Effect of Perioperative Low Dose Ketamine on Postoperative Recovery in Patients Undergoing Breast Cancer Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Perioperative Low Dose Ketamine on Postoperative Recovery in Patients Undergoing Breast Cancer Surgery

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: ketamine
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists Grade I-II Patients undergoing elective breast cancer surgery under general anesthesia Exclusion Criteria: Unstable hypertension, history of heart disease Hepatic or renal dysfunction Patients undergoing chemotherapy before surgery Have a history of chronic pain or chronic use of analgesic Have mental illness or can't cooperate with investigators Have a history of ketamine allergy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ketamine group<br> | Drug: ketamine<br>* 0.5mg/kg intravenous ketamine injection before incision followed by 0.25mg/kg/hr intravenous ketamine infusion during the operation<br>|
| Placebo Comparator: normal saline group<br> | Drug: Normal saline<br>* Same volume of normal saline will be administrated<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QoR40 score | 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). | the first day after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICFS scores | 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. | Postoperative 3 days, 7 days and 30 days | 
| HADS scores | 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. | Postoperative 2 days and 3months | 
| Chronic Pain | The incidence of chronic pain at 3 months after surgery | 3 months after surgery | 
| NRS pain scores | Evaluate the severity using numerical rating scale（NRS）, where zero mean no pain and 10 the worst imaginable pain. | at 4 hours, 24 hours, and 48 hours after surgery | 
| Postoperative complications | hallucination, nightmare and delirium will be recorded | Postoperative 1 day, 2 days and 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ketamine, Breast Cancer Surgery, Postoperative Recovery