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

NCT ID: NCT03676114

Last Updated: 2018-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-20

Study Completion Date

2020-02-29

Brief Summary

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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

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ketamine group

Group Type EXPERIMENTAL

ketamine

Intervention Type DRUG

0.5mg/kg intravenous ketamine injection before incision followed by 0.25mg/kg/hr intravenous ketamine infusion during the operation

normal saline group

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Same volume of normal saline will be administrated

Interventions

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ketamine

0.5mg/kg intravenous ketamine injection before incision followed by 0.25mg/kg/hr intravenous ketamine infusion during the operation

Intervention Type DRUG

Normal saline

Same volume of normal saline will be administrated

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Han Yuan

OTHER

Sponsor Role lead

Responsible Party

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Han Yuan

Doctor-in-charge of Anesthetist

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Department of Anesthesia of the Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Junli Cao

Role: CONTACT

+86 15162160809

Yuan Han

Role: CONTACT

+86 13852470693

Facility Contacts

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Cao Junli

Role: primary

+86 15162160809

Han Yuan

Role: backup

+86 13852470693

Other Identifiers

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XuzhouMedSch3

Identifier Type: -

Identifier Source: org_study_id

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