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

Phase 4

• Conditions: Breast Cancer
• Interventions: Drug: ketamine; Drug: Normal saline

• Registration Number: NCT03676114
• Lead Sponsor: Han Yuan

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-09
• Study First Submitted: 2018-09-05
• Study First Submitted QC: 2018-09-15
• Study First Posted: 2018-09-18
• Last Update Submitted: 2018-09-19
• Study Start: 2018-09-20
• Last Update Posted: 2018-09-21
• Primary Completion: 2019-10
• Study Completion: 2020-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ketamine group	ketamine	-
normal saline group	Normal saline	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.
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

Trial Locations

Locations (1)

Department of Anesthesia of the Affiliated Hospital of Xuzhou Medical University; 🇨🇳 Xuzhou, Jiangsu, China