NCT06773143 Effect of Subanesthetic Dose of Esketamine on Sleep Quality
| NCT ID | NCT06773143 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nanjing First Hospital, Nanjing Medical University |
| Condition | Insomnia |
| Study Type | INTERVENTIONAL |
| Enrollment | 184 participants |
| Start Date | 2024-12-30 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 184 participants in total. It began in 2024-12-30 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to explore whether subanesthetic doses of esketamine can improve the sleep quality of patients undergoing modified radical mastectomy for breast cancer. In this study, 184 people are expected to participate from admission to three days after surgery. The process requires participants to cooperate with the completion of the digital rating scale, the Athens Insomnia Scale, the Visual Analog Pain Rating Scale, the Hospital Anxiety and Depression Rating Scale, and the collection of venous blood for research indicators (IL-6, TNF-α, cor, BDNF). If participants agree to participate in this study, the investigators will assign a unique identification number to each participant and create a medical record for participants. One day before surgery, the investigators will conduct assessments using the Athens Insomnia Scale, the Visual Analog Pain Rating Scale, and the Hospital Anxiety and Depression Scale, and collect approximately 6 mL of venous blood. One day after surgery, the investigators will repeat the assessments using the Athens Insomnia Scale, the Visual Analog Pain Rating Scale, and the Hospital Anxiety and Depression Scale. Additionally, the investigators will collect another 6 mL of venous blood and monitor the use of analgesics. The investigators will follow up with participants three days after the surgery. During this follow-up, investigators will assess any sleep disturbances, administer the Hospital Anxiety and Depression Scale, and review the use of analgesics.
Eligibility Criteria
Inclusion Criteria: 1. Patients diagnosed with breast cancer by pathology and immunohistochemistry 2. Patients receiving neoadjuvant chemotherapy 3. Age 18 to 65 years old; d) ; 4. ASA grade Ⅰ - Ⅲ 5. BMI 18 to 30 kg/m2 Exclusion Criteria: * 1: Patients refuse to participate in the study 2: BMI \> 30 kg/m2 3: Recent history of drug abuse 4: Allergy to or contraindications to esketamine 5: Cognitive dysfunction or inability to communicate 6: Severe dysfunction of important organs such as liver and kidney function
Contact & Investigator
xiaoliang wang
STUDY DIRECTOR
The First Affiliated Hospital with Nanjing Medical University
Frequently Asked Questions
Who can join the NCT06773143 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 65 Years, studying Insomnia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06773143 currently recruiting?
Yes, NCT06773143 is actively recruiting participants. Contact the research team at 1395626955@qq.com for enrollment information.
Where is the NCT06773143 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT06773143 clinical trial?
NCT06773143 is sponsored by Nanjing First Hospital, Nanjing Medical University. The principal investigator is xiaoliang wang at The First Affiliated Hospital with Nanjing Medical University. The trial plans to enroll 184 participants.
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