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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 : Recruiting
First Posted : September 18, 2018
Last Update Posted : September 20, 2018
Sponsor:
Information provided by (Responsible Party):
Han Yuan, Xuzhou Medical University

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: ketamine Drug: Normal saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Perioperative Low Dose Ketamine on Postoperative Recovery in Patients Undergoing Breast Cancer Surgery
Actual Study Start Date : September 20, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Ketamine

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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Chronic Pain [ Time Frame: 3 months after surgery ]
    The incidence of chronic pain at 3 months after surgery

  4. 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.

  5. Postoperative complications [ Time Frame: Postoperative 1 day, 2 days and 3 days ]
    hallucination, nightmare and delirium will be recorded



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03676114


Contacts
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Contact: Junli Cao +86 15162160809 caojl0310@yahoo.com.cn
Contact: Yuan Han +86 13852470693 hanyuan-trial@163.com

Locations
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China, Jiangsu
Department of Anesthesia of the Affiliated Hospital of Xuzhou Medical University Recruiting
Xuzhou, Jiangsu, China
Contact: Cao Junli    +86 15162160809    caojl0310@yahoo.com.cn   
Contact: Han Yuan    +86 13852470693    hanyuan_trial@163.com   
Sponsors and Collaborators
Han Yuan

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Responsible Party: Han Yuan, Doctor-in-charge of Anesthetist, Xuzhou Medical University
ClinicalTrials.gov Identifier: NCT03676114     History of Changes
Other Study ID Numbers: XuzhouMedSch3
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Han Yuan, Xuzhou Medical University:
Ketamine
Breast Cancer Surgery
Postoperative Recovery
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action