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Evaluation of the Efficacy of Oral Moisturizing Solution on Postoperative Dry Mouth Symptoms in Patients Undergoing Elective Major Surgery under General Anesthesia

Efficacy of Oral Repair Solution on Postoperative Xerostomia in Patients Undergoing Elective Major Surgery under General Anesthesia: A Randomized, Double-Blind, Placebo-Controlled, Single-Center Clinical Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600129186
Enrollment
Unknown
Registered
2026-07-31
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Dry mouth after a major surgery under general anesthesia

Interventions

Control group:Moisten the mouth with 2 ml of normal saline. Use a clean cotton swab to moisten the inner walls of the patient's mouth and the upper and lower lips. Repeat this process three times to e
Oral Restoration Solution Group:Apply 2 ml of the repair solution to the mouth. Use a clean cotton swab to moisten the inner and outer walls of the patient's mouth as well as the upper and lower lips.

Sponsors

The First Affiliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Age 18-75; 2.ASA classification I-III; 3.Elective major surgery under general anesthesia (surgery duration >=2 hours);

Exclusion criteria

Exclusion criteria: 1.Had dry mouth symptoms before surgery (Schirmer test <5mm/5min) or Sjogren's syndrome; 2.Active oral ulcers or fungal infections; 3.Long-term use of drugs that cause dry mouth, like anticholinergics or antidepressants; 4.Refusal to use oral moisturizing solutions; 5.Patient has cognitive impairment or other mental health issues;

Design outcomes

Primary

MeasureTime frame
Highest xerostomia score at 6 hours postoperatively;

Secondary

MeasureTime frame
Quality of recovery at 24 hours postoperatively (QoR15);Incidence of postoperative nausea and vomiting (PONV);Thirst and xerostomia scores at 30 min, 1 h, 2 h, and 6 h postoperatively;

Countries

China

Contacts

Public ContactPeng Ke

The First Affiliated Hospital of Soochow University

2448814165@qq.com+86 512 65223637

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026