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

Ketamine

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.

Intervention / Treatment

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

Condition or Disease

  • Breast Cancer

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: 20 Years to 65 Years
    Enrollment: 100 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Sep 20, 2018 ACTUAL
    Primary Completion: Oct 01, 2019 ESTIMATED
    Completion Date: Feb 01, 2020 ESTIMATED
    Study First Posted: Sep 18, 2018 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Sep 19, 2018

    Sponsors / Collaborators

    Lead Sponsor: Han Yuan
    Responsible Party: Han Yuan

    Location

    Jiangsu, China
    Xuzhou, Jiangsu, China

    Participant Groups

    • No description provided

    • No description provided

    Eligibility Criteria

    Sex: Female
    Minimum Age: 20
    Maximum Age: 65
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • 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 Outcomes

    • 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.

    • 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.

    • The incidence of chronic pain at 3 months after surgery

    • Evaluate the severity using numerical rating scale（NRS）, where zero mean no pain and 10 the worst imaginable pain.

    • hallucination, nightmare and delirium will be recorded

    More Details

    NCT Number: NCT03676114
    Other IDs: XuzhouMedSch3
    Study URL: https://clinicaltrials.gov/study/NCT03676114
    Last updated: Sep 29, 2023