EsketamineNCT06389344
Effect of Esketamine on Conscious State in Patients With pDoC
A study testing Esketamine and normal saline in people with Esketamine and Consciousness Disorders, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Esketamine, Consciousness Disorders
- What is being tested?
- Esketamine and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1.16-65 years old 2.Native Chinese language 3.pDoC after acquired brain injury 4.Scheduled to undergo surgery 5.Signed informed consent
Who cannot join
- Continuous sedation treatment was carried out within 72 hours before the study
- Airway stenosis and severe ventilation or ventilation dysfunction caused by various reasons
- Known or suspected to have serious cardiac, pulmonary and renal dysfunction 1)Severe cardiac dysfunction: a. unstable coronary syndrome b. Congestive heart failure: left ventricular ejection fraction less than 50%, elevated BNP c.Severe arrhythmia d. History of severe valvular disease 2)Severe pulmonary dysfunction: a. history of pulmonary heart disease b. History of chronic obstructive pulmonary disease 3)Severe renal dysfunction: a. Endogenous creatinine clearance (Ccr) less than 30ml/min b. The glomerular filtration rate (GFR) was less than 30ml/min•1.73m2
- Allergic history of sedative drugs
- Combined with other mental or nervous system diseases
- Other reasons are not suitable for this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Ruquan Han, MD,PhD, 8610-59976660, ruquan.han@gmail.com
Ruquan Han, MD,PhD
About this study
Official title: Effect of Esketamine on Conscious State in Patients With Prolonged Disorders of Consciousness#a Prospective, Randomized, Exploratory Study
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.
- Conditions
- Esketamine, Consciousness Disorders
- Being tested
- Esketamine, normal saline
- Medical subject headings
- Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsketamineDrug
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 salineDrug
Same amount of normal saline will be infused intravenously at a constant speed within 30 min after tracheal intubation/pneumatectomy fixation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Esketamine |
| 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. Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coma recovery scale-revised(CRS-R)
The CRS-R ranges from 0 to 23, with a higher score indicating a better state of consciousness.
Measured: 3±1 day after surgery
Secondary outcomes (9)
Coma recovery scale-revised(CRS-R)
The CRS-R ranges from 0 to 23,with a higher score indicating a better state of consciousness.
Measured: 1,3,6 months after surgery
Full Outline of UnResponsiveness(FOUR)
The FOUR ranges from 0 to 16, with a higher score indicating a better state of consciousness.
Measured: 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.
Measured: 3±1 day, 1,3,6 months after surgery
Original EEG
Measured: during surgery and 3±1 day after surgery
Patient state index(PSI)
Measured: during surgery and 3±1 day after surgery
Power spectral density
Measured: during surgery and 3±1 day after surgery
Burst-suppression ratio
Measured: during surgery and 3±1 day after surgery
Spectral edge frequency
Measured: during surgery and 3±1 day after surgery
The incidence of perioperative adverse events
Measured: 3±1 day, 1,3,6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start20 May 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EsketamineStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruquan Han, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389344
- Sponsor's protocol ID
- lk20240401
- Status last verified
- Jul 2024
- First submitted
- 17 Apr 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Esketamine on Conscious State in Patients With Prolonged Disorders of Consciousness#a Prospective, Randomized, Exploratory Study
- ClinicalTrials.gov ID
- NCT06389344
- Acronym / sponsor ID
- lk20240401
- Conditions
- Esketamine, Consciousness Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 20 May 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| esketamine | Experimental | Drug: EsketamineEsketamine ( 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 | Drug: normal salineSame amount of normal saline will be infused intravenously at a constant speed within 30 min after tracheal intubation/pneumatectomy fixation. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1.16-65 years old 2.Native Chinese language 3.pDoC after acquired brain injury 4.Scheduled to undergo surgery 5.Signed informed consent
Key exclusion criteria (6 listed)
- Continuous sedation treatment was carried out within 72 hours before the study
- Airway stenosis and severe ventilation or ventilation dysfunction caused by various reasons
- Known or suspected to have serious cardiac, pulmonary and renal dysfunction 1)Severe cardiac dysfunction: a. unstable coronary syndrome b. Congestive heart failure: left ventricular ejection fraction less than 50%, elevated BNP c.Severe arrhythmia d. History of severe valvular disease 2)Severe pulmonary dysfunction: a. history of pulmonary heart disease b. History of chronic obstructive pulmonary disease 3)Severe renal dysfunction: a. Endogenous creatinine clearance (Ccr) less than 30ml/min b. The glomerular filtration rate (GFR) was less than 30ml/min•1.73m2
- Allergic history of sedative drugs
- Combined with other mental or nervous system diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EsketamineEsketamine ( 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. | Drug | esketamine |
| normal salineSame amount of normal saline will be infused intravenously at a constant speed within 30 min after tracheal intubation/pneumatectomy fixation. | Drug | normal saline |
Primary outcome
Coma recovery scale-revised(CRS-R)
Time frame: 3±1 day after surgery
The CRS-R ranges from 0 to 23, with a higher score indicating a better state of consciousness.
9 secondary outcomes
Coma recovery scale-revised(CRS-R)
Time frame: 1,3,6 months after surgery
Full Outline of UnResponsiveness(FOUR)
Time frame: 3±1 day, 1,3,6 months after surgery
Glasgow coma scale(GCS)
Time frame: 3±1 day, 1,3,6 months after surgery
Original EEG
Time frame: during surgery and 3±1 day after surgery
Patient state index(PSI)
Time frame: during surgery and 3±1 day after surgery
Power spectral density
Time frame: during surgery and 3±1 day after surgery
Burst-suppression ratio
Time frame: during surgery and 3±1 day after surgery
Spectral edge frequency
Time frame: during surgery and 3±1 day after surgery
The incidence of perioperative adverse events
Time frame: 3±1 day, 1,3,6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esketamine and normal saline in people with Esketamine and Consciousness Disorders, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruquan Han, M.D (8610-59976660, ruquan.han@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coma recovery scale-revised(CRS-R) (time frame: 3±1 day after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.