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Clinical Trial of Growth Factor (FGF) for the Prevention of Postoperative Sore Throat Following Tracheal Intubation: A Single-Center, Randomized, Double-Blind, Controlled Clinical Study

Clinical Trial of Growth Factor (FGF) for the Prevention of Postoperative Sore Throat Following Tracheal Intubation: A Single-Center, Randomized, Double-Blind, Controlled Clinical Study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127693
Enrollment
Unknown
Registered
2026-07-06
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Sore Throat, POST

Interventions

rh-bFGF group:A trained anesthesiologist, who is blinded to group allocation and wears sterile gloves, will use a specialized sterile swab to dip into rh-bFGF gel (approximately the size of a peanut,
Control group:A trained anesthesiologist, who is blinded to group allocation and wears sterile gloves, will use a specialized sterile swab to dip into a placebo gel (same dosage as the experimental gr

Sponsors

The First Affiliated Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. American Society of Anesthesiologists (ASA) physical status classification I to III. 2. Age between 18 and 65 years. 3. Patients scheduled for elective surgeries requiring general anesthesia with tracheal intubation, specifically:Laparoscopic radical resection of colorectal cancer, Vocal cord lesion resection via suspension laryngoscopy, Thoracoscopic radical resection of lung cancer, Radical thyroidectomy.

Exclusion criteria

Exclusion criteria: 1. History of airway-related conditions: Pre-existing sore throat, recent respiratory tract infection, cough, asthma, preoperative hoarseness, or a history of airway radiotherapy or surgery. 2. Coagulation disorders. 3. Dental or airway pathology: Loose teeth or congenital/acquired upper airway abnormalities (e.g., tumors, polyps, trauma, abscesses, inflammation). 4. High risk of regurgitation and aspiration: Such as gastroesophageal reflux disease. 5. Allergy to the study drug. 6. Recent use of analgesic medications. 7. Anticipated difficult airway, inability to cooperate, or inability to perform study assessments/scoring.

Design outcomes

Primary

MeasureTime frame
the incidence of moderate-to-severe POST (VAS >= 4) at 1 hour postoperatively;

Secondary

MeasureTime frame
the four-point pain scale and VAS score for POST at 1h, 6h, 12h, and 24h postoperatively;swallowing function;hoarseness;The presence, location, and severity of injuries to the pharynx, laryngeal inlet, and vocal cords.; the presence (yes/no) and duration (in hours/days) of postoperative hoarseness, after excluding other potential causes;hemodynamic and oxygenation parameters (blood pressure, oxygen saturation, and heart rate) measured before tracheal intubation, 1 minute after intubation, and after extubation;

Countries

China

Contacts

Public ContactHuang Luping

The First Affiliated Hospital of Wenzhou Medical University

308893839@qq.com+86 135 8789 1399

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026