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The exploration of the improvement of depressive mood and safety in patients with renal failure secondary to hyperparathyroidism undergoing surgery with low-dose esketamine during the operation

The exploration of the improvement of depressive mood and safety in patients with renal failure secondary to hyperparathyroidism undergoing surgery with low-dose esketamine during the operation

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118351
Enrollment
Unknown
Registered
2026-02-04
Start date
2025-10-13
Completion date
Unknown
Last updated
2026-02-09

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

Conditions

Renal failure leading to hyperparathyroidism

Interventions

The esketamine experimental group:Dilute 0.25 mg/kg of esketamine to 20 ml. Complete the infusion within 40 minutes after skin incision.
Saline control group:Infuse an equal amount of 20 mL of normal saline within 40 minutes after the skin incision.

Sponsors

The Second Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18 - 65 years old; 2. American Society of Anesthesiologists (ASA) physical condition: III - IV; 3. Diagnosed with chronic renal failure secondary to hyperparathyroidism and requiring surgical treatment; 4. Voluntarily participated in this study and signed the informed consent form; 5. Screening was conducted using the Questionnaire-9 (PHQ-9) and the Montgomery-Asberg Depression Rating Scale (MADRS). A PHQ-9 score of >= 5 points and a MADRS score of >= 12 points indicated mild to severe depressive symptoms;

Exclusion criteria

Exclusion criteria: 1. Have severe cardiovascular diseases (such as severe arrhythmia, heart failure, etc.); unstable ischemic heart disease, severe pulmonary hypertension; 2. Have a history of mental illness (such as schizophrenia, mania, etc.) or are currently taking anti-psychotic drugs; used analgesics and sedatives before the surgery; 3. Have a history of epilepsy or have a high risk of epilepsy; 4. Pregnant or lactating women; 5. Unable to cooperate with the scoring of observation indicators; 6. Complicated with other serious systemic diseases, such as severe liver dysfunction, advanced malignant tumors, etc., which may affect the evaluation of the trial results; 7. Body Mass Index (BMI) > 30 kg/m^2; 8. Liver dysfunction (alanine aminotransferase or aspartate aminotransferase value is twice the upper limit of normal or total bilirubin > 1.5 times the upper limit of normal); 9. Elevated intracranial pressure or intraocular pressure, chronic pain, mental illness or history of alcohol abuse;

Design outcomes

Primary

MeasureTime frame
The proportion of patients whose Montgomery-?sberg depression score decreased by at least 50% within 3 days after the surgery;;

Secondary

MeasureTime frame
The heart rate (HR) at the corresponding time point, the mean arterial pressure (MAP), and the number of times when MAP was less than 65 mmHg;;Improvement of depressive mood;Pain NRS score;The intraoperative PETCO2, peak airway pressure (Ppeak), minute ventilation volume (MV), and oxygenation index (SpO2) at the corresponding time point;The length of time that postoperative patients stay in the PACU;The occurrence of adverse events within 3 days after the operation (such as nausea and vomiting, dizziness, delirium, respiratory depression, hallucinations, nightmares, chills, diplopia, deterioration of renal function, etc.);Record the time for gastrointestinal function recovery (the time of first defecation and flatus passage);The dosage of vasoactive drugs used during the operation; the dosage of anesthesia maintenance drugs and analgesic drugs; the usage of postoperative analgesic drugs (such as the dosage of opioid drugs used in the patient-controlled intravenous analgesia pump);Simplified Postoperative Recovery Quality of Life Scale QoR-15 score;

Countries

China

Contacts

Public ContactJiang Lingling

The Second Affiliated Hospital of Anhui Medical University

lamar_00@126.com+86 138 6611 1607

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026