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The Efficacy of Perioperative Hormone Therapy in Relieving Post-tonsillectomy Pain:a Multicenter Single-Blind Randomized Controlled Trial

The Efficacy of Perioperative Hormone Therapy in Relieving Post-tonsillectomy Pain:a Multicenter Single-Blind Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117808
Enrollment
Unknown
Registered
2026-01-29
Start date
2026-02-02
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Obstructive sleep apnea

Interventions

Low-dose preoperative 1 h + normal postoperative administration group (Group A):Dexamethasone at a dose of 0.05 mg/kg was administered intravenously to the patient 1 h +/- 5 min before surgery, and th
Low-dose surgery group starting + postoperative normal medication group (Group B):Dexamethasone is administered intravenously at a dose of 0.05 mg/kg to the patient when the surgery begins to cut the
High-dose preoperative 1h + normal postoperative administration group (Group C):Dexamethasone at a dose of 0.1 mg/kg was administered intravenously to the patient 1 h ± 5 min before surgery, and then
High-dose surgery group + postoperative normal dose group (Group D):Dexamethasone is administered intravenously at a dose of 0.1 mg/kg to the patient when the surgery begins to cut the skin, and then
Control group :Saline solution was administered intravenously as a placebo before surgery. Since patients were unaware of the administration during and after the surgery, no placebo effect was observe

Sponsors

Beijing Tsinghua Changgung Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Patients are diagnosed with obstructive sleep apnea (OSA), with airway obstruction at the oropharyngeal level, and do not have severe hypoxemia (nighttime minimum blood oxygen cannot be below 60%); 2.Age range: 18 to 65 years old, to ensure the maturity and homogeneity of the research subjects; 3.No history of hormone treatment before surgery, or no use of hormones within at least 2 weeks before surgery; patients without severe systemic diseases, such as heart disease, liver and kidney dysfunction, etc., and able to tolerate surgery; 4.The maximum BMI of the subjects should not exceed 32, the maximum weight should not exceed 100 kg, and the maximum single dose should not exceed 10 mg; 5.Able to cooperate with postoperative pain assessment, such as filling out pain score scales; 6.All participants must fully understand the research content and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Hormone contraindications: Conditions such as active infections, active peptic ulcers, severe osteoporosis, severe mental illnesses, epilepsy, and others that may make patients unsuitable for hormone therapy; presence of hormone allergy symptoms. 2.Medication history: Recent use of medications that may affect study results, such as analgesics or corticosteroids. 3.Systemic diseases: Presence of severe systemic diseases that may affect study results, such as heart disease, moderate to severe hypertension, liver disease, kidney disease, etc. 4.Subjects with diabetes are not included in the study.

Design outcomes

Primary

MeasureTime frame
Visual Analogue Scale score;

Secondary

MeasureTime frame
Wound swelling grading;Use of analgesic dosage and first use time;The incidence of nausea and vomiting, bleeding, elevated blood sugar and blood pressure;

Countries

China

Contacts

Public ContactYin Guoping

Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua Medicine,Tsinghua University

yinguoping311@163.com+86 138 1142 3578

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026