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Active, not recruitingNCT07894224Updated Oct 26, 2026

Dexmedetomidine Nasal Spray and Postoperative Sore Throat After Bronchoscopy

An observational study in Postoperative Sore Throat, Bronchoscopy and Hoarseness, sponsored by Shanghai Pulmonary Hospital, Shanghai, China. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by Shanghai Pulmonary Hospital, Shanghai, China · Observational

Updated Oct 26, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
4,400
Ages
18 Years and older
Sex
All
01

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.

Read the detailed description

Background and Objectives Postoperative sore throat after bronchoscopy, including throat pain, hoarseness, foreign body sensation, and dysphagia, is a common adverse event following bronchoscopic procedures performed under general anesthesia. It impairs patient comfort and delays postoperative recovery. Dexmedetomidine nasal spray is used perioperatively for sedation and anxiolysis, but evidence on its relationship with postoperative sore throat in routine clinical practice remains limited. Using real-world data within a target trial emulation (TTE) framework, this study investigates the association between dexmedetomidine nasal spray and postoperative sore throat after bronchoscopy, estimates its treatment effect, and explores heterogeneity of treatment effect (HTE).

Study Design This is a two-center retrospective cohort study of adult patients who underwent bronchoscopic procedures under general anesthesia. The study follows the TTE framework: a hypothetical target trial protocol was first specified and then emulated using observational data.

Statistical Analysis Plan Propensity scores will be estimated from baseline covariates, and overlap weighting will be used to estimate the average treatment effect in the overlap population . Heterogeneity of treatment effect will be explored using the R-learner, a machine learning-based meta-learner, to estimate conditional average treatment effects (CATE). Missing data and unmeasured confounding will be addressed through sensitivity analyses.

02

Conditions studied

  • Postoperative Sore Throat
  • Bronchoscopy
  • Hoarseness
  • Dysphagia

Keywords

  • Postoperative Sore Throat
  • Bronchoscopy
  • General Anesthesia
03

In context

Hoarseness

52 studies on the registry are indexed under Hoarseness; 9 are open to participants now.

Browse Hoarseness studies →

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China is the lead sponsor of 160 studies on the registry; 95 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients (aged ≥18 years) who underwent elective bronchoscopic procedures (diagnostic or therapeutic) under general anesthesia, with airway managed by an endotracheal tube or supraglottic airway device, at two tertiary hospitals between January 1, 2023 and December 31, 2025. Patients were identified from the hospitals' electronic medical records and anesthesia information systems. Those who received preoperative dexmedetomidine nasal spray were compared with those who did not. For patients with multiple eligible procedures, only the first procedure was included.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
4,400 participants (estimated)
Patient registry
No

Groups and cohorts

  • Dexmedetomidine group

    Adult patients who underwent bronchoscopic procedures under general anesthesia and received dexmedetomidine nasal spray in addition to standard general anesthesia.

    Drug: Dexmedetomidine Nasal Spray · Procedure: standard general anesthesia

  • Control group

    Adult patients who underwent bronchoscopic procedures under general anesthesia with standard general anesthesia alone.

    Procedure: standard general anesthesia

Interventions

  • 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.

  • Procedurestandard 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.

06

What researchers measure

Primary outcomes

  1. Incidence of Postoperative Sore Throat on Postoperative Day 1

    Time frame: Postoperative day 1

Secondary outcomes

  1. Incidence of Postoperative Sore Throat at 1 Hour After Bronchoscopy

    Time frame: 1 hour after the end of bronchoscopy

  2. Patient Satisfaction Assessed by a 5-point Likert Scale on Postoperative Day 1

    Patient satisfaction with perioperative care were assessed using a 5-point Likert scale (1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, 5 = very satisfied).

    Time frame: Postoperative day 1

  3. Rate of Postoperative ICU Admission

    Time frame: Up to 30 days

  4. Rate of Intraoperative Use of Two or More Cardiovascular Active Drugs

    Time frame: From anesthesia induction to the end of the procedure

  5. Incidence of Intraoperative Cardiovascular Adverse Events

    Time frame: From anesthesia induction to the end of the procedure

  6. Length of Hospital Stay

    Time frame: Up to 30 days

  7. Length of Stay in the Post-Anesthesia Care Unit

    Time frame: Periprocedural

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared because the data were obtained from the electronic medical records of two hospitals, and the ethics approval does not cover data sharing with third parties. Aggregated results and statistical analysis code may be made available from the corresponding author upon reasonable request.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2026 (actual). Primary completion is estimated for Dec 2026, 2 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 18, 2026
First posted
Oct 26, 2026
StartActual
Oct 1, 2026
Primary completionEst.
Dec 1, 2026
CompletionEst.
Dec 31, 2026
Last update
Oct 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07894224
Collaborators
Shanghai Tongji Hospital, Tongji University School of Medicine
Responsible party
Wei Wu (Attending Physician, Shanghai Pulmonary Hospital, Shanghai, China) — Principal investigator
First posted
Oct 26, 2026
Start date
Oct 1, 2026
Primary completion
Dec 1, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Oct 26, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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