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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
ketamine
Normal saline
Sponsored by
Han Yuan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Ketamine, Breast Cancer Surgery, Postoperative Recovery

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Anesthesia of the Affiliated Hospital of Xuzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ketamine group

normal saline group

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

ICFS scores
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
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
The incidence of chronic pain at 3 months after surgery
NRS pain scores
Evaluate the severity using numerical rating scale（NRS）, where zero mean no pain and 10 the worst imaginable pain.
Postoperative complications
hallucination, nightmare and delirium will be recorded

Full Information

First Posted
September 5, 2018
Last Updated
September 19, 2018
Sponsor
Han Yuan
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1. Study Identification

Unique Protocol Identification Number
NCT03676114
Brief Title
Effect of Perioperative Low Dose Ketamine on Postoperative Recovery in Patients Undergoing Breast Cancer Surgery
Official Title
Effect of Perioperative Low Dose Ketamine on Postoperative Recovery in Patients Undergoing Breast Cancer Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 20, 2018 (Actual)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
February 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Han Yuan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Ketamine, Breast Cancer Surgery, Postoperative Recovery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ketamine group
Arm Type
Experimental
Arm Title
normal saline group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ketamine
Intervention Description
0.5mg/kg intravenous ketamine injection before incision followed by 0.25mg/kg/hr intravenous ketamine infusion during the operation
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Same volume of normal saline will be administrated
Primary Outcome Measure Information:
Title
QoR40 score
Description
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).
Time Frame
the first day after surgery
Secondary Outcome Measure Information:
Title
ICFS scores
Description
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.
Time Frame
Postoperative 3 days, 7 days and 30 days
Title
HADS scores
Description
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.
Time Frame
Postoperative 2 days and 3months
Title
Chronic Pain
Description
The incidence of chronic pain at 3 months after surgery
Time Frame
3 months after surgery
Title
NRS pain scores
Description
Evaluate the severity using numerical rating scale（NRS）, where zero mean no pain and 10 the worst imaginable pain.
Time Frame
at 4 hours, 24 hours, and 48 hours after surgery
Title
Postoperative complications
Description
hallucination, nightmare and delirium will be recorded
Time Frame
Postoperative 1 day, 2 days and 3 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists Grade I-II Patients undergoing elective breast cancer surgery under general anesthesia Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Junli Cao
Phone
+86 15162160809
Email
caojl0310@yahoo.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yuan Han
Phone
+86 13852470693
Email
hanyuan-trial@163.com
Facility Information:
Facility Name
Department of Anesthesia of the Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cao Junli
Phone
+86 15162160809
Email
caojl0310@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Han Yuan
Phone
+86 13852470693
Email
hanyuan_trial@163.com

12. IPD Sharing Statement

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

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