Effect of Esketamine on Perioperative Negative Emotions in Patients Undergoing Breast Cancer Surgery

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• Depression 8,059
• Anxiety Disorders 4,874
• Breast Neoplasms 12,547

Depression

8,059 studies on the registry are indexed under Depression; 1,643 are open to participants now.

This study's planned enrollment of 218 is above the median of 84 across 6,722 interventional studies indexed under Depression.

Lead sponsor

Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.

Study arms

• Experimental
  Esketamine group

  Patients who undergo general anesthesia using esketamine.

  Drug: Esketamine 0.3mg/kg

• Placebo comparator
  Control group

  Patients who undergo general anesthesia without esketamine

  Drug: Normal Saline

Interventions

• DrugEsketamine 0.3mg/kg

  A single dose of 0.3 mg/kg esketamine is administered intravenously during anesthesia induction, with the infusion completed over 40 minutes.

• DrugNormal Saline

  Receiving the same volume of normal saline during induction of anesthesia during the same time

Primary outcomes

1. Perioperative anxiety and depreession

   The primary outcomes were depression and anxiety, which were assessed using the Hospital Anxiety and Depression Scale (HADS). Perioperative anxiety was measured using the Hospital Anxiety and Depression Scale-Anxiety (HADS-A) subscale, a standardized self-report instrument consisting of 7 items. Patients with a HADS-A score of 8 or more were considered to be experiencing anxiety, with a score of 8 to 10 indicating mild anxiety, 11 to 14 indicating moderate anxiety, and 15 to 21 indicating severe anxiety. Perioperative depression was measured using the Hospital Anxiety and Depression Scale-Depression (HADS-D) subscale. Patients with a HADS-D score of 8 or more were considered to be experiencing depression, with a score of 8 to 10 indicating mild depression, 11 to 14 indicating moderate depression, and 15 to 21 indicating severe depression.

   Time frame: Preoperative day 1, postoperative day 3, day 7 and day 30

Secondary outcomes

1. Postoperative Sleep Quality

   Postoperative sleep quality was assessed using the Insomnia Severity Index (ISI). The ISI is a simple tool used to screen for insomnia and consists of 7 items to assess the nature and symptoms of the subject\'s sleep disorder on a 5-point Likert scale, with each item scored from 0 to 4 and the total score ranging from 0 to 28, with higher scores indicating greater severity of insomnia. The sum of the scores with 0-7 indicating insomnia without clinical significance, 8-14 indicating subclinical insomnia, 15-21 indicating clinical insomnia (moderate), 22-28 indicating 'clinical insomnia (moderate), and 22-28 indicating clinical insomnia (moderate). A score of 8 to 14 indicates subclinical insomnia, a score of 15 to 21 indicates clinical insomnia (moderate), and a score of 22 to 28 indicates clinical insomnia (severe).

   Time frame: postoperative day 3, day 7 and day 30

2. Delirium

   Delirium was assessed using a combination of the 3-Minute Diagnostic Interview for CAM (3D-CAM) and the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Patients in the general ward were assessed using the 3D-CAM, while patients in the intensive care unit were assessed using the CAM-ICU. Delirium consists of four main features: acute altered mental status or fluctuating level of consciousness, inattention, disorganized thinking, and altered level of consciousness. Patients were diagnosed with postoperative delirium if both the first and second features were present, and either the third or fourth feature was also present.

   Time frame: Within 7 days after surgery]

3. PONV

   Postoperative nausea and vomiting (PONV) were assessed using a visual analogue scale (VAS). This scale consists of a 10-centimeter straight line, with 0 indicating no nausea and vomiting, and 10 indicating the most extreme level of nausea and vomiting that can be endured. The severity of PONV is categorized as follows: mild (1 to 4), moderate (5 to 6), and severe (7 to 10).

   Time frame: Within 2 days after extubation

4. Postoperative Recovery Quality

   Postoperative quality of recovery was evaluated using the Chinese version of the Quality of Recovery-15 (QoR-15) score. This assessment tool comprises 15 items, each scored on a 10-point scale. The total score ranges from 0 to 150, with 0 indicating poor recovery and 150 signifying an excellent quality of recovery

   Time frame: Postoperative day 3,day 7 and day 30

5. Postoperative Pain

   Assessment was conducted using the Numerical Rating Scale (NRS) for pain, which ranges from 0 to 10. On this scale, a score of 0 represents the absence of pain, while a score of 10 represents the most severe pain.

   Time frame: Postoperative day 3,day 7 and day 30

6. Postoperative Quality of Life

   Postoperative quality of life was assessed using the EuroQol 5-Dimension questionnaire (EQ-5D). This instrument evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For the descriptive system, each dimension is typically rated using a three-level scale (no problems, some problems, extreme problems) or a five-level scale (no problems, slight problems, moderate problems, severe problems, extreme problems).The responses are combined to form a 5-digit health state profile (e.g., 11111 for no problems in any dimension). This profile is then converted into a single summary number called the EQ-5D index score, using a country-specific value set. The theoretical range of the index score is approximately from -0.594 (worst imaginable health state, considered worse than death) to 1.0 (perfect health), with 0 representing a health state equivalent to death. Therefore, a higher EQ-5D index score indicates a better quality of life.

   Time frame: Postoperative day 3,day 7 and day 30

Other outcomes

1. Intraoperative blood pressure

   Intraoperative blood pressure#MAP in mmHg/SBP in mmHg/DBP in mmHg) at T0 (before induction of anesthesia), T1 (5 min after esketamine or control infusion), T2 (30 min after esketamine or control infusion), T3 (1 h after esketamine or control infusion), T4 (3 h after esketamine or control infusion), and T5(at the end of surgery) were included.

   Time frame: During the surgery

2. Intraoperatively heart rate

   Intraoperative heart rate#HR in bmp) at T0 (before induction of anesthesia), T1 (5 min after esketamine or control infusion), T2 (30 min after esketamine or control infusion), T3 (1 h after esketamine or control infusion), T4 (3 h after esketamine or control infusion), and T5(at the end of surgery) were included.

   Time frame: During the surgery

3. Perioperative inflammatory factor (IL-6)

   Inflammatory factor (IL-6 in pg/ml) were from laboratory tests in the patient's medical record.

   Time frame: perioperatively

4. Perioperative inflammatory factor (CRP)

   Inflammatory factor (CRP in mg/dl) were from laboratory tests in the patient's medical record.

   Time frame: perioperatively

5. Perioperative brain injury-related factor (S100β)

   Brain injury-related factor (S100β in ng/ml)

   Time frame: perioperatively

6. Perioperative brain-derived neurotrophic factor (BDNF)

   Brain-derived neurotrophic factor (BDNF in ng/ml)

   Time frame: perioperatively

7. Perioperative acetylcholine (Ach)

   Acetylcholine (Ach in ng/ml)

   Time frame: perioperatively

8. Perioperative norepinephrine (NE)

   Norepinephrine(NE in ng/ml)

   Time frame: perioperatively

Individual participant data

Plan to share: No