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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03676114
• Other study ID #: XuzhouMedSch3
• Status: Recruiting
• Phase: Phase 4
• Start date: September 20, 2018
• Est. completion date: February 2020

Study information

• Verified date: September 2018
• Source: Xuzhou Medical University
• Contact: Junli Cao
• Phone: +86 15162160809
• Email: caojl0310[@]yahoo.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2020
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• ketamine
0.5mg/kg intravenous ketamine injection before incision followed by 0.25mg/kg/hr intravenous ketamine infusion during the operation
• Normal saline
Same volume of normal saline will be administrated

Locations

Country	Name	City	State
China	Department of Anesthesia of the Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Han Yuan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Chronic Pain	The incidence of chronic pain at 3 months after surgery	3 months after surgery
Secondary	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
Secondary	Postoperative complications	hallucination, nightmare and delirium will be recorded	Postoperative 1 day, 2 days and 3 days