Intraperitoneal Dexamethasone Spraying on Vagal Nerve-Rich Areas for Prevention of Hoarseness After Upper Abdominal Surgery
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.
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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: KAIGE SHI
- 전화번호: +86-18259992395
- 이메일: shikg2001@163.com
연구 장소
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Fujian
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Fuzhou, Fujian, 중국
- 모병
- Fujian Medical University Union Hospital
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연락하다:
- Shi
- 전화번호: +86-18259992395
- 이메일: shikg2001@163.com
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Fuzhou, Fujian, 중국
- 아직 모집하지 않음
- Mengchao Hepatobiliary Hospital of Fujian Medical University
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연락하다:
- Yan
- 전화번호: +86-18850377157
- 이메일: mcgdyyll@126.com
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Quanzhou, Fujian, 중국
- 아직 모집하지 않음
- The Second Affiliated Hospital of Fujian Medical University
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연락하다:
- He
- 전화번호: +86-15905921859
- 이메일: 15905921859@163.com
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Jiangxi
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Nanchang, Jiangxi, 중국
- 아직 모집하지 않음
- The First Affiliated Hospital of Nanchang University
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연락하다:
- Min
- 전화번호: +86-0791-88692748
- 이메일: candymin66@163.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Dexamethasone Prophylaxis Group
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. |
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. |
|
위약 비교기: Placebo Control Group
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. |
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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence of postoperative hoarseness within 10 days
기간: Postoperative day 1 to day 10.
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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. |
Postoperative day 1 to day 10.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Time to recovery from hoarseness
기간: From first diagnosis of hoarseness (GRBAS G ≥2) to recovery of voice (GRBAS G <2), assessed up to postoperative day 10.
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From first diagnosis of hoarseness (GRBAS G ≥2) to recovery of voice (GRBAS G <2), assessed up to postoperative day 10.
|
|
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Change in objective voice acoustic parameters measured by Praat software
기간: Postoperative day 1 to day 10.
|
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. |
Postoperative day 1 to day 10.
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Change in Grade, Roughness, Breathiness, Asthenia, and Strain (GRBAS) scale subscores over time
기간: Postoperative day 1 to day 10.
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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. |
Postoperative day 1 to day 10.
|
공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: ZHONGMENG LAI, Fujian Medical University Union Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2026KY683-02
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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