HoarsenessNCT07722091
Intraperitoneal Dexamethasone Spraying on Vagal Nerve-Rich Areas for Prevention of Hoarseness After Upper Abdominal Surgery
A study testing Dexamethasone and Saline (0.9% NaCl) in people with Hoarseness and Post Operative Complicaiton, run by Fujian Medical University Union Hospital at 4 sites in China.
Trial summary
The goal of this clinical trial is to evaluate whether intraoperative spraying of dexamethasone onto the abdominal vagal nerve-rich areas can prevent postoperative hoarseness in patients undergoing elective upper abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hoarseness, Post Operative Complicaiton
- What is being tested?
- Dexamethasone and Saline (0.9% NaCl)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 584 participants
- Where
- 4 sitesChina
- Study dates
- 27 Jul 2026to 1 Mar 2027
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years, both sexes.
- Elective abdominal surgery (including gastric, hepatobiliary, and pancreaticoduodenal surgery) under general anesthesia.
- American Society of Anesthesiologists (ASA) physical status classification I-III.
- Preoperative GRBAS Grade (G) score = 0 (no hoarseness).
- Signed written informed consent.
Who cannot join
- Need for systemic glucocorticoid therapy during hospitalization for other reasons.
- Pre-existing hoarseness, vocal cord paralysis, or organic vocal cord lesions.
- History of neck surgery, neck radiotherapy, or laryngeal surgery.
- Known allergy to dexamethasone or other glucocorticoids.
- Active peptic ulcer or gastrointestinal bleeding within 6 months prior to enrollment.
- Uncontrolled diabetes mellitus or severe active infection.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian
Shi, +86-18259992395, shikg2001@163.com
- Not yet recruiting
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian
Yan, +86-18850377157, mcgdyyll@126.com
- Not yet recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Min, +86-0791-88692748, candymin66@163.com
- Not yet recruiting
The Second Affiliated Hospital of Fujian Medical University
Quanzhou, Fujian
He, +86-15905921859, 15905921859@163.com
About this study
Official title: Intraperitoneal Dexamethasone Spraying on Vagal Nerve-Rich Areas for Prevention of Hoarseness After Upper Abdominal Surgery: A Prospective Randomized Controlled Trial
The goal of this clinical trial is to evaluate whether intraoperative spraying of dexamethasone onto the abdominal vagal nerve-rich areas can prevent postoperative hoarseness in patients undergoing elective upper abdominal surgery. The main questions it aims to answer are:
- Does intraoperative topical dexamethasone spraying reduce the incidence of postoperative hoarseness after upper abdominal surgery?
- Does postoperative intravenous dexamethasone accelerate recovery in patients who develop hoarseness? Researchers will compare a dexamethasone group (intraoperative spraying of 10 mg dexamethasone in 10 mL normal saline) to a placebo group (intraoperative spraying of 10 mL normal saline alone) to see if dexamethasone reduces the rate of postoperative hoarseness.
Read more
Participants will:
- Undergo voice assessment (GRBAS scale) and voice recording before surgery and daily for 10 days after surgery.
- Be randomly assigned to receive either dexamethasone or placebo sprayed onto the surgical field at the end of the operation.
- If hoarseness develops in the placebo group, be randomly assigned again to receive either intravenous dexamethasone (5 mg daily for 3 days) or placebo.
Read the detailed description
The mechanism of postoperative hoarseness remains unclear. It is traditionally attributed to direct injury to the recurrent laryngeal nerve or to endotracheal intubation. However, the surgical field in upper abdominal procedures is remote from the recurrent laryngeal nerve, yet the incidence of hoarseness is higher than in many other surgeries. Preclinical animal experiments by the research group have demonstrated that electrical or thermal stimulation of the subdiaphragmatic vagal nerve can induce vocal cord paralysis, and that immediate topical spraying of dexamethasone onto the affected area significantly reduces this effect. It is hypothesized that thermal injury to vagal nerve fibers in the upper abdomen triggers aberrant signaling through the solitary nucleus to the nucleus ambiguus, ultimately resulting in dysfunction of the recurrent laryngeal nerve.
This trial is designed as a multi-center, prospective, randomized, double-blind, placebo-controlled study. A total of 584 adult patients scheduled for elective gastric, hepatobiliary, or pancreaticoduodenal surgery will be enrolled. At the end of the main surgical procedure and before abdominal closure, the surgeon will spray 10 mg of dexamethasone onto the vagal nerve-rich areas, such as the peritoneum around the esophageal hiatus, the lesser omental sac, and the surface of the hepatoduodenal ligament.
Voice assessments will be conducted daily from postoperative day 1 through day 10 using the GRBAS scale by a trained evaluator blinded to group assignment. Patients will also undergo voice acoustic recording for Praat analysis. Those in the placebo group who develop hoarseness will be re-randomized to receive either intravenous dexamethasone 5 mg or placebo daily for 3 days.
- Conditions
- Hoarseness, Post Operative Complicaiton
- Being tested
- Dexamethasone, Saline (0.9% NaCl)
- Keywords
- Dexamethasone, Postoperative Hoarseness, Upper Abdominal Surgery
- Medical subject headings
- Hoarseness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Dexamethasone 10 mg diluted in 10 mL normal saline, sprayed topically onto the vagal nerve-rich areas (esophageal hiatus, lesser omental sac, hepatoduodenal ligament) once at the end of surgery before abdominal closure.
Saline (0.9% NaCl)Drug
10 mL normal saline sprayed topically onto the same vagal nerve-rich areas once at the end of surgery before abdominal closure. Patients in the placebo group who develop hoarseness (GRBAS Grade ≥ 2) will be re-randomized to receive intravenous dexamethasone 5 mg daily or placebo for 3 days.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone Prophylaxis Group | Experimental | At the end of surgery before abdominal closure, 10 mg dexamethasone diluted in 10 mL normal saline is sprayed onto the vagal nerve-rich areas: peritoneum around the esophageal hiatus, lesser omental sac, and surface of the hepatoduodenal ligament. Voice assessed daily (GRBAS scale + Praat recording) from postoperative day 1-10. Receives: Drug: Dexamethasone |
| Placebo Control Group | Placebo comparator | At the end of surgery before abdominal closure, 10 mL normal saline alone is sprayed onto the same vagal nerve-rich areas. Voice assessed daily (GRBAS scale + Praat recording) from postoperative day 1-10. Patients who develop hoarseness (GRBAS Grade ≥2) are re-randomized to receive intravenous dexamethasone 5 mg or placebo daily for 3 days. Receives: Drug: Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative hoarseness within 10 days
The proportion of patients with a GRBAS (Grade, Roughness, Breathiness, Asthenia, Strain) Grade (G) score ≥ 2 at any time point from postoperative day 1 to day 10.
Measured: Postoperative day 1 to day 10.
Secondary outcomes (3)
Time to recovery from hoarseness
Measured: From first diagnosis of hoarseness (GRBAS G ≥2) to recovery of voice (GRBAS G <2), assessed up to postoperative day 10.
Change in objective voice acoustic parameters measured by Praat software
Voice samples are recorded using the same professional recording device with the participant producing a sustained vowel /a:/ for at least 5 seconds (sampling rate 44.1 kHz or 48 kHz, mono, WAV format). The recorded samples are analyzed using Praat software (University of Amsterdam) to extract the following parameters: Jitter (local, %), Fundamental Frequency (F0, Hz), and Harmonics-to-Noise Ratio (HNR, dB). The change in each parameter from baseline will be reported for each group.
Measured: Postoperative day 1 to day 10.
Change in Grade, Roughness, Breathiness, Asthenia, and Strain (GRBAS) scale subscores over time
The GRBAS (Grade, Roughness, Breathiness, Asthenia, Strain) scale is a perceptual voice assessment tool. For this study, only the Grade (G) subscore is measured. The G subscore assesses overall hoarseness severity on a 0-3 scale (0=normal, 1=mild, 2=moderate, 3=severe), with higher scores indicating worse voice quality. The G subscore is assessed daily from postoperative day 1 through day 10 and compared between groups to evaluate the trajectory of voice changes. The other four dimensions (R, B, A, S) are not formally scored in this study.
Measured: Postoperative day 1 to day 10.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start27 Jul 2026
- Primary completion30 Jan 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HoarsenessStudies of the same condition, open and under way.
- More trials run by Fujian Medical University Union HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 584 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Affiliated Hospital of Fujian Medical University, Meng Chao Hepatobiliary Hospital of Fujian Medical University, The First Affiliated Hospital of Nanchang University
- Responsible party
- Principal investigator, shikaige, Fujian Medical University Union Hospital
- Investigators
- ZHONGMENG LAI, Principal investigator, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722091
- Sponsor's protocol ID
- 2026KY683-02
- Status last verified
- Sep 2026
- First submitted
- 11 Jul 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraperitoneal Dexamethasone Spraying on Vagal Nerve-Rich Areas for Prevention of Hoarseness After Upper Abdominal Surgery: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07722091
- Acronym / sponsor ID
- 2026KY683-02
- Conditions
- Hoarseness, Post Operative Complicaiton
- Keywords
- Dexamethasone, Postoperative Hoarseness, Upper Abdominal Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 584 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Collaborators
- The Second Affiliated Hospital of Fujian Medical University, Meng Chao Hepatobiliary Hospital of Fujian Medical University, The First Affiliated Hospital of Nanchang University
- Study start
- 27 Jul 2026 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 23 Jul 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 clinical trial is to evaluate whether intraoperative spraying of dexamethasone onto the abdominal vagal nerve-rich areas can prevent postoperative hoarseness in patients undergoing elective upper abdominal surgery. The main questions it aims to answer are:
- Does intraoperative topical dexamethasone spraying reduce the incidence of postoperative hoarseness after upper abdominal surgery?
- Does postoperative intravenous dexamethasone accelerate recovery in patients who develop hoarseness? Researchers will compare a dexamethasone group (intraoperative spraying of 10 mg dexamethasone in 10 mL normal saline) to a placebo group (intraoperative spraying of 10 mL normal saline alone) to see if dexamethasone reduces the rate of postoperative hoarseness.
Participants will:
- Undergo voice assessment (GRBAS scale) and voice recording before surgery and daily for 10 days after surgery.
- Be randomly assigned to receive either dexamethasone or placebo sprayed onto the surgical field at the end of the operation.
- If hoarseness develops in the placebo group, be randomly assigned again to receive either intravenous dexamethasone (5 mg daily for 3 days) or placebo.
Detailed description
The mechanism of postoperative hoarseness remains unclear. It is traditionally attributed to direct injury to the recurrent laryngeal nerve or to endotracheal intubation. However, the surgical field in upper abdominal procedures is remote from the recurrent laryngeal nerve, yet the incidence of hoarseness is higher than in many other surgeries. Preclinical animal experiments by the research group have demonstrated that electrical or thermal stimulation of the subdiaphragmatic vagal nerve can induce vocal cord paralysis, and that immediate topical spraying of dexamethasone onto the affected area significantly reduces this effect. It is hypothesized that thermal injury to vagal nerve fibers in the upper abdomen triggers aberrant signaling through the solitary nucleus to the nucleus ambiguus, ultimately resulting in dysfunction of the recurrent laryngeal nerve.
This trial is designed as a multi-center, prospective, randomized, double-blind, placebo-controlled study. A total of 584 adult patients scheduled for elective gastric, hepatobiliary, or pancreaticoduodenal surgery will be enrolled. At the end of the main surgical procedure and before abdominal closure, the surgeon will spray 10 mg of dexamethasone onto the vagal nerve-rich areas, such as the peritoneum around the esophageal hiatus, the lesser omental sac, and the surface of the hepatoduodenal ligament.
Voice assessments will be conducted daily from postoperative day 1 through day 10 using the GRBAS scale by a trained evaluator blinded to group assignment. Patients will also undergo voice acoustic recording for Praat analysis. Those in the placebo group who develop hoarseness will be re-randomized to receive either intravenous dexamethasone 5 mg or placebo daily for 3 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone Prophylaxis Group | Experimental | Drug: DexamethasoneAt the end of surgery before abdominal closure, 10 mg dexamethasone diluted in 10 mL normal saline is sprayed onto the vagal nerve-rich areas: peritoneum around the esophageal hiatus, lesser omental sac, and surface of the hepatoduodenal ligament. Voice assessed daily (GRBAS scale + Praat recording) from postoperative day 1-10. |
| Placebo Control Group | Placebo comparator | Drug: Saline (0.9% NaCl)At the end of surgery before abdominal closure, 10 mL normal saline alone is sprayed onto the same vagal nerve-rich areas. Voice assessed daily (GRBAS scale + Praat recording) from postoperative day 1-10. Patients who develop hoarseness (GRBAS Grade ≥2) are re-randomized to receive intravenous dexamethasone 5 mg or placebo daily for 3 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 to 75 years, both sexes.
- Elective abdominal surgery (including gastric, hepatobiliary, and pancreaticoduodenal surgery) under general anesthesia.
- American Society of Anesthesiologists (ASA) physical status classification I-III.
- Preoperative GRBAS Grade (G) score = 0 (no hoarseness).
- Signed written informed consent.
Key exclusion criteria (6 listed)
- Need for systemic glucocorticoid therapy during hospitalization for other reasons.
- Pre-existing hoarseness, vocal cord paralysis, or organic vocal cord lesions.
- History of neck surgery, neck radiotherapy, or laryngeal surgery.
- Known allergy to dexamethasone or other glucocorticoids.
- Active peptic ulcer or gastrointestinal bleeding within 6 months prior to enrollment.
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 |
|---|---|---|
| DexamethasoneDexamethasone 10 mg diluted in 10 mL normal saline, sprayed topically onto the vagal nerve-rich areas (esophageal hiatus, lesser omental sac, hepatoduodenal ligament) once at the end of surgery before abdominal closure. | Drug | Dexamethasone Prophylaxis Group |
| Saline (0.9% NaCl)10 mL normal saline sprayed topically onto the same vagal nerve-rich areas once at the end of surgery before abdominal closure. Patients in the placebo group who develop hoarseness (GRBAS Grade ≥ 2) will be re-randomized to receive intravenous dexamethasone 5 mg daily or placebo for 3 days. | Drug | Placebo Control Group |
Primary outcome
Incidence of postoperative hoarseness within 10 days
Time frame: Postoperative day 1 to day 10.
The proportion of patients with a GRBAS (Grade, Roughness, Breathiness, Asthenia, Strain) Grade (G) score ≥ 2 at any time point from postoperative day 1 to day 10.
3 secondary outcomes
Time to recovery from hoarseness
Time frame: From first diagnosis of hoarseness (GRBAS G ≥2) to recovery of voice (GRBAS G <2), assessed up to postoperative day 10.
Change in objective voice acoustic parameters measured by Praat software
Time frame: Postoperative day 1 to day 10.
Change in Grade, Roughness, Breathiness, Asthenia, and Strain (GRBAS) scale subscores over time
Time frame: Postoperative day 1 to day 10.
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 23 Sep 2026.
- Individual participant dataSharing planned: No
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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.
ZHONGMENG LAI principal investigator
Fujian Medical University Union Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone and Saline (0.9% NaCl) in people with Hoarseness and Post Operative Complicaiton, run by Fujian Medical University Union Hospital at 4 sites 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. Some participants in this study may receive a placebo. 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?
Contact KAIGE SHI (+86-18259992395, shikg2001@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative hoarseness within 10 days (time frame: Postoperative day 1 to day 10.). 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 23 Sep 2026.