gov ↗ ← All trials in China