Effect of low-dose ketamine on PerioperAtive depreSsive Symptoms in patients undergoing Intracranial tumOr resectioN (PASSION): study protocol for a randomized controlled trial.
Yang Zhou, Yuming Peng, Jinghan Fang, Wanchen Sun, Guofu Zhang, Long Zhen, Gang Wang, Ruquan Han
Trials August 29, 2018 DOI: 10.1186/s13063-018-2831-0 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial (protocol) Placebo-controlled Double-blind Peer reviewed |
|---|---|
| Sample size | 80 |
| Population | Patients scheduled for elective supratentorial brain tumor resection with perioperative depressive symptoms (moderate or severe) |
| Intervention | Ketamine |
| Dose | 0.5 mg/kg intravenously over 40 min |
| Duration | Primary endpoint assessed at 3 days after surgery |
| Topics | Ketamine Esketamine |
| Keywords | Depression symptom Perioperative Randomized controlled trial |
| Registration | NCT03086148 |
| Key findings | The protocol aims to determine whether a single intraoperative low-dose ketamine infusion improves depressive symptoms in patients undergoing supratentorial brain tumor resection, and to assess its safety as an intraoperative antidepressant. No results are reported; the primary endpoint is the rate of depressive symptom response at 3 days after surgery. |
Abstract
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. 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. 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. ClinicalTrials.gov, NCT03086148 . Registered on 22 March 2017.
Comparable studies
Other randomized controlled trials on ketamine, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Subanesthetic Effects of the Noncompetitive NMDA Antagonist, Ketamine, in Humans Healthy human subjects recruited from the community | 1994 | Randomized controlled trial | n = 19 |
| Antidepressant Efficacy of Ketamine in Treatment-Resistant Major Depression: A Two-Site Randomized Controlled Trial Patients with treatment-resistant major depression experiencing a major depressive episode | 2013 | Randomized controlled trial | n = 73 |
| Remifentanil-induced Postoperative Hyperalgesia and Its Prevention with Small-dose Ketamine Patients undergoing major abdominal surgery | 2005 | Randomized controlled trial | n = 75 |
| Efficacy of Intravenous Ketamine for Treatment of Chronic Posttraumatic Stress Disorder Patients with chronic PTSD related to a range of trauma exposures | 2014 | Randomized controlled trial | n = 41 |
| Ketamine-Induced Deficits in Auditory and Visual Context-Dependent Processing in Healthy Volunteers Healthy volunteers | 2000 | Single-blind placebo-controlled study | n = 20 |
Citations in the library
Cites 10
- NMDAR inhibition-independent antidepressant actions of ketamine metabolites Nature April 24, 2016
- Measurement of dissociative states with the Clinician‐Administered Dissociative States Scale (CADSS) Journal of Traumatic Stress 1998
- A Consensus Statement on the Use of Ketamine in the Treatment of Mood Disorders JAMA Psychiatry March 1, 2017
- Side-effects associated with ketamine use in depression: a systematic review. The Lancet Psychiatry 2018
- A Double-Blind, Randomized, Placebo-Controlled, Dose-Frequency Study of Intravenous Ketamine in Patients With Treatment-Resistant Depression American Journal of Psychiatry April 8, 2016
and 5 more in the library