Effect of Perioperative Low Dose Ketamine on Postoperative Recovery in Patients Undergoing Breast Cancer Surgery
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 breast-cancer
Started Sep 2018
Shorter than P25 for phase_4 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2018
CompletedFirst Posted
Study publicly available on registry
September 18, 2018
CompletedStudy Start
First participant enrolled
September 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedSeptember 21, 2018
September 1, 2018
1 year
September 5, 2018
September 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
ICFS scores
Postoperative 3 days, 7 days and 30 days
HADS scores
Postoperative 2 days and 3months
Chronic Pain
3 months after surgery
NRS pain scores
at 4 hours, 24 hours, and 48 hours after surgery
Postoperative complications
Postoperative 1 day, 2 days and 3 days
Study Arms (2)
ketamine group
EXPERIMENTALnormal saline group
PLACEBO COMPARATORInterventions
0.5mg/kg intravenous ketamine injection before incision followed by 0.25mg/kg/hr intravenous ketamine infusion during the operation
Eligibility Criteria
You may qualify if:
- American Society of Anesthesiologists Grade I-II
- Patients undergoing elective breast cancer surgery under general anesthesia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Han Yuanlead
Study Sites (1)
Department of Anesthesia of the Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Doctor-in-charge of Anesthetist
Study Record Dates
First Submitted
September 5, 2018
First Posted
September 18, 2018
Study Start
September 20, 2018
Primary Completion
October 1, 2019
Study Completion
February 1, 2020
Last Updated
September 21, 2018
Record last verified: 2018-09