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

H

Han Yuan

Status and phase

Unknown
Phase 4

Conditions

Breast Cancer

Treatments

Drug: ketamine
Drug: Normal saline

Study type

Interventional

Funder types

Other

Identifiers

NCT03676114
XuzhouMedSch3

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

Female

Ages

20 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

100 participants in 2 patient groups, including a placebo group

ketamine group
Experimental group
Treatment:
Drug: ketamine
normal saline group
Placebo Comparator group
Treatment:
Drug: Normal saline

Trial contacts and locations

1

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Central trial contact

Yuan Han; Junli Cao

Data sourced from clinicaltrials.gov

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