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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ketamine group | Experimental |
| |
| normal saline group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | Ketamine will be administrated intravenously at dural opening, with the total dose of 0.5 mg/kg and continual infusion for 40 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | ≥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. | Postoperative 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| The remission rate | The remission rate is defined as the absolute value of MADRS no more than 10. | Postoperative 3 days and discharge. |
| Anxiety symptom | The anxious symptom is defined as HADS score no less than 11. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ruquan Han, M.D., Ph.D | Department of Anesthesiology, Beijing Tiantan Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing TianTan Hospital | Beijing | 100070 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34633992 | Derived | Zhou 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. | |
| 30157913 | Derived | Zhou 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. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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|
| Normal saline | Drug | Normal saline will be administrated intravenously at dural opening, with the total dose of 0.5 ml/kg and continual infusion for 40 minutes. |
|
| Postoperative 3 days. |
| Postoperative delirium | Postoperative delirium will be assessed by the Confusion Assessment Method for the Intensive Care Unit Scale (CAM-ICU) at 2 hours and 1 day after surgery. | Postoperative 1 day. |
| Severe pain | The incidence of severe pain within first postoperative three days, which is defined as mean and peak numerical rating scale (NRS) are higher than 5. | Postoperative 3 days. |
| Postoperative 30-day quality of life reported by KPS | The quality of life will be evaluated by Karnofsky performance status (KPS) at postoperative 30 days. | Postoperative 30 days |
| Psychiatric outcomes and complications | Postoperative complications include psychiatric symptoms evaluated by Brief Psychiatric Rating Scale (BPRS), manic symptoms assessed through the 11-item Young Mania Rating Scale (YMRS), and dissociative symptoms measured by the Clinician Administered Dissociative States Scale (CADSS). Moreover, postoperative complications also include aphasia, epilepsy, hemorrhage. | Postoperative 3 days and discharge. |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |