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

September 19, 2018 updated by: Han Yuan
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Xuzhou, Jiangsu, China
        • Recruiting
        • Department of Anesthesia of the Affiliated Hospital of Xuzhou Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ketamine group
Drug: ketamine
0.5mg/kg intravenous ketamine injection before incision followed by 0.25mg/kg/hr intravenous ketamine infusion during the operation
PLACEBO_COMPARATOR: normal saline group
Drug: Normal saline
Same volume of normal saline will be administrated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
the first day after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Postoperative 3 days, 7 days and 30 days
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.
Postoperative 2 days and 3months
Chronic Pain
Time Frame: 3 months after surgery
The incidence of chronic pain at 3 months after surgery
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.
at 4 hours, 24 hours, and 48 hours after surgery
Postoperative complications
Time Frame: Postoperative 1 day, 2 days and 3 days
hallucination, nightmare and delirium will be recorded
Postoperative 1 day, 2 days and 3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Han Yuan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 20, 2018

Primary Completion (ANTICIPATED)

October 1, 2019

Study Completion (ANTICIPATED)

February 1, 2020

Study Registration Dates

First Submitted

September 5, 2018

First Submitted That Met QC Criteria

September 15, 2018

First Posted (ACTUAL)

September 18, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 21, 2018

Last Update Submitted That Met QC Criteria

September 19, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XuzhouMedSch3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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