Postoperative Sore ThroatNCT07894224
Dexmedetomidine Nasal Spray and Postoperative Sore Throat After Bronchoscopy
An observational study of Postoperative Sore Throat and Bronchoscopy, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Sore Throat, Bronchoscopy, Hoarseness
- What is being tested?
- Dexmedetomidine Nasal Spray and standard general anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 4,400 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexmedetomidine Nasal Spray and Postoperative Sore Throat After Bronchoscopy: A Target Trial Emulation
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.
- Conditions
- Postoperative Sore Throat, Bronchoscopy, Hoarseness, Dysphagia
- Being tested
- Dexmedetomidine Nasal Spray, standard general anesthesia
- Keywords
- Postoperative Sore Throat, Bronchoscopy, General Anesthesia
- Medical subject headings
- Hoarseness, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine Nasal SprayDrug
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 anesthesiaProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Dexmedetomidine group | Adult patients who underwent bronchoscopic procedures under general anesthesia and received dexmedetomidine nasal spray in addition to standard general anesthesia. Receives: Drug: Dexmedetomidine Nasal Spray; Procedure: standard general anesthesia | |
| Control group | Adult patients who underwent bronchoscopic procedures under general anesthesia with standard general anesthesia alone. Receives: Procedure: standard general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Sore Throat on Postoperative Day 1
Measured: Postoperative day 1
Secondary outcomes (7)
Incidence of Postoperative Sore Throat at 1 Hour After Bronchoscopy
Measured: 1 hour after the end of bronchoscopy
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).
Measured: Postoperative day 1
Rate of Postoperative ICU Admission
Measured: Up to 30 days
Rate of Intraoperative Use of Two or More Cardiovascular Active Drugs
Measured: From anesthesia induction to the end of the procedure
Incidence of Intraoperative Cardiovascular Adverse Events
Measured: From anesthesia induction to the end of the procedure
Length of Hospital Stay
Measured: Up to 30 days
Length of Stay in the Post-Anesthesia Care Unit
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start1 Oct 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Sore ThroatStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Tongji Hospital, Tongji University School of Medicine
- Responsible party
- Principal investigator, Wei Wu, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07894224
- Sponsor's protocol ID
- DexFobTTE2026
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Nasal Spray and Postoperative Sore Throat After Bronchoscopy: A Target Trial Emulation
- ClinicalTrials.gov ID
- NCT07894224
- Acronym / sponsor ID
- DexFobTTE2026
- Conditions
- Postoperative Sore Throat, Bronchoscopy, Hoarseness, Dysphagia
- Keywords
- Postoperative Sore Throat, Bronchoscopy, General Anesthesia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,400 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Collaborators
- Shanghai Tongji Hospital, Tongji University School of Medicine
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine group | – | Drug: Dexmedetomidine Nasal Spray, Procedure: standard general anesthesiaAdult patients who underwent bronchoscopic procedures under general anesthesia and received dexmedetomidine nasal spray in addition to standard general anesthesia. |
| Control group | – | Procedure: standard general anesthesiaAdult patients who underwent bronchoscopic procedures under general anesthesia with standard general anesthesia alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine Nasal SprayPreoperative 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. | Drug | Dexmedetomidine group |
| standard general anesthesiaRoutine 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. | Procedure or surgery | Control group, Dexmedetomidine group |
Primary outcome
Incidence of Postoperative Sore Throat on Postoperative Day 1
Time frame: Postoperative day 1
7 secondary outcomes
Incidence of Postoperative Sore Throat at 1 Hour After Bronchoscopy
Time frame: 1 hour after the end of bronchoscopy
Patient Satisfaction Assessed by a 5-point Likert Scale on Postoperative Day 1
Time frame: Postoperative day 1
Rate of Postoperative ICU Admission
Time frame: Up to 30 days
Rate of Intraoperative Use of Two or More Cardiovascular Active Drugs
Time frame: From anesthesia induction to the end of the procedure
Incidence of Intraoperative Cardiovascular Adverse Events
Time frame: From anesthesia induction to the end of the procedure
Length of Hospital Stay
Time frame: Up to 30 days
Length of Stay in the Post-Anesthesia Care Unit
Time frame: Periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Sore Throat and Bronchoscopy, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Sore Throat on Postoperative Day 1 (time frame: Postoperative day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.