Clinical trial · Interventional
Ketamine and Postoperative Depressive Symptom-PASSION
Effect of Low-dose Ketamine on Postoperative Depressive Symptom in Patients Undergoing Intracranial Tumor Resection (PASSION)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Perioperative depression symptom (PDS) is one of the common mental comorbidity, and influences the clinical outcomes and prognosis. However, there is no rapid acting treatment to deal with it during the limited hospital stay. This study aims to determine whether ketamine could improve the depressive symptom of peirioperative patients. It will also examine the safety for administrating ketamine as an antidepressant intraoperatively. Meanwhile, it will show if ketamine could improve anxiety, postoperative pain or delirium. This trial also will bring great concerns on patients with perioperative mental health and explore the measures to improve their psycho-related prognosis.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ketamine; Depressive Symptom; Neurosurgery; Perioperative Period | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ketamine | Drug | — | UNRESOLVED |
| Normal saline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ketamine group
- interventionNames
- Drug: Ketamine
- type
- PLACEBO_COMPARATOR
- label
- normal saline group
- interventionNames
- Drug: Normal saline
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- Postoperative 3 days
- description
- ≥50% reduction in MADRS scores from baseline value.The MADRS is a 10-item tool, with scores ranging from 0 to 60, and determining the severity of depression.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Brain tumor located supratentorial area and need to receive elective craniotomy; 2. Moderate to severe depressive symptom measured by the qualified psychiatric doctors. 3. Ages between 18 and 65 years old. 4. American Society of Anesthesiologists physical status I-III Exclusion Criteria: 1. History of epilepsy; 2. Major depression disorder patients undergoing antidepressive therapy within 2 weeks; 3 Psychiatric illness; 4 Drug abuse; 5 History of allergy to the research drug; 6 Tumor located in the Wernick area, Broca area or the frontal pole; 7 Hyperthyroidism; 8 Patients can not cooperate with investigators on psychiatric assessments; 9 Pregnant or breast-feeding woman; 10 refuse to sign inform consent.
References
Publications (2)
- DERIVEDZhou Y, Sun W, Zhang G, Wang A, Lin S, Chan MTV, Peng Y, Wang G, Han R. Ketamine Alleviates Depressive Symptoms in Patients Undergoing Intracranial Tumor Resection: A Randomized Controlled Trial. Anesth Analg. 2021 Dec 1;133(6):1588-1597. doi: 10.1213/ANE.0000000000005752. PMID 34633992
- DERIVEDZhou Y, Peng Y, Fang J, Sun W, Zhang G, Zhen L, Wang G, Han R. Effect of low-dose ketamine on PerioperAtive depreSsive Symptoms in patients undergoing Intracranial tumOr resectioN (PASSION): study protocol for a randomized controlled trial. Trials. 2018 Aug 29;19(1):463. doi: 10.1186/s13063-018-2831-0. PMID 30157913