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

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ClinicalTrials.gov Identifier: NCT03676114
Recruitment Status : Unknown
Verified September 2018 by Han Yuan, Xuzhou Medical University.
Recruitment status was:  Recruiting
First Posted : September 18, 2018
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
Han Yuan, Xuzhou Medical University

Tracking Information
First Submitted Date  ICMJE September 5, 2018
First Posted Date  ICMJE September 18, 2018
Last Update Posted Date September 21, 2018
Actual Study Start Date  ICMJE September 20, 2018
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2018)
QoR40 score [ Time Frame: 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2018)
  • ICFS scores [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 3 months after surgery ]
    The incidence of chronic pain at 3 months after surgery
  • NRS pain scores [ Time Frame: 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 [ Time Frame: Postoperative 1 day, 2 days and 3 days ]
    hallucination, nightmare and delirium will be recorded
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Perioperative Low Dose Ketamine on Postoperative Recovery in Patients Undergoing Breast Cancer Surgery
Official Title  ICMJE Effect of Perioperative Low Dose Ketamine on Postoperative Recovery in Patients Undergoing Breast Cancer Surgery
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: ketamine
    0.5mg/kg intravenous ketamine injection before incision followed by 0.25mg/kg/hr intravenous ketamine infusion during the operation
  • Drug: Normal saline
    Same volume of normal saline will be administrated
Study Arms  ICMJE
  • Experimental: ketamine group
    Intervention: Drug: ketamine
  • Placebo Comparator: normal saline group
    Intervention: Drug: Normal saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 15, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2020
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03676114
Other Study ID Numbers  ICMJE XuzhouMedSch3
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Han Yuan, Xuzhou Medical University
Study Sponsor  ICMJE Han Yuan
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Xuzhou Medical University
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP