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The goal of this clinical trial is to learn about the effect of intraoperative infusion of subanesthetic dose of esketamine on conscious status in patients with prolonged disorders of consciousness under sevoflurane anesthesia.
Participants will be patients with prolonged disorders of consciousness undergoing surgery with general anesthesia at Beijing Tiantan Hospital. 0.3mg/kg esketamine or saline will be infused will be infused intravenously at a constant speed within 30 min after tracheal intubation/pneumatectomy fixation. Coma recovery scale-revised, Glasgow coma scale, Full Outline of UnResponsiveness scores, SedLine multi-channel electroencephalogram and perioperative adverse events after surgery will be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| esketamine | Experimental | Esketamine ( 50mg, dissolved in 50ml normal saline ) 0.3mg / kg will be infused intravenously at a constant speed within 30 min after tracheal intubation/pneumatectomy fixation. |
|
| normal saline | Placebo Comparator | Same amount of normal saline will be infused intravenously at a constant speed within 30 min after tracheal intubation/pneumatectomy fixation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esketamine | Drug | Esketamine ( 50mg, dissolved in 50ml normal saline ) 0.3mg / kg will be infused intravenously at a constant speed within 30 min after tracheal intubation/pneumatectomy fixation. |
| Measure | Description | Time Frame |
|---|---|---|
| Coma recovery scale-revised(CRS-R) | The CRS-R ranges from 0 to 23, with a higher score indicating a better state of consciousness. | 3±1 day after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Coma recovery scale-revised(CRS-R) | The CRS-R ranges from 0 to 23,with a higher score indicating a better state of consciousness. | 1,3,6 months after surgery |
| Full Outline of UnResponsiveness(FOUR) |
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Inclusion Criteria:
1.16-65 years old 2.Native Chinese language 3.pDoC after acquired brain injury 4.Scheduled to undergo surgery 5.Signed informed consent
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruquan Han, M.D | Contact | 8610-59976660 | ruquan.han@ccmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100070 | China |
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| ID | Term |
|---|---|
| D003244 | Consciousness Disorders |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C000629870 | Esketamine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| normal saline | Drug | Same amount of normal saline will be infused intravenously at a constant speed within 30 min after tracheal intubation/pneumatectomy fixation. |
|
The FOUR ranges from 0 to 16, with a higher score indicating a better state of consciousness.
| 3±1 day, 1,3,6 months after surgery |
| Glasgow coma scale(GCS) | The GCS ranges from 3 to 15,with a higher score indicating a better state of consciousness. | 3±1 day, 1,3,6 months after surgery |
| Original EEG | during surgery and 3±1 day after surgery |
| Patient state index(PSI) | during surgery and 3±1 day after surgery |
| Power spectral density | during surgery and 3±1 day after surgery |
| Burst-suppression ratio | during surgery and 3±1 day after surgery |
| Spectral edge frequency | during surgery and 3±1 day after surgery |
| The incidence of perioperative adverse events | 3±1 day, 1,3,6 months after surgery |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |