Breast Cancer
Conditions
Keywords
Ketamine, Breast Cancer Surgery, Postoperative Recovery
Brief summary
Breast cancer patients often have perioperative emotional disorders such as anxiety and depression, which can lead to poor quality of recovery.This study aims to determine whether ketamine could improve the quality of recovery in breast cancer patients. Meanwhile, it will show if ketamine could improve anxiety, depression, postoperative pain and fatigue.This trial also will bring great concerns on patients' mental health perioperatively and explore the measures to improve their quality of life.
Interventions
DRUGketamine
0.5mg/kg intravenous ketamine injection before incision followed by 0.25mg/kg/hr intravenous ketamine infusion during the operation
DRUGNormal saline
Same volume of normal saline will be administrated
Sponsors
Han Yuan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. American Society of Anesthesiologists Grade I-II 2. Patients undergoing elective breast cancer surgery under general anesthesia
Exclusion criteria
1. Unstable hypertension, history of heart disease 2. Hepatic or renal dysfunction 3. Patients undergoing chemotherapy before surgery 4. Have a history of chronic pain or chronic use of analgesic 5. Have mental illness or can't cooperate with investigators 6. Have a history of ketamine allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QoR40 score | the first day after surgery | Quality of recovery will be evaluated by Quality of Recovery 40 (QoR40),which assesses five dimensions of recovery (physical comfort,emotional state, physical independence , physiological support and pain ). Each item is rated on a five-point Likert scale: none of the time, some of the time, usually, most of the time, and all the time. The total score on the QoR40 ranges from 40 (poorest quality of recovery) to 200 (best quality of recovery). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICFS scores | Postoperative 3 days, 7 days and 30 days | Fatigue state will be evaluated by Identity Consequence Fatigue Scale (ICFS).ICFS is based on a score of 31-173, higher scores representing worse state of fatigue. |
| HADS scores | Postoperative 2 days and 3months | Perioperative emotion will be evaluated by the hospital anxiety and depression scale（HADS）.The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale. |
| Chronic Pain | 3 months after surgery | The incidence of chronic pain at 3 months after surgery |
| NRS pain scores | at 4 hours, 24 hours, and 48 hours after surgery | Evaluate the severity using numerical rating scale（NRS）, where zero mean no pain and 10 the worst imaginable pain. |
| Postoperative complications | Postoperative 1 day, 2 days and 3 days | hallucination, nightmare and delirium will be recorded |
Countries
China
Contacts
Primary ContactJunli Cao
Backup ContactYuan Han
Outcome results
None listed