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To compare the effects of preoperative oral midazolam combined with different modes of esketamine administration on the quality of postoperative recovery in patients undergoing thyroid surgery

To compare the effects of preoperative oral midazolam combined with intraoperative single intravenous or nasal esketamine on the quality of postoperative recovery in patients undergoing thyroid surgery

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104018
Enrollment
Unknown
Registered
2025-06-10
Start date
2024-04-15
Completion date
Unknown
Last updated
2025-06-16

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

Conditions

Thyroid cancer

Interventions

Group E1:Esketamine 0.4mg/kg intravenously is given at the time of anesthesia induction
Group E2:Esketamine 0.8mg/kg nasal drops were given at the time of anesthesia induction
Group C:Intravenous injection of the same amount of normal saline at the time of anesthesia induction

Sponsors

The First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18-65 years; (2) Deviation from ideal body weight <= 25%; (3) American Society of Anesthesiologists ASA I - II; (4) Duration of surgery less than 3 hours for thyroid surgery patients; (5) No history of long-term use of analgesics, sedatives, or anxiolytics;

Exclusion criteria

Exclusion criteria: (1) Patients with known allergy to esketamine; Patients at severe risk of elevated blood pressure or intracranial pressure; Patients with known allergies to midazolam or benzodiazepines, acute closed-eye glaucoma, or open-angle glaucoma without effective treatment; (2) Body weight exceeds the ideal body weight by +/-25%; (3) Patients with any serious systemic organ disease (cardiopulmonary/kidney/liver), neurological disease (cerebral palsy, autism, etc.), or combined use of anesthetics or other central nervous system inhibitors; (4) Patients who have taken any drug that may interfere with the pharmacokinetics or pharmacodynamics of midazolam, such as antifungals, macrolide antibiotics, cimetidine, rifamycin, or calcium channel blockers; (5) Patients with communication disorders, cognitive dysfunction, and a history of mental illness;

Design outcomes

Primary

MeasureTime frame
QOR-15 scale for quality of recovery score at 24 hours postoperatively;

Secondary

MeasureTime frame
Heart rate, blood oxygen saturation, and blood pressure before oral midazolam, 10 min, 20 min after taking the drug, and before anesthesia induction;Visual Analogue Scale (VAS) score for pain at 6, 12, 24h postoperatively;Patient's sleep on the first night after surgery (Athens Insomnia Scale AIS);Hospital Anxiety and Depression Scale (HADS) 24 hours postoperatively;The amount of anesthetic used: sedatives such as propofol, and the amount of analgesics such as sufentanil and remifentanil;Nausea, vomiting, delirium and other adverse events occurred within 24 hours after surgery;Anxiety Visual Analogue Scale (VAS-A) and Ramsay score before oral midazolam, 10 min and 20 min after taking the drug, and before anesthesia induction;

Countries

China

Contacts

Public ContactGuanghong Xu

The First Affiliated Hospital of Anhui Medical University

xuguanghong2004@163.com+86 138 5694 9535

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026