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Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

Effect of low-dose ketamine on PerioperAtive depreSsive Symptoms in patients undergoing Intracranial tumOr resectioN (PASSION): study protocol for a randomized controlled trial

Authors: Yang Zhou, Yuming Peng, Jinghan Fang, Wanchen Sun, Guofu Zhang, Long Zhen, Gang Wang, Ruquan Han

Published in: Trials | Issue 1/2018

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Abstract

Background

Perioperative depressive symptoms (PDS) are common mental comorbidities that influence clinical outcomes and prognosis. However, there is no rapid-acting treatment to address these symptoms during a limited hospital stay.

Methods/design

This is a single-center, randomized, placebo-controlled, and double-blind trial. Randomization will be applied and stratified by the severity of PDS (moderate versus severe). Eighty patients who are scheduled for elective supratentorial brain tumor resection with PDS will be randomly allocated to the ketamine or placebo group with a ratio of 1 to 1. Patients in the ketamine group will be administered low-dose ketamine (0.5 mg/kg) intravenously for 40 min while the dural mater is being cut into, whereas patients in the placebo group will receive the same volume of normal saline at the same infusion rate at the same time points. The primary endpoint is the rate of PDS response at 3 days after surgery. Secondary outcomes include efficacy parameters such as the rate of PDS remission and safety outcomes such as the incidence of postoperative delirium, quality of recovery, and psychiatric side effects.

Discussion

This study aims to determine whether ketamine could improve the depressive symptoms of perioperative patients undergoing supratentorial brain tumor resection. It will also examine the safety of administering ketamine as an intraoperative anti-depressant.

Trial registration

ClinicalTrials.gov, NCT03086148. Registered on 22 March 2017.
Appendix
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Metadata
Title
Effect of low-dose ketamine on PerioperAtive depreSsive Symptoms in patients undergoing Intracranial tumOr resectioN (PASSION): study protocol for a randomized controlled trial
Authors
Yang Zhou
Yuming Peng
Jinghan Fang
Wanchen Sun
Guofu Zhang
Long Zhen
Gang Wang
Ruquan Han
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2831-0

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