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
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: ketamine Drug: Normal saline||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Experimental: ketamine group||
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
- 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).
- 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.
- 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.
- Chronic Pain [ Time Frame: 3 months after surgery ]The incidence of chronic pain at 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.
- Postoperative complications [ Time Frame: Postoperative 1 day, 2 days and 3 days ]hallucination, nightmare and delirium will be recorded
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
|Contact: Junli Cao||+86 email@example.com|
|Contact: Yuan Han||+86 firstname.lastname@example.org|
|Department of Anesthesia of the Affiliated Hospital of Xuzhou Medical University||Recruiting|
|Xuzhou, Jiangsu, China|
|Contact: Cao Junli +86 15162160809 email@example.com|
|Contact: Han Yuan +86 13852470693 firstname.lastname@example.org|