Effect of Subanesthetic Dose of Esketamine on Sleep Quality
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorNanjing First Hospital, Nanjing Medical University
About this trial
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
This trial does not accept healthy volunteersQualifiers
Patients diagnosed with breast cancer by pathology and immunohistochemistry
Patients receiving neoadjuvant chemotherapy
Age 18 to 65 years old; d) ;
ASA grade Ⅰ - Ⅲ
Disqualifiers
1: Patients refuse to participate in the study
Trial design
Design model
Parallel
Treatments tested in this trial
Esketamine at low dose
DrugAfter the induction of general anesthesia, patients in the esketamine group will receive a continuous infusion of esketamine (0.3 mg/kg/h) until the end of the operation.
Normal Saline (0.9% NaCl)
Other interventionAfter the patient's general anesthesia induction is completed, normal saline will be continuously infused until the end of the operation, and the infusion volume is the same as that of the esketamine group.
Treatment groups
184 Participants
are divided into 2 treatment groupsGroup A: esketamine groupExperimental treatment 1 intervention
Group B: control groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
The incidence of PSD on postoperative day -1
On the first day after surgery, NRS ≥ 6 or AIS ≥ 6.PSD is defined as a numeric rating scale (NRS) ≥6 or Athens Insomnia Scale (AIS) ≥6, indicating that sleep is repeatedly disturbed or worse throughout the night. NRS scores range from 0 to 10, with 0 representing excellent or good sleep and 10 representing inability to sleep all night. AIS consists of 8 items: nighttime awakenings, sleep induction, final awakening, total sleep time, sleep quality, well-being, functional ability, and daytime sleepiness.
Time frame
the first day after surgerySecondary outcomes
1
static Visual Analog Scale score on postoperative day -2
The painful visual simulation table of pain is a tool for evaluating the strength of pain. It is usually composed of a 10 -centimeter straight line. The two ends are marked as "painless" and "most pain". Patients are marked on the straight line according to their degree of pain.
Time frame
on postoperative day -22
dynamic Visual Analog Scale score on postoperative day -2
The painful visual simulation table of pain is a tool for evaluating the strength of pain. It is usually composed of a 10 -centimeter straight line. The two ends are marked as "painless" and "most pain". Patients are marked on the straight line according to their degree of pain.
Time frame
on postoperative day -23
anxiety and depression score on the day before surgery
The hosp Anxiety and depression scale is a self-evaluation table commonly used in evaluation of anxiety and depression . It contains 14 problems, divided into two sub-meters, and each sub-meter contains 7 items: Anxious sub -meter: Evaluate the anxiety experience of patients in the past week. Depression Meter: Evaluate the depression experience of patients in the past week. Each problem has four levels of options, corresponding to different scores, usually 0 to 3 points. The scoring standard is as follows: 0-7 points: normal 8-10 points: may be mild depression/anxiety
Time frame
the day before surgery4
The incidence of PSD on postoperative day -3
On the third day after surgery, NRS ≥ 6 or AIS ≥6.
Time frame
he third day after surgeryOther outcomes
1
IL-6 blood on the day before surgery
Time frame
the day before surgery2
TNFα on the day before surgery
Time frame
the day before surgery3
BDNF on the day before surgery
Time frame
the day before surgerySponsors and contacts
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Source ClinicalTrials.gov